ID

41567

Beschrijving

Study ID: 111114 Clinical Study ID: 111114 Study Title: A Randomized, Double-Blind, Parallel-Group, 24-Week Study to Evaluate the Efficacy and Safety of ADVAIR™ DISKUS™ (Fluticasone Propionate/Salmeterol Combination Product 250/50mcg Inhalation Powder) BID Plus Spiriva HandiHaler (Tiotropium Bromide Inhalation Powder 18mcg) QD Versus Spiriva QD Plus Placebo DISKUS BID in Subjects with Chronic Obstructive Pulmonary Disease (COPD) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00784550 https://clinicaltrials.gov/ct2/show/NCT00784550 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: N/A Trade Name: Tiotropium Bromide, Fluticasone Propionate/Salmeterol Study Indication: Pulmonary Disease, Chronic Obstructive The purpose of the study is to determine the efficacy and safety of the combination of ADVAIR DISKUS® 250/50mcg (FLUTICASONE PROPIONATE/SALMETEROL COMBINATION PRODUCT) plus SPIRIVA® HANDIHALER® inhaler 18mcg (TIOTROPIUM) compared to SPIRIVA® HANDIHALER® inhaler 18mcg (TIOTROPIUM) in patients with COPD. There are a total of 6 visits: Screening (Visit 1), Randomization (Visit 2), and after 4 (Visit 3), 8 (Visit 4), 16 (Visit 5) and 24 (Visit 6) weeks of treatment. This form (Pharmacogenetic Research Consent, Saliva Sample Collection) is to be filled out during the study.

Link

https://clinicaltrials.gov/ct2/show/NCT00784550

Trefwoorden

Versies (1)
  1. 11-11-20 11-11-20 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

11 november 2020

DOI

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Licentie

Creative Commons BY-NC 4.0
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Efficacy and Safety of ADVAIR DISKUS Plus Spiriva HandiHaler Versus Spiriva HandiHaler in COPD NCT00784550

Engels

Pharmacogenetic Research Consent, Saliva Sample Collection

1 Formulieren  
Administrative Data
Beschrijving

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject identification number
Beschrijving

Subject identification number

Datatype

text

Alias
UMLS CUI [1]
C2348585
Date of visit/assessment
Beschrijving

Date of visit/assessment

Datatype

date

Alias
UMLS CUI [1]
C1320303
UMLS CUI [2]
C2985720
Pharmacogenetic research consent
Beschrijving

Pharmacogenetic research consent

Has informed consent been obtained for Pax research?
Beschrijving

Informed consent for pharmacogenetic research

Datatype

text

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C2347500
If yes, record Date informed consent obtained for PGx research
Beschrijving

Date informed consent for pharmacogenetics obtained

Datatype

date

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C2347500
UMLS CUI [1,3]
C0011008
If yes, has saliva been collected for PGx research?
Beschrijving

Saliva collection for pharmacogenetic research

Datatype

text

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C0455046
If Saliva has been collected, record date sample taken
Beschrijving

Date Saliva Sample for pharmacogenetic research was collected

Datatype

date

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C0455046
UMLS CUI [1,3]
C0011008
If no informed consent has been obtained, check reason
Beschrijving

Reason for not obtaining informed consent for pharmacogenetic research

Datatype

integer

Alias
UMLS CUI [1,1]
C0566251
UMLS CUI [1,2]
C0021430
UMLS CUI [1,3]
C2347500
UMLS CUI [1,4]
C1882120
If other reason for not obtaining informed consent for pharmacogenetic research, specify
Beschrijving

Other reason for not obtaining informed consent for pharmacogenetic research

Datatype

text

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C2347500
UMLS CUI [1,3]
C1882120
UMLS CUI [1,4]
C0205394
UMLS CUI [1,5]
C0566251
Sample Type
Beschrijving

[hidden] This item will be calculated by InForm

Datatype

text

Alias
UMLS CUI [1]
C2347029
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Similar models

Pharmacogenetic Research Consent, Saliva Sample Collection

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject identification number
Item
Subject identification number
text
C2348585 (UMLS CUI [1])
Date of visit/assessment
Item
Date of visit/assessment
date
C1320303 (UMLS CUI [1])
C2985720 (UMLS CUI [2])
Item
Has informed consent been obtained for Pax research?
text
C0021430 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
Informed consent for pharmacogenetic research
Code List
Has informed consent been obtained for Pax research?
CL Item
Yes (Y)
CL Item
No (N)
Date informed consent for pharmacogenetics obtained
Item
If yes, record Date informed consent obtained for PGx research
date
C0021430 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
If yes, has saliva been collected for PGx research?
text
C2347500 (UMLS CUI [1,1])
C0455046 (UMLS CUI [1,2])
Saliva collection for pharmacogenetic research
Code List
If yes, has saliva been collected for PGx research?
CL Item
No (N)
CL Item
Yes, record date sample taken (Y)
Date Saliva Sample for pharmacogenetic research was collected
Item
If Saliva has been collected, record date sample taken
date
C2347500 (UMLS CUI [1,1])
C0455046 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
If no informed consent has been obtained, check reason
integer
C0566251 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C2347500 (UMLS CUI [1,3])
C1882120 (UMLS CUI [1,4])
Reason for not obtaining informed consent for pharmacogenetic research
Code List
If no informed consent has been obtained, check reason
CL Item
Subject declined (1)
CL Item
Subject not asked by Investigator (2)
CL Item
Other, specify (3)
Other reason for not obtaining informed consent for pharmacogenetic research
Item
If other reason for not obtaining informed consent for pharmacogenetic research, specify
text
C0021430 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
C1882120 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C0566251 (UMLS CUI [1,5])
Sample Type
Item
Sample Type
text
C2347029 (UMLS CUI [1])
Terug naar het begin van de pagina 

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