ID

41567

Description

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

Keywords

Versions (1)
  1. 11/11/20 11/11/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

November 11, 2020

DOI

To request one please log in.

License

Creative Commons BY-NC 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Efficacy and Safety of ADVAIR DISKUS Plus Spiriva HandiHaler Versus Spiriva HandiHaler in COPD NCT00784550

English

Pharmacogenetic Research Consent, Saliva Sample Collection

1 forms  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject identification number
Description

Subject identification number

Data type

text

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

Date of visit/assessment

Data type

date

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

Pharmacogenetic research consent

Has informed consent been obtained for Pax research?
Description

Informed consent for pharmacogenetic research

Data type

text

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

Date informed consent for pharmacogenetics obtained

Data type

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?
Description

Saliva collection for pharmacogenetic research

Data type

text

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

Date Saliva Sample for pharmacogenetic research was collected

Data type

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
Description

Reason for not obtaining informed consent for pharmacogenetic research

Data type

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
Description

Other reason for not obtaining informed consent for pharmacogenetic research

Data type

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
Description

[hidden] This item will be calculated by InForm

Data type

text

Alias
UMLS CUI [1]
C2347029
Back to the top of the page

Similar models

Pharmacogenetic Research Consent, Saliva Sample Collection

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial