ID

4508

Description

ODM derived from http://clinicaltrials.gov/show/NCT00640016

Link

http://clinicaltrials.gov/show/NCT00640016

Keywords

  1. 12/9/13 12/9/13 - Martin Dugas
  2. 8/8/14 8/8/14 - Martin Dugas
  3. 5/22/15 5/22/15 - Martin Dugas
  4. 9/20/21 9/20/21 -
Uploaded on

December 9, 2013

DOI

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License

Creative Commons BY-NC 3.0 Legacy

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Eligibility NCT00640016 Asthma

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
age 18 Years to 80 Years
Description

age 18 Years to 80 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Signed and dated written informed consent is obtained prior to any study related procedure taking place.
Description

Signed and dated written informed consent is obtained prior to any study related procedure taking place.

Data type

boolean

Alias
UMLS CUI 2011AA
C1519316
UMLS CUI 2011AA
C0011008
SNOMED CT 2011_0131
410671006
LOINC Version 232
MTHU021546
UMLS CUI 2011AA
C1576874
HL7 V3 2006_05
WRITTEN
UMLS CUI 2011AA
C0021430
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0680734
Women either infertile (e.g. hysterectomised, sterile or post menopausal with amenorrhoea of least one year duration) or who are practicing an acceptable form of birth control (contraceptive pill or double-barrier contraception
Description

Women either infertile (e.g. hysterectomised, sterile or post menopausal with amenorrhoea of least one year duration) or who are practicing an acceptable form of birth control (contraceptive pill or double-barrier contraception

Data type

boolean

Alias
UMLS CUI 2011AA
C0043210
SNOMED CT 2011_0131
224526002
UMLS CUI 2011AA
C0021359
SNOMED CT 2011_0131
8619003
MedDRA 14.1
10021926
UMLS CUI 2011AA
C0020699
SNOMED CT 2011_0131
236886002
MedDRA 14.1
10021151
UMLS CUI 2011AA
C0232970
SNOMED CT 2011_0131
76498008
UMLS CUI 2011AA
C0002453
SNOMED CT 2011_0131
14302001
MedDRA 14.1
10001928
ICD-10-CM Version 2010
N91.2
ICD-9-CM Version 2011
626.0
UMLS CUI 2011AA
C0439234
SNOMED CT 2011_0131
258707000
HL7 V3 2006_05
Y
UMLS CUI 2011AA
C0700589
SNOMED CT 2011_0131
146680009
MedDRA 14.1
10010808
UMLS CUI 2011AA
C0009905
SNOMED CT 2011_0131
59261009
UMLS CUI 2011AA
C0004764
SNOMED CT 2011_0131
225370004
UMLS CUI 2011AA
C0205173
SNOMED CT 2011_0131
1305003
partner using condom and subject using spermicide, diaphragm, intra-uterine device or contraceptive sponge) for 1 month prior to Visit 1 (screening visit) or longer if requested by the investigator. Women of childbearing potential must continue to practice birth control during the study and for at least 2 months after completing the study. Women of childbearing potential must have a negative pregnancy test at screening and Visit 2, 5, 7 and 9.
Description

partner using condom and subject using spermicide, diaphragm, intra-uterine device or contraceptive sponge) for 1 month prior to Visit 1 (screening visit) or longer if requested by the investigator. Women of childbearing potential must continue to practice birth control during the study and for at least 2 months after completing the study. Women of childbearing potential must have a negative pregnancy test at screening and Visit 2, 5, 7 and 9.

Data type

boolean

Alias
UMLS CUI 2011AA
C0682323
SNOMED CT 2011_0131
262043009
HL7 V3 2006_05
SIGOTHR
UMLS CUI 2011AA
C1524063
SNOMED CT 2011_0131
260676000
UMLS CUI 2011AA
C0677582
UMLS CUI 2011AA
C0681850
UMLS CUI 2011AA
C1524063
SNOMED CT 2011_0131
260676000
UMLS CUI 2011AA
C0037862
SNOMED CT 2011_0131
425484006
UMLS CUI 2011AA
C0042241
SNOMED CT 2011_0131
20359006
UMLS CUI 2011AA
C0021900
SNOMED CT 2011_0131
268460000
MedDRA 14.1
10022745
UMLS CUI 2011AA
C0183461
SNOMED CT 2011_0131
169529008
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1409616
UMLS CUI 2011AA
C1554196
HL7 V3 2006_05
ENC
UMLS CUI 2011AA
C0205172
SNOMED CT 2011_0131
242762006
UMLS CUI 2011AA
C1272683
SNOMED CT 2011_0131
385644000
UMLS CUI 2011AA
CL102947
UMLS CUI 2011AA
C0043210
SNOMED CT 2011_0131
224526002
UMLS CUI 2011AA
C1148523
UMLS CUI 2011AA
C0237399
UMLS CUI 2011AA
C0750536
UMLS CUI 2011AA
C0700589
SNOMED CT 2011_0131
146680009
MedDRA 14.1
10010808
UMLS CUI 2011AA
C0347984
SNOMED CT 2011_0131
371881003
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0205448
SNOMED CT 2011_0131
19338005
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
UMLS CUI 2011AA
C0231290
SNOMED CT 2011_0131
237679004
UMLS CUI 2011AA
CL421124
UMLS CUI 2011AA
C0427780
SNOMED CT 2011_0131
250425007
MedDRA 14.1
10036574
UMLS CUI 2011AA
C1409616
UMLS CUI 2011AA
C1554196
HL7 V3 2006_05
ENC
Uncontrolled (refractory) asthma despite optimal treatment
Description

Uncontrolled (refractory) asthma despite optimal treatment

Data type

boolean

Alias
UMLS CUI 2011AA
C0205318
SNOMED CT 2011_0131
19032002
UMLS CUI 2011AA
C0205269
SNOMED CT 2011_0131
20646008
UMLS CUI 2011AA
C0004096
SNOMED CT 2011_0131
195967001
MedDRA 14.1
10003553
LOINC Version 232
MTHU020815
ICD-10-CM Version 2010
J45
ICD-9-CM Version 2011
493
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0521124
SNOMED CT 2011_0131
65897001
UMLS CUI 2011AA
C2698651
UMLS CUI 2011AA
C0039798
subjects will have Global Initiative for Asthma (GINA 2006) clinical features of uncontrolled asthma despite treatment with a minimum dose of 800 µg beclomethasone dipropionate or equivalent inhaled corticosteroid per day plus one or more additional controller i.e. long-acting b-agonist, leukotriene antagonist or theophylline. Oral corticosteroids (not parenteral) as additional treatment at any dose are acceptable. The dose of inhaled and oral corticosteroids must have been stable within 4 weeks preceding Visit 1 (screening visit) and will be expected to remain stable for the duration of the study. If subjects are on single inhaler combination products at Visit 1 (e.g. fluticasone/salmeterol - Advair/Seretide or Symbicort (budesonide/formoterol) SMART) they must receive the two components as two separate inhaler medications for the purpose of the trial. This will facilitate withholding the long-acting b-agonist component before lung function and challenge testing (see Section 9.5.7). The GINA 2006 [14] levels of asthma control and treatment are described in Appendix 3.
Description

subjects will have Global Initiative for Asthma (GINA 2006) clinical features of uncontrolled asthma despite treatment with a minimum dose of 800 µg beclomethasone dipropionate or equivalent inhaled corticosteroid per day plus one or more additional controller i.e. long-acting b-agonist, leukotriene antagonist or theophylline. Oral corticosteroids (not parenteral) as additional treatment at any dose are acceptable. The dose of inhaled and oral corticosteroids must have been stable within 4 weeks preceding Visit 1 (screening visit) and will be expected to remain stable for the duration of the study. If subjects are on single inhaler combination products at Visit 1 (e.g. fluticasone/salmeterol - Advair/Seretide or Symbicort (budesonide/formoterol) SMART) they must receive the two components as two separate inhaler medications for the purpose of the trial. This will facilitate withholding the long-acting b-agonist component before lung function and challenge testing (see Section 9.5.7). The GINA 2006 [14] levels of asthma control and treatment are described in Appendix 3.

Data type

boolean

Alias
UMLS CUI 2011AA
C0681850
UMLS CUI 2011AA
C0205318
SNOMED CT 2011_0131
19032002
UMLS CUI 2011AA
C0205269
SNOMED CT 2011_0131
20646008
UMLS CUI 2011AA
C0004096
SNOMED CT 2011_0131
195967001
MedDRA 14.1
10003553
LOINC Version 232
MTHU020815
ICD-10-CM Version 2010
J45
ICD-9-CM Version 2011
493
UMLS CUI 2011AA
C0521124
SNOMED CT 2011_0131
65897001
UMLS CUI 2011AA
C2698651
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C2348867
UMLS CUI 2011AA
C0424093
SNOMED CT 2011_0131
247756008
UMLS CUI 2011AA
C0004096
SNOMED CT 2011_0131
195967001
MedDRA 14.1
10003553
LOINC Version 232
MTHU020815
ICD-10-CM Version 2010
J45
ICD-9-CM Version 2011
493
UMLS CUI 2011AA
C0205210
SNOMED CT 2011_0131
58147004
UMLS CUI 2011AA
C2348519
UMLS CUI 2011AA
C1524031
UMLS CUI 2011AA
C0178602
SNOMED CT 2011_0131
260911001
UMLS CUI 2011AA
C0004906
SNOMED CT 2011_0131
116575004
LOINC Version 232
MTHU017342
UMLS CUI 2011AA
CL415123
UMLS CUI 2011AA
CL426883
UMLS CUI 2011AA
C0001617
SNOMED CT 2011_0131
79440004
UMLS CUI 2011AA
C0332173
SNOMED CT 2011_0131
69620002
UMLS CUI 2011AA
C1524062
LOINC Version 232
MTHU013802
UMLS CUI 2011AA
C2587213
SNOMED CT 2011_0131
31509003
UMLS CUI 2011AA
C0205166
SNOMED CT 2011_0131
255511005
UMLS CUI 2011AA
C0205177
SNOMED CT 2011_0131
55561003
UMLS CUI 2011AA
C0001644
SNOMED CT 2011_0131
373227004
UMLS CUI 2011AA
C0595726
SNOMED CT 2011_0131
372517002
UMLS CUI 2011AA
C0039771
SNOMED CT 2011_0131
372810006
LOINC Version 232
MTHU004269
UMLS CUI 2011AA
C1527415
SNOMED CT 2011_0131
26643006
HL7 V3 2006_05
_OralRoute
UMLS CUI 2011AA
C0001617
SNOMED CT 2011_0131
79440004
UMLS CUI 2011AA
C1524062
LOINC Version 232
MTHU013802
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0178602
SNOMED CT 2011_0131
260911001
UMLS CUI 2011AA
C0205360
SNOMED CT 2011_0131
58158008
LOINC Version 232
MTHU015276
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1554196
HL7 V3 2006_05
ENC
UMLS CUI 2011AA
C1409616
UMLS CUI 2011AA
C0489652
LOINC Version 232
MTHU024501
UMLS CUI 2011AA
C0681850
UMLS CUI 2011AA
C0205171
SNOMED CT 2011_0131
50607009
UMLS CUI 2011AA
C0021461
SNOMED CT 2011_0131
334980009
HL7 V3 2006_05
INH
UMLS CUI 2011AA
C1947911
UMLS CUI 2011AA
C1514468
UMLS CUI 2011AA
C1554196
HL7 V3 2006_05
ENC
UMLS CUI 2011AA
C0082607
SNOMED CT 2011_0131
397192001
UMLS CUI 2011AA
C0073992
SNOMED CT 2011_0131
372515005
UMLS CUI 2011AA
C0965130
UMLS CUI 2011AA
C1130494
UMLS CUI 2011AA
C1121854
UMLS CUI 2011AA
C0054201
SNOMED CT 2011_0131
395726003
LOINC Version 232
MTHU017344
UMLS CUI 2011AA
C0060657
SNOMED CT 2011_0131
414289007
UMLS CUI 2011AA
C0205448
SNOMED CT 2011_0131
19338005
UMLS CUI 2011AA
C1705248
UMLS CUI 2011AA
C0443299
SNOMED CT 2011_0131
263869007
UMLS CUI 2011AA
C0021461
SNOMED CT 2011_0131
334980009
UMLS CUI 2011AA
C0013227
UMLS CUI 2011AA
C0024119
SNOMED CT 2011_0131
23426006
MedDRA 14.1
10025099
LOINC Version 232
MTHU029811
UMLS CUI 2011AA
C1315011
LOINC Version 232
MTHU000047
A forced expiratory volume in 1 second (FEV1) acceptable for AHR challenge tests (>= 60% of predicted normal) on the challenge days.
Description

A forced expiratory volume in 1 second (FEV1) acceptable for AHR challenge tests (>= 60% of predicted normal) on the challenge days.

Data type

boolean

Alias
UMLS CUI 2011AA
CL414841
UMLS CUI 2011AA
C1879533
UMLS CUI 2011AA
C0085129
SNOMED CT 2011_0131
195967001
MedDRA 14.1
10066091
UMLS CUI 2011AA
C1315011
LOINC Version 232
MTHU000047
UMLS CUI 2011AA
C0681842
UMLS CUI 2011AA
C0205307
SNOMED CT 2011_0131
17621005
HL7 V3 2006_05
N
A provocative concentration of methacholine causing a 20% fall in FEV1 (PC20) <= 4 mg/mL.
Description

A provocative concentration of methacholine causing a 20% fall in FEV1 (PC20) <= 4 mg/mL.

Data type

boolean

Alias
UMLS CUI 2011AA
C0449428
SNOMED CT 2011_0131
272733003
UMLS CUI 2011AA
C1446561
UMLS CUI 2011AA
C0600370
SNOMED CT 2011_0131
372766003
UMLS CUI 2011AA
C0678227
SNOMED CT 2011_0131
23981006
UMLS CUI 2011AA
C0547047
SNOMED CT 2011_0131
260370003
UMLS CUI 2011AA
CL414841
Aged 18-80 years and are ambulatory and able to travel to the clinic.7. A 12-lead electrocardiogram (ECG) with no-clinically significant abnormalities.
Description

Aged 18-80 years and are ambulatory and able to travel to the clinic.7. A 12-lead electrocardiogram (ECG) with no-clinically significant abnormalities.

Data type

boolean

Alias
UMLS CUI 2011AA
C0439841
UMLS CUI 2011AA
C0085732
SNOMED CT 2011_0131
371150009
UMLS CUI 2011AA
C0040802
SNOMED CT 2011_0131
129018004
UMLS CUI 2011AA
C0442592
SNOMED CT 2011_0131
257585005
UMLS CUI 2011AA
C2960418
SNOMED CT 2011_0131
447113005
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0205210
SNOMED CT 2011_0131
58147004
UMLS CUI 2011AA
C0750502
SNOMED CT 2011_0131
386134007
UMLS CUI 2011AA
C1704258
Clinical chemistry, haematology and urinalysis results within the laboratory reference ranges or deemed not clinically significant by the Investigator.
Description

Clinical chemistry, haematology and urinalysis results within the laboratory reference ranges or deemed not clinically significant by the Investigator.

Data type

boolean

Alias
UMLS CUI 2011AA
C0008000
UMLS CUI 2011AA
C0200627
SNOMED CT 2011_0131
33468001
LOINC Version 232
MTHU008379
UMLS CUI 2011AA
C0042014
SNOMED CT 2011_0131
27171005
MedDRA 14.1
10046614
LOINC Version 232
MTHU000144
UMLS CUI 2011AA
C1274040
SNOMED CT 2011_0131
79409006
UMLS CUI 2011AA
C0332285
SNOMED CT 2011_0131
18720000
UMLS CUI 2011AA
C0022877
SNOMED CT 2011_0131
261904005
LOINC Version 232
MTHU029808
UMLS CUI 2011AA
CL415192
UMLS CUI 2011AA
CL414906
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0205210
SNOMED CT 2011_0131
58147004
UMLS CUI 2011AA
C0750502
SNOMED CT 2011_0131
386134007
UMLS CUI 2011AA
C0022423
SNOMED CT 2011_0131
61254005
UMLS CUI 2011AA
CL102947
Body weight (observable entity)
Description

Body weight of <= 130 kg.

Data type

boolean

Alias
UMLS CUI 2011AA
C0005910
SNOMED CT 2011_0131
27113001
LOINC Version 232
MTHU001885
No other clinically significant abnormality on history and clinical examination (see also Exclusion Criteria).
Description

No other clinically significant abnormality on history and clinical examination (see also Exclusion Criteria).

Data type

boolean

Alias
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0205210
SNOMED CT 2011_0131
58147004
UMLS CUI 2011AA
C0750502
SNOMED CT 2011_0131
386134007
UMLS CUI 2011AA
C1704258
UMLS CUI 2011AA
C0262926
SNOMED CT 2011_0131
417662000
LOINC Version 232
MTHU027722
UMLS CUI 2011AA
C0031809
SNOMED CT 2011_0131
5880005
MedDRA 14.1
10034986
LOINC Version 232
MTHU028014
ICD-9-CM Version 2011
89.7
Able to comply with the requirements of the protocol.
Description

Able to comply with the requirements of the protocol.

Data type

boolean

Alias
UMLS CUI 2011AA
C0085732
SNOMED CT 2011_0131
371150009
UMLS CUI 2011AA
C1321605
SNOMED CT 2011_0131
405078008
UMLS CUI 2011AA
C1709747
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
Experienced a severe exacerbation within 28 days preceding Visit 1.
Description

Experienced a severe exacerbation within 28 days preceding Visit 1.

Data type

boolean

Alias
UMLS CUI 2011AA
C0205082
SNOMED CT 2011_0131
24484000
UMLS CUI 2011AA
C1444749
SNOMED CT 2011_0131
410661009
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1554196
HL7 V3 2006_05
ENC
Onset of uncontrolled seasonal allergy symptoms within 28 days preceding Visit 1. Subjects with a history of allergic rhinitis, seasonal allergy or oesophagitis must be optimally controlled and remain on a stable treatment regimen during the study.
Description

Onset of uncontrolled seasonal allergy symptoms within 28 days preceding Visit 1. Subjects with a history of allergic rhinitis, seasonal allergy or oesophagitis must be optimally controlled and remain on a stable treatment regimen during the study.

Data type

boolean

Alias
UMLS CUI 2011AA
C0332162
SNOMED CT 2011_0131
77374008
UMLS CUI 2011AA
C0205318
SNOMED CT 2011_0131
19032002
UMLS CUI 2011AA
C0018621
SNOMED CT 2011_0131
367498001
MedDRA 14.1
10048908
ICD-10-CM Version 2010
J30.1
ICD-9-CM Version 2011
477.0
UMLS CUI 2011AA
C1457887
LOINC Version 232
MTHU021540
ICD-9-CM Version 2011
780-789.99
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1554196
HL7 V3 2006_05
ENC
UMLS CUI 2011AA
C0681850
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C2607914
SNOMED CT 2011_0131
61582004
MedDRA 14.1
10039085
ICD-10-CM Version 2010
J30.9
ICD-9-CM Version 2011
477.9
CTCAE 1105E
E13303
UMLS CUI 2011AA
C0018621
SNOMED CT 2011_0131
367498001
MedDRA 14.1
10048908
ICD-10-CM Version 2010
J30.1
ICD-9-CM Version 2011
477.0
UMLS CUI 2011AA
C0014868
SNOMED CT 2011_0131
16761005
MedDRA 14.1
10030216
ICD-10-CM Version 2010
K20.9
ICD-9-CM Version 2011
530.10
CTCAE 1105E
E10687
UMLS CUI 2011AA
C2698651
UMLS CUI 2011AA
C2587213
SNOMED CT 2011_0131
31509003
UMLS CUI 2011AA
C0205360
SNOMED CT 2011_0131
58158008
LOINC Version 232
MTHU015276
UMLS CUI 2011AA
CL031856
UMLS CUI 2011AA
C0347984
SNOMED CT 2011_0131
371881003
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
Participation in another study within five half lives or three months of the start of this study, whichever is the longer. This does not apply to methodological or observational studies in which no investigational medicinal product (IMP) was given.
Description

Participation in another study within five half lives or three months of the start of this study, whichever is the longer. This does not apply to methodological or observational studies in which no investigational medicinal product (IMP) was given.

Data type

boolean

Alias
UMLS CUI 2011AA
C0679823
HL7 V3 2006_05
PART
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0018517
UMLS CUI 2011AA
C2825406
UMLS CUI 2011AA
C0439234
SNOMED CT 2011_0131
258707000
HL7 V3 2006_05
Y
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
CL025718
UMLS CUI 2011AA
C0025662
UMLS CUI 2011AA
C1518527
UMLS CUI 2011AA
C0332197
SNOMED CT 2011_0131
2667000
UMLS CUI 2011AA
C1517586
UMLS CUI 2011AA
C0205476
SNOMED CT 2011_0131
74188005
UMLS CUI 2011AA
C1514468
Lower respiratory tract infection within six weeks of Visit 1.5.
Description

Lower respiratory tract infection within six weeks of Visit 1.5.

Data type

boolean

Alias
UMLS CUI 2011AA
C0149725
SNOMED CT 2011_0131
50417007
MedDRA 14.1
10024968
UMLS CUI 2011AA
C0439230
SNOMED CT 2011_0131
258705008
HL7 V3 2006_05
WK
UMLS CUI 2011AA
C1554196
HL7 V3 2006_05
ENC
Current smokers or ex-smokers with > 10 pack-years (number of pack years = (number of cigarettes per day/20) x number of years smoked, e.g., 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years).
Description

Current smokers or ex-smokers with > 10 pack-years (number of pack years = (number of cigarettes per day/20) x number of years smoked, e.g., 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years).

Data type

boolean

Alias
UMLS CUI 2011AA
C0337664
SNOMED CT 2011_0131
77176002
MedDRA 14.1
10048880
UMLS CUI 2011AA
C0337671
SNOMED CT 2011_0131
8517006
MedDRA 14.1
10015572
UMLS CUI 2011AA
C1277691
SNOMED CT 2011_0131
315609007
UMLS CUI 2011AA
C0237753
SNOMED CT 2011_0131
260299005
LOINC Version 232
MTHU024869
UMLS CUI 2011AA
C0677453
UMLS CUI 2011AA
C0439228
SNOMED CT 2011_0131
258703001
HL7 V3 2006_05
D
UMLS CUI 2011AA
C0439234
SNOMED CT 2011_0131
258707000
HL7 V3 2006_05
Y
Blood donation (> 550 mL) in the previous two months.
Description

Blood donation (> 550 mL) in the previous two months.

Data type

boolean

Alias
UMLS CUI 2011AA
C0005794
SNOMED CT 2011_0131
25179006
UMLS CUI 2011AA
C0205156
SNOMED CT 2011_0131
9130008
UMLS CUI 2011AA
C0205448
SNOMED CT 2011_0131
19338005
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
Excessive intake of alcohol (as judged by the Investigator) or evidence of drug or solvent abuse.
Description

Excessive intake of alcohol (as judged by the Investigator) or evidence of drug or solvent abuse.

Data type

boolean

Alias
UMLS CUI 2011AA
C0560219
SNOMED CT 2011_0131
160592001
UMLS CUI 2011AA
C0022423
SNOMED CT 2011_0131
61254005
UMLS CUI 2011AA
CL102947
UMLS CUI 2011AA
C0332120
SNOMED CT 2011_0131
18669006
UMLS CUI 2011AA
C0013146
SNOMED CT 2011_0131
26416006
MedDRA 14.1
10013654
LOINC Version 232
LP36310-8
ICD-9-CM Version 2011
305.90
UMLS CUI 2011AA
C0037638
SNOMED CT 2011_0131
61010005
UMLS CUI 2011AA
C1328247
SNOMED CT 2011_0131
417928002
MedDRA 14.1
10000341
Subjects with a physician-diagnosis of any other significant lung disease, including a primary diagnosis of chronic obstructive pulmonary disease or bronchiectasis, or lung cancer, sarcoidosis, tuberculosis, pulmonary fibrosis and cystic fibrosis.
Description

Subjects with a physician-diagnosis of any other significant lung disease, including a primary diagnosis of chronic obstructive pulmonary disease or bronchiectasis, or lung cancer, sarcoidosis, tuberculosis, pulmonary fibrosis and cystic fibrosis.

Data type

boolean

Alias
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0031831
SNOMED CT 2011_0131
309343006
LOINC Version 232
MTHU010489
HL7 V3 2006_05
PHYS
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0750502
SNOMED CT 2011_0131
386134007
UMLS CUI 2011AA
C0024115
SNOMED CT 2011_0131
19829001
MedDRA 14.1
10025082
ICD-10-CM Version 2010
J98.4
UMLS CUI 2011AA
C0332257
SNOMED CT 2011_0131
55919000
UMLS CUI 2011AA
C0801658
LOINC Version 232
18630-4
UMLS CUI 2011AA
C0024117
SNOMED CT 2011_0131
13645005
MedDRA 14.1
10009033
ICD-10-CM Version 2010
J44.9
ICD-9-CM Version 2011
496
UMLS CUI 2011AA
C0006267
SNOMED CT 2011_0131
12295008
MedDRA 14.1
10006445
ICD-10-CM Version 2010
J47.9
ICD-9-CM Version 2011
494
UMLS CUI 2011AA
C0242379
SNOMED CT 2011_0131
363358000
MedDRA 14.1
10058467
ICD-10-CM Version 2010
C34.90
UMLS CUI 2011AA
C0036202
SNOMED CT 2011_0131
31541009
MedDRA 14.1
10039486
ICD-10-CM Version 2010
D86.9
ICD-9-CM Version 2011
135
UMLS CUI 2011AA
C0041296
SNOMED CT 2011_0131
56717001
MedDRA 14.1
10044755
LOINC Version 232
MTHU020835
ICD-10-CM Version 2010
A15-A19
ICD-9-CM Version 2011
010-018.99
UMLS CUI 2011AA
C0034069
SNOMED CT 2011_0131
51615001
MedDRA 14.1
10037383
ICD-10-CM Version 2010
J84.1
CTCAE 1105E
E13527
UMLS CUI 2011AA
C0010674
SNOMED CT 2011_0131
190905008
MedDRA 14.1
10011762
LOINC Version 232
MTHU021607
ICD-10-CM Version 2010
E84
ICD-9-CM Version 2011
277.0
Concurrent medication from Visit 1 (screening visit) and for the duration of the study with any of the prohibited medications.
Description

Concurrent medication from Visit 1 (screening visit) and for the duration of the study with any of the prohibited medications.

Data type

boolean

Alias
UMLS CUI 2011AA
C0205420
SNOMED CT 2011_0131
68405009
UMLS CUI 2011AA
C0013227
UMLS CUI 2011AA
C1554196
HL7 V3 2006_05
ENC
UMLS CUI 2011AA
C1409616
UMLS CUI 2011AA
C0489652
LOINC Version 232
MTHU024501
UMLS CUI 2011AA
C0683610
UMLS CUI 2011AA
C0013227
Significant, uncontrolled disease including serious psychological disorders, chronic renal failure, uncontrolled hypertension
Description

Significant, uncontrolled disease including serious psychological disorders, chronic renal failure, uncontrolled hypertension

Data type

boolean

Alias
UMLS CUI 2011AA
C0750502
SNOMED CT 2011_0131
386134007
UMLS CUI 2011AA
C0205318
SNOMED CT 2011_0131
19032002
UMLS CUI 2011AA
C0012634
SNOMED CT 2011_0131
64572001
UMLS CUI 2011AA
C0332257
SNOMED CT 2011_0131
55919000
UMLS CUI 2011AA
C0205404
SNOMED CT 2011_0131
42745003
UMLS CUI 2011AA
C0004936
SNOMED CT 2011_0131
74732009
MedDRA 14.1
10037174
ICD-10-CM Version 2010
F99
ICD-9-CM Version 2011
290-319.99
UMLS CUI 2011AA
C0022661
SNOMED CT 2011_0131
90688005
MedDRA 14.1
10038444
ICD-10-CM Version 2010
N18.9
ICD-9-CM Version 2011
585.6
UMLS CUI 2011AA
C1868885
MedDRA 14.1
10066860
systolic blood pressure > 200 mmHg, or diastolic blood pressure > 100 mmHg, heart disease, psoriasis requiring treatment and subjects who have had a heart attack or stroke within the 3 months preceding Visit 1, or who have a known aneurysm.
Description

systolic blood pressure > 200 mmHg, or diastolic blood pressure > 100 mmHg, heart disease, psoriasis requiring treatment and subjects who have had a heart attack or stroke within the 3 months preceding Visit 1, or who have a known aneurysm.

Data type

boolean

Alias
UMLS CUI 2011AA
C0871470
SNOMED CT 2011_0131
271649006
UMLS CUI 2011AA
C0428883
SNOMED CT 2011_0131
271650006
UMLS CUI 2011AA
C0018799
SNOMED CT 2011_0131
56265001
MedDRA 14.1
10061024
ICD-10-CM Version 2010
I51.9
ICD-9-CM Version 2011
429.9
UMLS CUI 2011AA
C0033860
SNOMED CT 2011_0131
9014002
MedDRA 14.1
10037153
ICD-10-CM Version 2010
L40
UMLS CUI 2011AA
C1514873
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0027051
SNOMED CT 2011_0131
22298006
MedDRA 14.1
10028596
LOINC Version 232
MTHU035551
ICD-10-CM Version 2010
I21-I22
ICD-9-CM Version 2011
410
CTCAE 1105E
E10152
UMLS CUI 2011AA
C0038454
SNOMED CT 2011_0131
230690007
MedDRA 14.1
10042244
ICD-10-CM Version 2010
I63.9
CTCAE 1105E
E12826
UMLS CUI 2011AA
C2825406
UMLS CUI 2011AA
C0439234
SNOMED CT 2011_0131
258707000
HL7 V3 2006_05
Y
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1554196
HL7 V3 2006_05
ENC
UMLS CUI 2011AA
C0205309
SNOMED CT 2011_0131
36692007
UMLS CUI 2011AA
C0002940
SNOMED CT 2011_0131
432119003
MedDRA 14.1
10002329
ICD-10-CM Version 2010
I72.9
ICD-9-CM Version 2011
442.9
Onset of uncontrolled seasonal allergy symptoms within 28 days preceding Visit 1. Subjects with a history of allergic rhinitis, seasonal allergy or oesophagitis must be optimally controlled and remain on a stable treatment regimen during the study.
Description

Onset of uncontrolled seasonal allergy symptoms within 28 days preceding Visit 1. Subjects with a history of allergic rhinitis, seasonal allergy or oesophagitis must be optimally controlled and remain on a stable treatment regimen during the study.

Data type

boolean

Alias
UMLS CUI 2011AA
C0332162
SNOMED CT 2011_0131
77374008
UMLS CUI 2011AA
C0205318
SNOMED CT 2011_0131
19032002
UMLS CUI 2011AA
C0018621
SNOMED CT 2011_0131
367498001
MedDRA 14.1
10048908
ICD-10-CM Version 2010
J30.1
ICD-9-CM Version 2011
477.0
UMLS CUI 2011AA
C1457887
LOINC Version 232
MTHU021540
ICD-9-CM Version 2011
780-789.99
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1554196
HL7 V3 2006_05
ENC
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C2607914
SNOMED CT 2011_0131
61582004
MedDRA 14.1
10039085
ICD-10-CM Version 2010
J30.9
ICD-9-CM Version 2011
477.9
CTCAE 1105E
E13303
UMLS CUI 2011AA
C0018621
SNOMED CT 2011_0131
367498001
MedDRA 14.1
10048908
ICD-10-CM Version 2010
J30.1
ICD-9-CM Version 2011
477.0
UMLS CUI 2011AA
C0014868
SNOMED CT 2011_0131
16761005
MedDRA 14.1
10030216
ICD-10-CM Version 2010
K20.9
ICD-9-CM Version 2011
530.10
CTCAE 1105E
E10687
UMLS CUI 2011AA
C2698651
UMLS CUI 2011AA
C2587213
SNOMED CT 2011_0131
31509003
UMLS CUI 2011AA
C0205360
SNOMED CT 2011_0131
58158008
LOINC Version 232
MTHU015276
UMLS CUI 2011AA
CL031856
UMLS CUI 2011AA
C0489652
LOINC Version 232
MTHU024501
Any factor which, in the opinion of the Investigator, would jeopardise the evaluation or safety or be associated with poor adherence to the protocol (i.e. inability to complete study diary, perform PEF measurements).
Description

Any factor which, in the opinion of the Investigator, would jeopardise the evaluation or safety or be associated with poor adherence to the protocol (i.e. inability to complete study diary, perform PEF measurements).

Data type

boolean

Alias
UMLS CUI 2011AA
C0022423
SNOMED CT 2011_0131
61254005
UMLS CUI 2011AA
CL102947
UMLS CUI 2011AA
C0035648
SNOMED CT 2011_0131
80943009
LOINC Version 232
MTHU028018
UMLS CUI 2011AA
C0220825
UMLS CUI 2011AA
C0036043
UMLS CUI 2011AA
C0332281
SNOMED CT 2011_0131
47429007
UMLS CUI 2011AA
C0205169
SNOMED CT 2011_0131
556001
UMLS CUI 2011AA
C0525058
UMLS CUI 2011AA
C1299582
SNOMED CT 2011_0131
371151008
UMLS CUI 2011AA
C1554962
HL7 V3 2006_05
C
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0376660
UMLS CUI 2011AA
C1882330
UMLS CUI 2011AA
C0030735
MedDRA 14.1
10034192
The subject's primary care physician recommends the subject should not take part in the study.
Description

The subject's primary care physician recommends the subject should not take part in the study.

Data type

boolean

Alias
UMLS CUI 2011AA
C0033131, C0017319
SNOMED CT 2011_0131
446050000, 59058001
UMLS CUI 2011AA
C0034866
LOINC Version 232
MTHU036724
HL7 V3 2006_05
RMD
UMLS CUI 2011AA
C0030705
SNOMED CT 2011_0131
116154003
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0679823
HL7 V3 2006_05
PART
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
Known hypersensitivity to CAT-354 or its components, to the challenge agents used in the study or to related drugs.
Description

Known hypersensitivity to CAT-354 or its components, to the challenge agents used in the study or to related drugs.

Data type

boolean

Alias
UMLS CUI 2011AA
C0205309
SNOMED CT 2011_0131
36692007
UMLS CUI 2011AA
C0020517
SNOMED CT 2011_0131
418634005
ICD-10-CM Version 2010
T78.40
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0013227
UMLS CUI 2011AA
C1705248
UMLS CUI 2011AA
C0805586
LOINC Version 232
MTHU005364
UMLS CUI 2011AA
C1254351
UMLS CUI 2011AA
C0445223
SNOMED CT 2011_0131
262094002
UMLS CUI 2011AA
C0013227
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008

Similar models

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
CL425202 (UMLS CUI 2011AA)
age 18 Years to 80 Years
Item
age 18 Years to 80 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Signed and dated written informed consent is obtained prior to any study related procedure taking place.
Item
Signed and dated written informed consent is obtained prior to any study related procedure taking place.
boolean
C1519316 (UMLS CUI 2011AA)
C0011008 (UMLS CUI 2011AA)
410671006 (SNOMED CT 2011_0131)
MTHU021546 (LOINC Version 232)
C1576874 (UMLS CUI 2011AA)
WRITTEN (HL7 V3 2006_05)
C0021430 (UMLS CUI 2011AA)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0680734 (UMLS CUI 2011AA)
Women either infertile (e.g. hysterectomised, sterile or post menopausal with amenorrhoea of least one year duration) or who are practicing an acceptable form of birth control (contraceptive pill or double-barrier contraception
Item
Women either infertile (e.g. hysterectomised, sterile or post menopausal with amenorrhoea of least one year duration) or who are practicing an acceptable form of birth control (contraceptive pill or double-barrier contraception
boolean
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
C0021359 (UMLS CUI 2011AA)
8619003 (SNOMED CT 2011_0131)
10021926 (MedDRA 14.1)
C0020699 (UMLS CUI 2011AA)
236886002 (SNOMED CT 2011_0131)
10021151 (MedDRA 14.1)
C0232970 (UMLS CUI 2011AA)
76498008 (SNOMED CT 2011_0131)
C0002453 (UMLS CUI 2011AA)
14302001 (SNOMED CT 2011_0131)
10001928 (MedDRA 14.1)
N91.2 (ICD-10-CM Version 2010)
626.0 (ICD-9-CM Version 2011)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
C0009905 (UMLS CUI 2011AA)
59261009 (SNOMED CT 2011_0131)
C0004764 (UMLS CUI 2011AA)
225370004 (SNOMED CT 2011_0131)
C0205173 (UMLS CUI 2011AA)
1305003 (SNOMED CT 2011_0131)
partner using condom and subject using spermicide, diaphragm, intra-uterine device or contraceptive sponge) for 1 month prior to Visit 1 (screening visit) or longer if requested by the investigator. Women of childbearing potential must continue to practice birth control during the study and for at least 2 months after completing the study. Women of childbearing potential must have a negative pregnancy test at screening and Visit 2, 5, 7 and 9.
Item
partner using condom and subject using spermicide, diaphragm, intra-uterine device or contraceptive sponge) for 1 month prior to Visit 1 (screening visit) or longer if requested by the investigator. Women of childbearing potential must continue to practice birth control during the study and for at least 2 months after completing the study. Women of childbearing potential must have a negative pregnancy test at screening and Visit 2, 5, 7 and 9.
boolean
C0682323 (UMLS CUI 2011AA)
262043009 (SNOMED CT 2011_0131)
SIGOTHR (HL7 V3 2006_05)
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C0677582 (UMLS CUI 2011AA)
C0681850 (UMLS CUI 2011AA)
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C0037862 (UMLS CUI 2011AA)
425484006 (SNOMED CT 2011_0131)
C0042241 (UMLS CUI 2011AA)
20359006 (SNOMED CT 2011_0131)
C0021900 (UMLS CUI 2011AA)
268460000 (SNOMED CT 2011_0131)
10022745 (MedDRA 14.1)
C0183461 (UMLS CUI 2011AA)
169529008 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)
C1554196 (UMLS CUI 2011AA)
ENC (HL7 V3 2006_05)
C0205172 (UMLS CUI 2011AA)
242762006 (SNOMED CT 2011_0131)
C1272683 (UMLS CUI 2011AA)
385644000 (SNOMED CT 2011_0131)
CL102947 (UMLS CUI 2011AA)
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0750536 (UMLS CUI 2011AA)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
C0347984 (UMLS CUI 2011AA)
371881003 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0205448 (UMLS CUI 2011AA)
19338005 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C0231290 (UMLS CUI 2011AA)
237679004 (SNOMED CT 2011_0131)
CL421124 (UMLS CUI 2011AA)
C0427780 (UMLS CUI 2011AA)
250425007 (SNOMED CT 2011_0131)
10036574 (MedDRA 14.1)
C1409616 (UMLS CUI 2011AA)
C1554196 (UMLS CUI 2011AA)
ENC (HL7 V3 2006_05)
Uncontrolled (refractory) asthma despite optimal treatment
Item
Uncontrolled (refractory) asthma despite optimal treatment
boolean
C0205318 (UMLS CUI 2011AA)
19032002 (SNOMED CT 2011_0131)
C0205269 (UMLS CUI 2011AA)
20646008 (SNOMED CT 2011_0131)
C0004096 (UMLS CUI 2011AA)
195967001 (SNOMED CT 2011_0131)
10003553 (MedDRA 14.1)
MTHU020815 (LOINC Version 232)
J45 (ICD-10-CM Version 2010)
493 (ICD-9-CM Version 2011)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0521124 (UMLS CUI 2011AA)
65897001 (SNOMED CT 2011_0131)
C2698651 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
subjects will have Global Initiative for Asthma (GINA 2006) clinical features of uncontrolled asthma despite treatment with a minimum dose of 800 µg beclomethasone dipropionate or equivalent inhaled corticosteroid per day plus one or more additional controller i.e. long-acting b-agonist, leukotriene antagonist or theophylline. Oral corticosteroids (not parenteral) as additional treatment at any dose are acceptable. The dose of inhaled and oral corticosteroids must have been stable within 4 weeks preceding Visit 1 (screening visit) and will be expected to remain stable for the duration of the study. If subjects are on single inhaler combination products at Visit 1 (e.g. fluticasone/salmeterol - Advair/Seretide or Symbicort (budesonide/formoterol) SMART) they must receive the two components as two separate inhaler medications for the purpose of the trial. This will facilitate withholding the long-acting b-agonist component before lung function and challenge testing (see Section 9.5.7). The GINA 2006 [14] levels of asthma control and treatment are described in Appendix 3.
Item
subjects will have Global Initiative for Asthma (GINA 2006) clinical features of uncontrolled asthma despite treatment with a minimum dose of 800 µg beclomethasone dipropionate or equivalent inhaled corticosteroid per day plus one or more additional controller i.e. long-acting b-agonist, leukotriene antagonist or theophylline. Oral corticosteroids (not parenteral) as additional treatment at any dose are acceptable. The dose of inhaled and oral corticosteroids must have been stable within 4 weeks preceding Visit 1 (screening visit) and will be expected to remain stable for the duration of the study. If subjects are on single inhaler combination products at Visit 1 (e.g. fluticasone/salmeterol - Advair/Seretide or Symbicort (budesonide/formoterol) SMART) they must receive the two components as two separate inhaler medications for the purpose of the trial. This will facilitate withholding the long-acting b-agonist component before lung function and challenge testing (see Section 9.5.7). The GINA 2006 [14] levels of asthma control and treatment are described in Appendix 3.
boolean
C0681850 (UMLS CUI 2011AA)
C0205318 (UMLS CUI 2011AA)
19032002 (SNOMED CT 2011_0131)
C0205269 (UMLS CUI 2011AA)
20646008 (SNOMED CT 2011_0131)
C0004096 (UMLS CUI 2011AA)
195967001 (SNOMED CT 2011_0131)
10003553 (MedDRA 14.1)
MTHU020815 (LOINC Version 232)
J45 (ICD-10-CM Version 2010)
493 (ICD-9-CM Version 2011)
C0521124 (UMLS CUI 2011AA)
65897001 (SNOMED CT 2011_0131)
C2698651 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
C2348867 (UMLS CUI 2011AA)
C0424093 (UMLS CUI 2011AA)
247756008 (SNOMED CT 2011_0131)
C0004096 (UMLS CUI 2011AA)
195967001 (SNOMED CT 2011_0131)
10003553 (MedDRA 14.1)
MTHU020815 (LOINC Version 232)
J45 (ICD-10-CM Version 2010)
493 (ICD-9-CM Version 2011)
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
C2348519 (UMLS CUI 2011AA)
C1524031 (UMLS CUI 2011AA)
C0178602 (UMLS CUI 2011AA)
260911001 (SNOMED CT 2011_0131)
C0004906 (UMLS CUI 2011AA)
116575004 (SNOMED CT 2011_0131)
MTHU017342 (LOINC Version 232)
CL415123 (UMLS CUI 2011AA)
CL426883 (UMLS CUI 2011AA)
C0001617 (UMLS CUI 2011AA)
79440004 (SNOMED CT 2011_0131)
C0332173 (UMLS CUI 2011AA)
69620002 (SNOMED CT 2011_0131)
C1524062 (UMLS CUI 2011AA)
MTHU013802 (LOINC Version 232)
C2587213 (UMLS CUI 2011AA)
31509003 (SNOMED CT 2011_0131)
C0205166 (UMLS CUI 2011AA)
255511005 (SNOMED CT 2011_0131)
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C0001644 (UMLS CUI 2011AA)
373227004 (SNOMED CT 2011_0131)
C0595726 (UMLS CUI 2011AA)
372517002 (SNOMED CT 2011_0131)
C0039771 (UMLS CUI 2011AA)
372810006 (SNOMED CT 2011_0131)
MTHU004269 (LOINC Version 232)
C1527415 (UMLS CUI 2011AA)
26643006 (SNOMED CT 2011_0131)
_OralRoute (HL7 V3 2006_05)
C0001617 (UMLS CUI 2011AA)
79440004 (SNOMED CT 2011_0131)
C1524062 (UMLS CUI 2011AA)
MTHU013802 (LOINC Version 232)
C0039798 (UMLS CUI 2011AA)
C0178602 (UMLS CUI 2011AA)
260911001 (SNOMED CT 2011_0131)
C0205360 (UMLS CUI 2011AA)
58158008 (SNOMED CT 2011_0131)
MTHU015276 (LOINC Version 232)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1554196 (UMLS CUI 2011AA)
ENC (HL7 V3 2006_05)
C1409616 (UMLS CUI 2011AA)
C0489652 (UMLS CUI 2011AA)
MTHU024501 (LOINC Version 232)
C0681850 (UMLS CUI 2011AA)
C0205171 (UMLS CUI 2011AA)
50607009 (SNOMED CT 2011_0131)
C0021461 (UMLS CUI 2011AA)
334980009 (SNOMED CT 2011_0131)
INH (HL7 V3 2006_05)
C1947911 (UMLS CUI 2011AA)
C1514468 (UMLS CUI 2011AA)
C1554196 (UMLS CUI 2011AA)
ENC (HL7 V3 2006_05)
C0082607 (UMLS CUI 2011AA)
397192001 (SNOMED CT 2011_0131)
C0073992 (UMLS CUI 2011AA)
372515005 (SNOMED CT 2011_0131)
C0965130 (UMLS CUI 2011AA)
C1130494 (UMLS CUI 2011AA)
C1121854 (UMLS CUI 2011AA)
C0054201 (UMLS CUI 2011AA)
395726003 (SNOMED CT 2011_0131)
MTHU017344 (LOINC Version 232)
C0060657 (UMLS CUI 2011AA)
414289007 (SNOMED CT 2011_0131)
C0205448 (UMLS CUI 2011AA)
19338005 (SNOMED CT 2011_0131)
C1705248 (UMLS CUI 2011AA)
C0443299 (UMLS CUI 2011AA)
263869007 (SNOMED CT 2011_0131)
C0021461 (UMLS CUI 2011AA)
334980009 (SNOMED CT 2011_0131)
C0013227 (UMLS CUI 2011AA)
C0024119 (UMLS CUI 2011AA)
23426006 (SNOMED CT 2011_0131)
10025099 (MedDRA 14.1)
MTHU029811 (LOINC Version 232)
C1315011 (UMLS CUI 2011AA)
MTHU000047 (LOINC Version 232)
A forced expiratory volume in 1 second (FEV1) acceptable for AHR challenge tests (>= 60% of predicted normal) on the challenge days.
Item
A forced expiratory volume in 1 second (FEV1) acceptable for AHR challenge tests (>= 60% of predicted normal) on the challenge days.
boolean
CL414841 (UMLS CUI 2011AA)
C1879533 (UMLS CUI 2011AA)
C0085129 (UMLS CUI 2011AA)
195967001 (SNOMED CT 2011_0131)
10066091 (MedDRA 14.1)
C1315011 (UMLS CUI 2011AA)
MTHU000047 (LOINC Version 232)
C0681842 (UMLS CUI 2011AA)
C0205307 (UMLS CUI 2011AA)
17621005 (SNOMED CT 2011_0131)
N (HL7 V3 2006_05)
A provocative concentration of methacholine causing a 20% fall in FEV1 (PC20) <= 4 mg/mL.
Item
A provocative concentration of methacholine causing a 20% fall in FEV1 (PC20) <= 4 mg/mL.
boolean
C0449428 (UMLS CUI 2011AA)
272733003 (SNOMED CT 2011_0131)
C1446561 (UMLS CUI 2011AA)
C0600370 (UMLS CUI 2011AA)
372766003 (SNOMED CT 2011_0131)
C0678227 (UMLS CUI 2011AA)
23981006 (SNOMED CT 2011_0131)
C0547047 (UMLS CUI 2011AA)
260370003 (SNOMED CT 2011_0131)
CL414841 (UMLS CUI 2011AA)
Aged 18-80 years and are ambulatory and able to travel to the clinic.7. A 12-lead electrocardiogram (ECG) with no-clinically significant abnormalities.
Item
Aged 18-80 years and are ambulatory and able to travel to the clinic.7. A 12-lead electrocardiogram (ECG) with no-clinically significant abnormalities.
boolean
C0439841 (UMLS CUI 2011AA)
C0085732 (UMLS CUI 2011AA)
371150009 (SNOMED CT 2011_0131)
C0040802 (UMLS CUI 2011AA)
129018004 (SNOMED CT 2011_0131)
C0442592 (UMLS CUI 2011AA)
257585005 (SNOMED CT 2011_0131)
C2960418 (UMLS CUI 2011AA)
447113005 (SNOMED CT 2011_0131)
C1518422 (UMLS CUI 2011AA)
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
C0750502 (UMLS CUI 2011AA)
386134007 (SNOMED CT 2011_0131)
C1704258 (UMLS CUI 2011AA)
Clinical chemistry, haematology and urinalysis results within the laboratory reference ranges or deemed not clinically significant by the Investigator.
Item
Clinical chemistry, haematology and urinalysis results within the laboratory reference ranges or deemed not clinically significant by the Investigator.
boolean
C0008000 (UMLS CUI 2011AA)
C0200627 (UMLS CUI 2011AA)
33468001 (SNOMED CT 2011_0131)
MTHU008379 (LOINC Version 232)
C0042014 (UMLS CUI 2011AA)
27171005 (SNOMED CT 2011_0131)
10046614 (MedDRA 14.1)
MTHU000144 (LOINC Version 232)
C1274040 (UMLS CUI 2011AA)
79409006 (SNOMED CT 2011_0131)
C0332285 (UMLS CUI 2011AA)
18720000 (SNOMED CT 2011_0131)
C0022877 (UMLS CUI 2011AA)
261904005 (SNOMED CT 2011_0131)
MTHU029808 (LOINC Version 232)
CL415192 (UMLS CUI 2011AA)
CL414906 (UMLS CUI 2011AA)
C1518422 (UMLS CUI 2011AA)
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
C0750502 (UMLS CUI 2011AA)
386134007 (SNOMED CT 2011_0131)
C0022423 (UMLS CUI 2011AA)
61254005 (SNOMED CT 2011_0131)
CL102947 (UMLS CUI 2011AA)
Body weight of <= 130 kg.
Item
Body weight (observable entity)
boolean
C0005910 (UMLS CUI 2011AA)
27113001 (SNOMED CT 2011_0131)
MTHU001885 (LOINC Version 232)
No other clinically significant abnormality on history and clinical examination (see also Exclusion Criteria).
Item
No other clinically significant abnormality on history and clinical examination (see also Exclusion Criteria).
boolean
C1518422 (UMLS CUI 2011AA)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
C0750502 (UMLS CUI 2011AA)
386134007 (SNOMED CT 2011_0131)
C1704258 (UMLS CUI 2011AA)
C0262926 (UMLS CUI 2011AA)
417662000 (SNOMED CT 2011_0131)
MTHU027722 (LOINC Version 232)
C0031809 (UMLS CUI 2011AA)
5880005 (SNOMED CT 2011_0131)
10034986 (MedDRA 14.1)
MTHU028014 (LOINC Version 232)
89.7 (ICD-9-CM Version 2011)
Able to comply with the requirements of the protocol.
Item
Able to comply with the requirements of the protocol.
boolean
C0085732 (UMLS CUI 2011AA)
371150009 (SNOMED CT 2011_0131)
C1321605 (UMLS CUI 2011AA)
405078008 (SNOMED CT 2011_0131)
C1709747 (UMLS CUI 2011AA)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Experienced a severe exacerbation within 28 days preceding Visit 1.
Item
Experienced a severe exacerbation within 28 days preceding Visit 1.
boolean
C0205082 (UMLS CUI 2011AA)
24484000 (SNOMED CT 2011_0131)
C1444749 (UMLS CUI 2011AA)
410661009 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1554196 (UMLS CUI 2011AA)
ENC (HL7 V3 2006_05)
Onset of uncontrolled seasonal allergy symptoms within 28 days preceding Visit 1. Subjects with a history of allergic rhinitis, seasonal allergy or oesophagitis must be optimally controlled and remain on a stable treatment regimen during the study.
Item
Onset of uncontrolled seasonal allergy symptoms within 28 days preceding Visit 1. Subjects with a history of allergic rhinitis, seasonal allergy or oesophagitis must be optimally controlled and remain on a stable treatment regimen during the study.
boolean
C0332162 (UMLS CUI 2011AA)
77374008 (SNOMED CT 2011_0131)
C0205318 (UMLS CUI 2011AA)
19032002 (SNOMED CT 2011_0131)
C0018621 (UMLS CUI 2011AA)
367498001 (SNOMED CT 2011_0131)
10048908 (MedDRA 14.1)
J30.1 (ICD-10-CM Version 2010)
477.0 (ICD-9-CM Version 2011)
C1457887 (UMLS CUI 2011AA)
MTHU021540 (LOINC Version 232)
780-789.99 (ICD-9-CM Version 2011)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1554196 (UMLS CUI 2011AA)
ENC (HL7 V3 2006_05)
C0681850 (UMLS CUI 2011AA)
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C2607914 (UMLS CUI 2011AA)
61582004 (SNOMED CT 2011_0131)
10039085 (MedDRA 14.1)
J30.9 (ICD-10-CM Version 2010)
477.9 (ICD-9-CM Version 2011)
E13303 (CTCAE 1105E)
C0018621 (UMLS CUI 2011AA)
367498001 (SNOMED CT 2011_0131)
10048908 (MedDRA 14.1)
J30.1 (ICD-10-CM Version 2010)
477.0 (ICD-9-CM Version 2011)
C0014868 (UMLS CUI 2011AA)
16761005 (SNOMED CT 2011_0131)
10030216 (MedDRA 14.1)
K20.9 (ICD-10-CM Version 2010)
530.10 (ICD-9-CM Version 2011)
E10687 (CTCAE 1105E)
C2698651 (UMLS CUI 2011AA)
C2587213 (UMLS CUI 2011AA)
31509003 (SNOMED CT 2011_0131)
C0205360 (UMLS CUI 2011AA)
58158008 (SNOMED CT 2011_0131)
MTHU015276 (LOINC Version 232)
CL031856 (UMLS CUI 2011AA)
C0347984 (UMLS CUI 2011AA)
371881003 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
Participation in another study within five half lives or three months of the start of this study, whichever is the longer. This does not apply to methodological or observational studies in which no investigational medicinal product (IMP) was given.
Item
Participation in another study within five half lives or three months of the start of this study, whichever is the longer. This does not apply to methodological or observational studies in which no investigational medicinal product (IMP) was given.
boolean
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0018517 (UMLS CUI 2011AA)
C2825406 (UMLS CUI 2011AA)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
C1518422 (UMLS CUI 2011AA)
CL025718 (UMLS CUI 2011AA)
C0025662 (UMLS CUI 2011AA)
C1518527 (UMLS CUI 2011AA)
C0332197 (UMLS CUI 2011AA)
2667000 (SNOMED CT 2011_0131)
C1517586 (UMLS CUI 2011AA)
C0205476 (UMLS CUI 2011AA)
74188005 (SNOMED CT 2011_0131)
C1514468 (UMLS CUI 2011AA)
Lower respiratory tract infection within six weeks of Visit 1.5.
Item
Lower respiratory tract infection within six weeks of Visit 1.5.
boolean
C0149725 (UMLS CUI 2011AA)
50417007 (SNOMED CT 2011_0131)
10024968 (MedDRA 14.1)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
C1554196 (UMLS CUI 2011AA)
ENC (HL7 V3 2006_05)
Current smokers or ex-smokers with > 10 pack-years (number of pack years = (number of cigarettes per day/20) x number of years smoked, e.g., 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years).
Item
Current smokers or ex-smokers with > 10 pack-years (number of pack years = (number of cigarettes per day/20) x number of years smoked, e.g., 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years).
boolean
C0337664 (UMLS CUI 2011AA)
77176002 (SNOMED CT 2011_0131)
10048880 (MedDRA 14.1)
C0337671 (UMLS CUI 2011AA)
8517006 (SNOMED CT 2011_0131)
10015572 (MedDRA 14.1)
C1277691 (UMLS CUI 2011AA)
315609007 (SNOMED CT 2011_0131)
C0237753 (UMLS CUI 2011AA)
260299005 (SNOMED CT 2011_0131)
MTHU024869 (LOINC Version 232)
C0677453 (UMLS CUI 2011AA)
C0439228 (UMLS CUI 2011AA)
258703001 (SNOMED CT 2011_0131)
D (HL7 V3 2006_05)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
Blood donation (> 550 mL) in the previous two months.
Item
Blood donation (> 550 mL) in the previous two months.
boolean
C0005794 (UMLS CUI 2011AA)
25179006 (SNOMED CT 2011_0131)
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
C0205448 (UMLS CUI 2011AA)
19338005 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
Excessive intake of alcohol (as judged by the Investigator) or evidence of drug or solvent abuse.
Item
Excessive intake of alcohol (as judged by the Investigator) or evidence of drug or solvent abuse.
boolean
C0560219 (UMLS CUI 2011AA)
160592001 (SNOMED CT 2011_0131)
C0022423 (UMLS CUI 2011AA)
61254005 (SNOMED CT 2011_0131)
CL102947 (UMLS CUI 2011AA)
C0332120 (UMLS CUI 2011AA)
18669006 (SNOMED CT 2011_0131)
C0013146 (UMLS CUI 2011AA)
26416006 (SNOMED CT 2011_0131)
10013654 (MedDRA 14.1)
LP36310-8 (LOINC Version 232)
305.90 (ICD-9-CM Version 2011)
C0037638 (UMLS CUI 2011AA)
61010005 (SNOMED CT 2011_0131)
C1328247 (UMLS CUI 2011AA)
417928002 (SNOMED CT 2011_0131)
10000341 (MedDRA 14.1)
Subjects with a physician-diagnosis of any other significant lung disease, including a primary diagnosis of chronic obstructive pulmonary disease or bronchiectasis, or lung cancer, sarcoidosis, tuberculosis, pulmonary fibrosis and cystic fibrosis.
Item
Subjects with a physician-diagnosis of any other significant lung disease, including a primary diagnosis of chronic obstructive pulmonary disease or bronchiectasis, or lung cancer, sarcoidosis, tuberculosis, pulmonary fibrosis and cystic fibrosis.
boolean
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0031831 (UMLS CUI 2011AA)
309343006 (SNOMED CT 2011_0131)
MTHU010489 (LOINC Version 232)
PHYS (HL7 V3 2006_05)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0750502 (UMLS CUI 2011AA)
386134007 (SNOMED CT 2011_0131)
C0024115 (UMLS CUI 2011AA)
19829001 (SNOMED CT 2011_0131)
10025082 (MedDRA 14.1)
J98.4 (ICD-10-CM Version 2010)
C0332257 (UMLS CUI 2011AA)
55919000 (SNOMED CT 2011_0131)
C0801658 (UMLS CUI 2011AA)
18630-4 (LOINC Version 232)
C0024117 (UMLS CUI 2011AA)
13645005 (SNOMED CT 2011_0131)
10009033 (MedDRA 14.1)
J44.9 (ICD-10-CM Version 2010)
496 (ICD-9-CM Version 2011)
C0006267 (UMLS CUI 2011AA)
12295008 (SNOMED CT 2011_0131)
10006445 (MedDRA 14.1)
J47.9 (ICD-10-CM Version 2010)
494 (ICD-9-CM Version 2011)
C0242379 (UMLS CUI 2011AA)
363358000 (SNOMED CT 2011_0131)
10058467 (MedDRA 14.1)
C34.90 (ICD-10-CM Version 2010)
C0036202 (UMLS CUI 2011AA)
31541009 (SNOMED CT 2011_0131)
10039486 (MedDRA 14.1)
D86.9 (ICD-10-CM Version 2010)
135 (ICD-9-CM Version 2011)
C0041296 (UMLS CUI 2011AA)
56717001 (SNOMED CT 2011_0131)
10044755 (MedDRA 14.1)
MTHU020835 (LOINC Version 232)
A15-A19 (ICD-10-CM Version 2010)
010-018.99 (ICD-9-CM Version 2011)
C0034069 (UMLS CUI 2011AA)
51615001 (SNOMED CT 2011_0131)
10037383 (MedDRA 14.1)
J84.1 (ICD-10-CM Version 2010)
E13527 (CTCAE 1105E)
C0010674 (UMLS CUI 2011AA)
190905008 (SNOMED CT 2011_0131)
10011762 (MedDRA 14.1)
MTHU021607 (LOINC Version 232)
E84 (ICD-10-CM Version 2010)
277.0 (ICD-9-CM Version 2011)
Concurrent medication from Visit 1 (screening visit) and for the duration of the study with any of the prohibited medications.
Item
Concurrent medication from Visit 1 (screening visit) and for the duration of the study with any of the prohibited medications.
boolean
C0205420 (UMLS CUI 2011AA)
68405009 (SNOMED CT 2011_0131)
C0013227 (UMLS CUI 2011AA)
C1554196 (UMLS CUI 2011AA)
ENC (HL7 V3 2006_05)
C1409616 (UMLS CUI 2011AA)
C0489652 (UMLS CUI 2011AA)
MTHU024501 (LOINC Version 232)
C0683610 (UMLS CUI 2011AA)
C0013227 (UMLS CUI 2011AA)
Significant, uncontrolled disease including serious psychological disorders, chronic renal failure, uncontrolled hypertension
Item
Significant, uncontrolled disease including serious psychological disorders, chronic renal failure, uncontrolled hypertension
boolean
C0750502 (UMLS CUI 2011AA)
386134007 (SNOMED CT 2011_0131)
C0205318 (UMLS CUI 2011AA)
19032002 (SNOMED CT 2011_0131)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
C0332257 (UMLS CUI 2011AA)
55919000 (SNOMED CT 2011_0131)
C0205404 (UMLS CUI 2011AA)
42745003 (SNOMED CT 2011_0131)
C0004936 (UMLS CUI 2011AA)
74732009 (SNOMED CT 2011_0131)
10037174 (MedDRA 14.1)
F99 (ICD-10-CM Version 2010)
290-319.99 (ICD-9-CM Version 2011)
C0022661 (UMLS CUI 2011AA)
90688005 (SNOMED CT 2011_0131)
10038444 (MedDRA 14.1)
N18.9 (ICD-10-CM Version 2010)
585.6 (ICD-9-CM Version 2011)
C1868885 (UMLS CUI 2011AA)
10066860 (MedDRA 14.1)
systolic blood pressure > 200 mmHg, or diastolic blood pressure > 100 mmHg, heart disease, psoriasis requiring treatment and subjects who have had a heart attack or stroke within the 3 months preceding Visit 1, or who have a known aneurysm.
Item
systolic blood pressure > 200 mmHg, or diastolic blood pressure > 100 mmHg, heart disease, psoriasis requiring treatment and subjects who have had a heart attack or stroke within the 3 months preceding Visit 1, or who have a known aneurysm.
boolean
C0871470 (UMLS CUI 2011AA)
271649006 (SNOMED CT 2011_0131)
C0428883 (UMLS CUI 2011AA)
271650006 (SNOMED CT 2011_0131)
C0018799 (UMLS CUI 2011AA)
56265001 (SNOMED CT 2011_0131)
10061024 (MedDRA 14.1)
I51.9 (ICD-10-CM Version 2010)
429.9 (ICD-9-CM Version 2011)
C0033860 (UMLS CUI 2011AA)
9014002 (SNOMED CT 2011_0131)
10037153 (MedDRA 14.1)
L40 (ICD-10-CM Version 2010)
C1514873 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
C0027051 (UMLS CUI 2011AA)
22298006 (SNOMED CT 2011_0131)
10028596 (MedDRA 14.1)
MTHU035551 (LOINC Version 232)
I21-I22 (ICD-10-CM Version 2010)
410 (ICD-9-CM Version 2011)
E10152 (CTCAE 1105E)
C0038454 (UMLS CUI 2011AA)
230690007 (SNOMED CT 2011_0131)
10042244 (MedDRA 14.1)
I63.9 (ICD-10-CM Version 2010)
E12826 (CTCAE 1105E)
C2825406 (UMLS CUI 2011AA)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1554196 (UMLS CUI 2011AA)
ENC (HL7 V3 2006_05)
C0205309 (UMLS CUI 2011AA)
36692007 (SNOMED CT 2011_0131)
C0002940 (UMLS CUI 2011AA)
432119003 (SNOMED CT 2011_0131)
10002329 (MedDRA 14.1)
I72.9 (ICD-10-CM Version 2010)
442.9 (ICD-9-CM Version 2011)
Onset of uncontrolled seasonal allergy symptoms within 28 days preceding Visit 1. Subjects with a history of allergic rhinitis, seasonal allergy or oesophagitis must be optimally controlled and remain on a stable treatment regimen during the study.
Item
Onset of uncontrolled seasonal allergy symptoms within 28 days preceding Visit 1. Subjects with a history of allergic rhinitis, seasonal allergy or oesophagitis must be optimally controlled and remain on a stable treatment regimen during the study.
boolean
C0332162 (UMLS CUI 2011AA)
77374008 (SNOMED CT 2011_0131)
C0205318 (UMLS CUI 2011AA)
19032002 (SNOMED CT 2011_0131)
C0018621 (UMLS CUI 2011AA)
367498001 (SNOMED CT 2011_0131)
10048908 (MedDRA 14.1)
J30.1 (ICD-10-CM Version 2010)
477.0 (ICD-9-CM Version 2011)
C1457887 (UMLS CUI 2011AA)
MTHU021540 (LOINC Version 232)
780-789.99 (ICD-9-CM Version 2011)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1554196 (UMLS CUI 2011AA)
ENC (HL7 V3 2006_05)
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C2607914 (UMLS CUI 2011AA)
61582004 (SNOMED CT 2011_0131)
10039085 (MedDRA 14.1)
J30.9 (ICD-10-CM Version 2010)
477.9 (ICD-9-CM Version 2011)
E13303 (CTCAE 1105E)
C0018621 (UMLS CUI 2011AA)
367498001 (SNOMED CT 2011_0131)
10048908 (MedDRA 14.1)
J30.1 (ICD-10-CM Version 2010)
477.0 (ICD-9-CM Version 2011)
C0014868 (UMLS CUI 2011AA)
16761005 (SNOMED CT 2011_0131)
10030216 (MedDRA 14.1)
K20.9 (ICD-10-CM Version 2010)
530.10 (ICD-9-CM Version 2011)
E10687 (CTCAE 1105E)
C2698651 (UMLS CUI 2011AA)
C2587213 (UMLS CUI 2011AA)
31509003 (SNOMED CT 2011_0131)
C0205360 (UMLS CUI 2011AA)
58158008 (SNOMED CT 2011_0131)
MTHU015276 (LOINC Version 232)
CL031856 (UMLS CUI 2011AA)
C0489652 (UMLS CUI 2011AA)
MTHU024501 (LOINC Version 232)
Any factor which, in the opinion of the Investigator, would jeopardise the evaluation or safety or be associated with poor adherence to the protocol (i.e. inability to complete study diary, perform PEF measurements).
Item
Any factor which, in the opinion of the Investigator, would jeopardise the evaluation or safety or be associated with poor adherence to the protocol (i.e. inability to complete study diary, perform PEF measurements).
boolean
C0022423 (UMLS CUI 2011AA)
61254005 (SNOMED CT 2011_0131)
CL102947 (UMLS CUI 2011AA)
C0035648 (UMLS CUI 2011AA)
80943009 (SNOMED CT 2011_0131)
MTHU028018 (LOINC Version 232)
C0220825 (UMLS CUI 2011AA)
C0036043 (UMLS CUI 2011AA)
C0332281 (UMLS CUI 2011AA)
47429007 (SNOMED CT 2011_0131)
C0205169 (UMLS CUI 2011AA)
556001 (SNOMED CT 2011_0131)
C0525058 (UMLS CUI 2011AA)
C1299582 (UMLS CUI 2011AA)
371151008 (SNOMED CT 2011_0131)
C1554962 (UMLS CUI 2011AA)
C (HL7 V3 2006_05)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0376660 (UMLS CUI 2011AA)
C1882330 (UMLS CUI 2011AA)
C0030735 (UMLS CUI 2011AA)
10034192 (MedDRA 14.1)
The subject's primary care physician recommends the subject should not take part in the study.
Item
The subject's primary care physician recommends the subject should not take part in the study.
boolean
C0033131, C0017319 (UMLS CUI 2011AA)
446050000, 59058001 (SNOMED CT 2011_0131)
C0034866 (UMLS CUI 2011AA)
MTHU036724 (LOINC Version 232)
RMD (HL7 V3 2006_05)
C0030705 (UMLS CUI 2011AA)
116154003 (SNOMED CT 2011_0131)
C1518422 (UMLS CUI 2011AA)
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
Known hypersensitivity to CAT-354 or its components, to the challenge agents used in the study or to related drugs.
Item
Known hypersensitivity to CAT-354 or its components, to the challenge agents used in the study or to related drugs.
boolean
C0205309 (UMLS CUI 2011AA)
36692007 (SNOMED CT 2011_0131)
C0020517 (UMLS CUI 2011AA)
418634005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0013227 (UMLS CUI 2011AA)
C1705248 (UMLS CUI 2011AA)
C0805586 (UMLS CUI 2011AA)
MTHU005364 (LOINC Version 232)
C1254351 (UMLS CUI 2011AA)
C0445223 (UMLS CUI 2011AA)
262094002 (SNOMED CT 2011_0131)
C0013227 (UMLS CUI 2011AA)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)

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