ID
4539
Description
ODM derived from http://clinicaltrials.gov/show/NCT00525512
Link
http://clinicaltrials.gov/show/NCT00525512
Keywords
Versions (3)
- 12/10/13 12/10/13 - Martin Dugas
- 4/14/14 4/14/14 - Julian Varghese
- 9/20/21 9/20/21 -
Uploaded on
December 10, 2013
DOI
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License
Creative Commons BY-NC 3.0 Legacy
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Eligibility NCT00525512 Pulmonary Disease, Chronic Obstructive
Eligibility
- StudyEvent: Eligibility
Description
Ausschlusskriterien
Alias
- UMLS CUI 2011AA
- CL425201
Description
Significant diseases other than COPD such as history of life-threatening pulmonary obstruction, thoracotomy with pulmonary resection, interstitial lung disease, CF, pulmonary thromboembolic disease, clinically evident bronchiectasis, active tuberculosis, or known moderate to severe renal impairment
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0750502
- SNOMED CT 2011_0131
- 386134007
- UMLS CUI 2011AA
- C0012634
- SNOMED CT 2011_0131
- 64572001
- UMLS CUI 2011AA
- CL411789
- 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
- CL421546
- SNOMED CT 2011_0131
- 392521001
- UMLS CUI 2011AA
- C1610642
- SNOMED CT 2011_0131
- 440181000
- UMLS CUI 2011AA
- C0600260
- MedDRA 14.1
- 10025081
- UMLS CUI 2011AA
- C0039991
- SNOMED CT 2011_0131
- 177765008
- MedDRA 14.1
- 10043491
- ICD-9-CM Version 2011
- 34.01
- UMLS CUI 2011AA
- C0396565
- SNOMED CT 2011_0131
- 119746007
- UMLS CUI 2011AA
- C1869044
- MedDRA 14.1
- 20000042
- 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
- UMLS CUI 2011AA
- C2709248
- SNOMED CT 2011_0131
- 264164005
- LOINC Version 232
- MTHU031874
- UMLS CUI 2011AA
- C0040038
- SNOMED CT 2011_0131
- 371039008
- MedDRA 14.1
- 10043566
- ICD-9-CM Version 2011
- 453.9
- CTCAE 1105E
- E13825
- UMLS CUI 2011AA
- C0205210
- SNOMED CT 2011_0131
- 58147004
- UMLS CUI 2011AA
- C0332120
- SNOMED CT 2011_0131
- 18669006
- 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
- C0151332
- SNOMED CT 2011_0131
- 427099000
- MedDRA 14.1
- 10071157
- UMLS CUI 2011AA
- C0205309
- SNOMED CT 2011_0131
- 36692007
- UMLS CUI 2011AA
- C1881878
- UMLS CUI 2011AA
- C0205082
- SNOMED CT 2011_0131
- 24484000
- UMLS CUI 2011AA
- C0341697
- SNOMED CT 2011_0131
- 236423003
- MedDRA 14.1
- 10062237
Description
Clinical history of asthma
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0205210
- SNOMED CT 2011_0131
- 58147004
- UMLS CUI 2011AA
- CL421546
- SNOMED CT 2011_0131
- 392521001
- 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
Description
Use of supplemental oxygen therapy
Data type
boolean
Alias
- UMLS CUI 2011AA
- C1524063
- SNOMED CT 2011_0131
- 260676000
- UMLS CUI 2011AA
- C2348609
- UMLS CUI 2011AA
- CL426373
Description
Respiratory tract infection or COPD exacerbation in the 6 weeks prior to Visit 1 or during the washout period prior to Visit 3 (may randomize 6 weeks after recovery)
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0035243
- SNOMED CT 2011_0131
- 275498002
- MedDRA 14.1
- 10062352
- LOINC Version 232
- MTHU026191
- UMLS CUI 2011AA
- C0740304
- MedDRA 14.1
- 10010953
- UMLS CUI 2011AA
- C0439230
- SNOMED CT 2011_0131
- 258705008
- HL7 V3 2006_05
- WK
- UMLS CUI 2011AA
- C0332152
- SNOMED CT 2011_0131
- 288556008
- UMLS CUI 2011AA
- C1554196
- HL7 V3 2006_05
- ENC
- UMLS CUI 2011AA
- C0347984
- SNOMED CT 2011_0131
- 371881003
- UMLS CUI 2011AA
- C1710661
- UMLS CUI 2011AA
- C0332152
- SNOMED CT 2011_0131
- 288556008
- UMLS CUI 2011AA
- C1554196
- UMLS CUI 2011AA
- C0034656
- UMLS CUI 2011AA
- C0439230
- SNOMED CT 2011_0131
- 258705008
- HL7 V3 2006_05
- WK
- UMLS CUI 2011AA
- C0231290
- SNOMED CT 2011_0131
- 237679004
- UMLS CUI 2011AA
- C2004454
Description
Recent history (<= 12 months) of myocardial infarction
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0332185
- SNOMED CT 2011_0131
- 6493001
- UMLS CUI 2011AA
- CL421546
- SNOMED CT 2011_0131
- 392521001
- 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
- C0439234
- SNOMED CT 2011_0131
- 258707000
- HL7 V3 2006_05
- Y
Description
Unstable or life-threatening cardiac arrhythmia
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0443343
- SNOMED CT 2011_0131
- 263922001
- UMLS CUI 2011AA
- C1610642
- SNOMED CT 2011_0131
- 440181000
- UMLS CUI 2011AA
- C0003811
- SNOMED CT 2011_0131
- 44808001
- MedDRA 14.1
- 10003119
- ICD-9-CM Version 2011
- 427.9
Description
Malignancy treated with radiation therapy or chemotherapy in the last 5 years
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0006826
- SNOMED CT 2011_0131
- 363346000
- MedDRA 14.1
- 10028997
- LOINC Version 232
- MTHU010328
- ICD-10-CM Version 2010
- C00-C96
- UMLS CUI 2011AA
- C0332293
- SNOMED CT 2011_0131
- 28995006
- UMLS CUI 2011AA
- C0034619
- UMLS CUI 2011AA
- C0392920
- SNOMED CT 2011_0131
- 150415003
- UMLS CUI 2011AA
- C0439234
- SNOMED CT 2011_0131
- 258707000
- HL7 V3 2006_05
- Y
Description
Pregnant or nursing women
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0549206
- MedDRA 14.1
- 10036586
- UMLS CUI 2011AA
- C0006147
- MedDRA 14.1
- 10006247
- UMLS CUI 2011AA
- C0043210
- SNOMED CT 2011_0131
- 224526002
Description
Known hypersensitivity to anticholinergic drugs or any component of the study medications
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0205309
- SNOMED CT 2011_0131
- 36692007
- UMLS CUI 2011AA
- C0570982
- SNOMED CT 2011_0131
- 294065003
- UMLS CUI 2011AA
- C0008976
- SNOMED CT 2011_0131
- 110465008
- UMLS CUI 2011AA
- C0552536
- LOINC Version 232
- MTHU002637
Description
Participation in pulmonary or cardiac rehab program within 13 weeks of Visit 1
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0679823
- HL7 V3 2006_05
- PART
- UMLS CUI 2011AA
- C2709248
- SNOMED CT 2011_0131
- 264164005
- LOINC Version 232
- MTHU031874
- UMLS CUI 2011AA
- C1522601
- UMLS CUI 2011AA
- C0034991
- SNOMED CT 2011_0131
- 52052004
- MedDRA 14.1
- 10057374
- UMLS CUI 2011AA
- C0439230
- SNOMED CT 2011_0131
- 258705008
- HL7 V3 2006_05
- WK
- UMLS CUI 2011AA
- C1554196
- HL7 V3 2006_05
- ENC
Description
Estimated life expectancy < 2 years
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0750572
- SNOMED CT 2011_0131
- 414135002
- UMLS CUI 2011AA
- C0023671
- LOINC Version 232
- LP75025-4
- UMLS CUI 2011AA
- C0439234
- SNOMED CT 2011_0131
- 258707000
- HL7 V3 2006_05
- Y
Description
Symptomatic prostatic hyperplasia or bladder neck obstruction
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0231220
- SNOMED CT 2011_0131
- 264931009
- UMLS CUI 2011AA
- C2937421
- SNOMED CT 2011_0131
- 433234005
- MedDRA 14.1
- 10020728
- ICD-10-CM Version 2010
- N40
- ICD-9-CM Version 2011
- 600
- UMLS CUI 2011AA
- C0005694
- SNOMED CT 2011_0131
- 399072004
- MedDRA 14.1
- 10005060
- ICD-10-CM Version 2010
- N32.0
- ICD-9-CM Version 2011
- 596.0
Description
Known narrow-angle glaucoma
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0205309
- SNOMED CT 2011_0131
- 36692007
- UMLS CUI 2011AA
- C0017605
- SNOMED CT 2011_0131
- 392291006
- MedDRA 14.1
- 10002500
Description
Any condition that is contraindicated for exercise
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0348080
- SNOMED CT 2011_0131
- 260905004
- HL7 V3 2006_05
- COND
- UMLS CUI 2011AA
- C1444657
- SNOMED CT 2011_0131
- 410536001
- UMLS CUI 2011AA
- C0015259
- SNOMED CT 2011_0131
- 256235009
- MedDRA 14.1
- 10015634
Description
Orthopaedic, muscular, neurological or cardiac disease that would interfere with regular participation in aerobic exercise or with exercise testing
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0026857
- SNOMED CT 2011_0131
- 928000
- MedDRA 14.1
- 10048592
- UMLS CUI 2011AA
- C0026848
- SNOMED CT 2011_0131
- 129565002
- MedDRA 14.1
- 10028641
- ICD-10-CM Version 2010
- G72.9
- ICD-9-CM Version 2011
- 359.9
- UMLS CUI 2011AA
- C0442874
- SNOMED CT 2011_0131
- 386033004
- MedDRA 14.1
- 10029328
- UMLS CUI 2011AA
- C0018799
- SNOMED CT 2011_0131
- 56265001
- MedDRA 14.1
- 10061024
- UMLS CUI 2011AA
- C0521102
- SNOMED CT 2011_0131
- 78235001
- UMLS CUI 2011AA
- C0205272
- SNOMED CT 2011_0131
- 17854005
- UMLS CUI 2011AA
- C0679823
- HL7 V3 2006_05
- PART
- UMLS CUI 2011AA
- C0001701
- SNOMED CT 2011_0131
- 229072005
- UMLS CUI 2011AA
- C0015259
- SNOMED CT 2011_0131
- 256235009
- MedDRA 14.1
- 10015634
- UMLS CUI 2011AA
- C0039593
Description
Body mass index < 18 kg/m2 or >35 kg/m2 list truncated for space
Data type
boolean
Alias
- UMLS CUI 2011AA
- C1305855
- SNOMED CT 2011_0131
- 140075008
- MedDRA 14.1
- 10005894
- LOINC Version 232
- LP35925-4
- UMLS CUI 2011AA
- C0745732
- UMLS CUI 2011AA
- CL381565
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Eligibility
- StudyEvent: Eligibility
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C1869044 (UMLS CUI 2011AA)
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C0040038 (UMLS CUI 2011AA)
371039008 (SNOMED CT 2011_0131)
10043566 (MedDRA 14.1)
453.9 (ICD-9-CM Version 2011)
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C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
C0332120 (UMLS CUI 2011AA)
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256235009 (SNOMED CT 2011_0131)
10015634 (MedDRA 14.1)
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129565002 (SNOMED CT 2011_0131)
10028641 (MedDRA 14.1)
G72.9 (ICD-10-CM Version 2010)
359.9 (ICD-9-CM Version 2011)
C0442874 (UMLS CUI 2011AA)
386033004 (SNOMED CT 2011_0131)
10029328 (MedDRA 14.1)
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56265001 (SNOMED CT 2011_0131)
10061024 (MedDRA 14.1)
C0521102 (UMLS CUI 2011AA)
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C0205272 (UMLS CUI 2011AA)
17854005 (SNOMED CT 2011_0131)
C0679823 (UMLS CUI 2011AA)
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C0001701 (UMLS CUI 2011AA)
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C0015259 (UMLS CUI 2011AA)
256235009 (SNOMED CT 2011_0131)
10015634 (MedDRA 14.1)
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