ID
41465
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 (Demography) is to be filled out at the Screening (Visit 1).
Link
https://clinicaltrials.gov/ct2/show/NCT00784550
Keywords
Versions (1)
- 10/20/20 10/20/20 -
Copyright Holder
GlaxoSmithKline
Uploaded on
October 20, 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.
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
Demography
- StudyEvent: ODM
Description
Demography
Alias
- UMLS CUI-1
- C0011298
Description
Date of birth
Data type
date
Alias
- UMLS CUI [1]
- C0421451
Description
Sex
Data type
text
Alias
- UMLS CUI [1]
- C0079399
Description
Ethnicity
Data type
integer
Alias
- UMLS CUI [1]
- C0015031
Description
Geographic Ancestry: African American/African Heritage
Data type
boolean
Alias
- UMLS CUI [1]
- C3841890
- UMLS CUI [2]
- C0085756
- UMLS CUI [3]
- C0027567
Description
Geographic Ancestry: American Indian or Alaskan Native
Data type
boolean
Alias
- UMLS CUI [1]
- C3841890
- UMLS CUI [2]
- C1515945
Description
Geographic Ancestry: Asian - Central/South Asian Heritage
Data type
boolean
Alias
- UMLS CUI [1]
- C3841890
- UMLS CUI [2]
- C0238696
- UMLS CUI [3]
- C1519427
Description
Geographic Ancestry: Asian - East Asian Heritage
Data type
boolean
Alias
- UMLS CUI [1]
- C3841890
- UMLS CUI [2]
- C4540996
Description
Geographic Ancestry: Asian - Japanese Heritage
Data type
boolean
Alias
- UMLS CUI [1]
- C3841890
- UMLS CUI [2]
- C1556094
Description
Geographic Ancestry: Asian - South East Asian Heritage
Data type
boolean
Alias
- UMLS CUI [1]
- C3841890
- UMLS CUI [2]
- C0238697
Description
Geographic Ancestry: Native Hawaiian or Other Pacific Islander
Data type
boolean
Alias
- UMLS CUI [1]
- C3841890
- UMLS CUI [2]
- C1513907
Description
Geographic Ancestry: White - Arabic/North African Heritage
Data type
boolean
Alias
- UMLS CUI [1]
- C3841890
- UMLS CUI [2]
- C0238604
- UMLS CUI [3]
- C2698217
Description
Geographic Ancestry: White - White/Caucasian/European Heritage
Data type
boolean
Alias
- UMLS CUI [1]
- C3841890
- UMLS CUI [2]
- C0043157
- UMLS CUI [3]
- C1535514
Similar models
Demography
- StudyEvent: ODM
C2985720 (UMLS CUI [2])
C0085756 (UMLS CUI [2])
C0027567 (UMLS CUI [3])
C1515945 (UMLS CUI [2])
C0238696 (UMLS CUI [2])
C1519427 (UMLS CUI [3])
C4540996 (UMLS CUI [2])
C1556094 (UMLS CUI [2])
C0238697 (UMLS CUI [2])
C1513907 (UMLS CUI [2])
C0238604 (UMLS CUI [2])
C2698217 (UMLS CUI [3])
C0043157 (UMLS CUI [2])
C1535514 (UMLS CUI [3])