ID
41471
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. In this form (Status, Adverse Events Status) the occurrence of adverse events and the status of COPD is to be documented during the study.
Link
https://clinicaltrials.gov/ct2/show/NCT00784550
Keywords
Versions (1)
- 10/21/20 10/21/20 -
Copyright Holder
GlaxoSmithKline
Uploaded on
October 21, 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
Status, Adverse Events Status
- StudyEvent: ODM
Description
Status
Alias
- UMLS CUI-1
- C0449438
Description
COPD medication during study
Data type
text
Alias
- UMLS CUI [1,1]
- C0024117
- UMLS CUI [1,2]
- C0013227
- UMLS CUI [1,3]
- C0008976
- UMLS CUI [1,4]
- C0347984
Description
Concomitant medications during study
Data type
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0008976
- UMLS CUI [1,3]
- C0347984
Description
COPD exacerbation during study
Data type
text
Alias
- UMLS CUI [1,1]
- C0740304
- UMLS CUI [1,2]
- C0008976
- UMLS CUI [1,3]
- C0347984
Description
Lower respiratory tract infection requiring antibiotics treatment
Data type
text
Alias
- UMLS CUI [1,1]
- C0149725
- UMLS CUI [1,2]
- C1514873
- UMLS CUI [1,3]
- C0003232
- UMLS CUI [1,4]
- C0008976
- UMLS CUI [1,5]
- C0347984
Description
AE Status
Alias
- UMLS CUI-1
- C0877248
Description
Non-serious adverse events during study
Data type
text
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0008976
- UMLS CUI [1,3]
- C0347984
Description
Serious adverse event during study
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0008976
- UMLS CUI [1,3]
- C0347984
Similar models
Status, Adverse Events Status
- StudyEvent: ODM
C0013227 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0347984 (UMLS CUI [1,4])
C0008976 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
C0008976 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
C1514873 (UMLS CUI [1,2])
C0003232 (UMLS CUI [1,3])
C0008976 (UMLS CUI [1,4])
C0347984 (UMLS CUI [1,5])
C0008976 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
C0008976 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])