ID
41527
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 (COPD and concomitant medication) is to be filled out continuously during the study whenever applicable.
Link
https://clinicaltrials.gov/ct2/show/NCT00784550
Trefwoorden
Versies (1)
- 01-11-20 01-11-20 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
1 november 2020
DOI
Voor een aanvraag inloggen.
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
COPD and concomitant medication
- StudyEvent: ODM
Beschrijving
COPD Prior concomitant medications
Alias
- UMLS CUI-1
- C2826257
- UMLS CUI-2
- C2347852
- UMLS CUI-3
- C0024117
Beschrijving
[hidden]
Datatype
integer
Alias
- UMLS CUI [1,1]
- C2348184
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C2826257
- UMLS CUI [1,4]
- C0024117
Beschrijving
(Trade Name preferred)
Datatype
text
Alias
- UMLS CUI [1,1]
- C2360065
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C2826257
- UMLS CUI [1,4]
- C0024117
Beschrijving
[hidden]
Datatype
text
Alias
- UMLS CUI [1,1]
- C2826819
- UMLS CUI [1,2]
- C2826257
- UMLS CUI [1,3]
- C0024117
Beschrijving
[hidden]
Datatype
text
Alias
- UMLS CUI [1,1]
- C2826819
- UMLS CUI [1,2]
- C0871468
- UMLS CUI [1,3]
- C2826257
- UMLS CUI [1,4]
- C0024117
Beschrijving
[hidden]
Datatype
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C2826257
- UMLS CUI [1,3]
- C0024117
- UMLS CUI [1,4]
- C1516698
- UMLS CUI [1,5]
- C0805701
Beschrijving
[hidden]
Datatype
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C2826257
- UMLS CUI [1,3]
- C0024117
- UMLS CUI [1,4]
- C0805701
- UMLS CUI [1,5]
- C0231175
Beschrijving
Time is optional.
Datatype
partialDatetime
Alias
- UMLS CUI [1,1]
- C2826734
- UMLS CUI [1,2]
- C2826257
- UMLS CUI [1,3]
- C0024117
Beschrijving
Time is optional
Datatype
date
Alias
- UMLS CUI [1,1]
- C2826744
- UMLS CUI [1,2]
- C2826257
- UMLS CUI [1,3]
- C0024117
Beschrijving
[hidden]
Datatype
text
Alias
- UMLS CUI [1,1]
- C2826666
- UMLS CUI [1,2]
- C2826257
- UMLS CUI [1,3]
- C0024117
Beschrijving
This item will be calculated by InForm. [hidden]
Datatype
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0332307
- UMLS CUI [1,3]
- C2826257
- UMLS CUI [1,4]
- C0024117
Beschrijving
COPD concomitant medications
Alias
- UMLS CUI-1
- C2347852
- UMLS CUI-2
- C0024117
Beschrijving
[hidden]
Datatype
integer
Alias
- UMLS CUI [1,1]
- C2348184
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C0024117
Beschrijving
(Trade Name preferred)
Datatype
text
Alias
- UMLS CUI [1,1]
- C2360065
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C0024117
Beschrijving
[hidden]
Datatype
text
Alias
- UMLS CUI [1,1]
- C2826819
- UMLS CUI [1,2]
- C0024117
Beschrijving
[hidden]
Datatype
text
Alias
- UMLS CUI [1,1]
- C0024117
- UMLS CUI [1,2]
- C2826819
- UMLS CUI [1,3]
- C0871468
Beschrijving
[hidden]
Datatype
text
Alias
- UMLS CUI [1,1]
- C0024117
- UMLS CUI [1,2]
- C2826819
- UMLS CUI [1,3]
- C1516698
- UMLS CUI [1,4]
- C0805701
Beschrijving
[hidden]
Datatype
text
Alias
- UMLS CUI [1,1]
- C0024117
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C0805701
- UMLS CUI [1,4]
- C0231175
Beschrijving
This item is conditional
Datatype
text
Alias
- UMLS CUI [1,1]
- C2826646
- UMLS CUI [1,2]
- C0024117
Beschrijving
This item is conditional
Datatype
text
Alias
- UMLS CUI [1,1]
- C0024117
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C0439148
Beschrijving
This item is conditional
Datatype
text
Alias
- UMLS CUI [1,1]
- C2826654
- UMLS CUI [1,2]
- C0024117
Beschrijving
This item is optional
Datatype
text
Alias
- UMLS CUI [1,1]
- C2826730
- UMLS CUI [1,2]
- C0024117
Beschrijving
Time is optional
Datatype
partialDatetime
Alias
- UMLS CUI [1,1]
- C2826734
- UMLS CUI [1,2]
- C0024117
Beschrijving
COPD Concomitant medication ongoing
Datatype
text
Alias
- UMLS CUI [1,1]
- C2826666
- UMLS CUI [1,2]
- C0024117
Beschrijving
Time is optional
Datatype
partialDatetime
Alias
- UMLS CUI [1,1]
- C2826744
- UMLS CUI [1,2]
- C0024117
Beschrijving
This item is optional
Datatype
text
Alias
- UMLS CUI [1,1]
- C0024117
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C3469597
- UMLS CUI [1,4]
- C0740304
Beschrijving
Concomitant medications
Alias
- UMLS CUI-1
- C2347852
Beschrijving
[hidden]
Datatype
integer
Alias
- UMLS CUI [1]
- C2348184
Beschrijving
(Trade Name preferred)
Datatype
text
Alias
- UMLS CUI [1,1]
- C2360065
- UMLS CUI [1,2]
- C2347852
Beschrijving
[hidden]
Datatype
text
Alias
- UMLS CUI [1]
- C2826819
Beschrijving
[hidden]
Datatype
text
Alias
- UMLS CUI [1,1]
- C2826819
- UMLS CUI [1,2]
- C0871468
Beschrijving
[hidden]
Datatype
text
Alias
- UMLS CUI [1,1]
- C2826819
- UMLS CUI [1,2]
- C1516698
- UMLS CUI [1,3]
- C0805701
Beschrijving
[hidden]
Datatype
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0805701
- UMLS CUI [1,3]
- C0231175
Beschrijving
This item is optional
Datatype
text
Alias
- UMLS CUI [1]
- C2826696
Beschrijving
Time is optional
Datatype
partialDatetime
Alias
- UMLS CUI [1]
- C2826734
Beschrijving
This item is optional
Datatype
text
Alias
- UMLS CUI [1,1]
- C2826667
- UMLS CUI [1,2]
- C0332152
- UMLS CUI [1,3]
- C2347804
Beschrijving
Concomitant medication ongoing
Datatype
text
Alias
- UMLS CUI [1]
- C2826666
Beschrijving
Time is optional
Datatype
partialDatetime
Alias
- UMLS CUI [1]
- C2826744
Beschrijving
This item will be calculated by InForm. [hidden]
Datatype
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0332307
Similar models
COPD and concomitant medication
- StudyEvent: ODM
C2985720 (UMLS CUI [2])
C2347852 (UMLS CUI-2)
C0024117 (UMLS CUI-3)
C2347852 (UMLS CUI [1,2])
C2826257 (UMLS CUI [1,3])
C0024117 (UMLS CUI [1,4])
C2347852 (UMLS CUI [1,2])
C2826257 (UMLS CUI [1,3])
C0024117 (UMLS CUI [1,4])
C2826257 (UMLS CUI [1,2])
C0024117 (UMLS CUI [1,3])
C0871468 (UMLS CUI [1,2])
C2826257 (UMLS CUI [1,3])
C0024117 (UMLS CUI [1,4])
C2826257 (UMLS CUI [1,2])
C0024117 (UMLS CUI [1,3])
C1516698 (UMLS CUI [1,4])
C0805701 (UMLS CUI [1,5])
C2826257 (UMLS CUI [1,2])
C0024117 (UMLS CUI [1,3])
C0805701 (UMLS CUI [1,4])
C0231175 (UMLS CUI [1,5])
C2826257 (UMLS CUI [1,2])
C0024117 (UMLS CUI [1,3])
C2826257 (UMLS CUI [1,2])
C0024117 (UMLS CUI [1,3])
C2826257 (UMLS CUI [1,2])
C0024117 (UMLS CUI [1,3])
C0332307 (UMLS CUI [1,2])
C2826257 (UMLS CUI [1,3])
C0024117 (UMLS CUI [1,4])
C0024117 (UMLS CUI-2)
C2347852 (UMLS CUI [1,2])
C0024117 (UMLS CUI [1,3])
C2347852 (UMLS CUI [1,2])
C0024117 (UMLS CUI [1,3])
C0024117 (UMLS CUI [1,2])
C2826819 (UMLS CUI [1,2])
C0871468 (UMLS CUI [1,3])
C2826819 (UMLS CUI [1,2])
C1516698 (UMLS CUI [1,3])
C0805701 (UMLS CUI [1,4])
C2347852 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
C0231175 (UMLS CUI [1,4])
C0024117 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
C0439148 (UMLS CUI [1,3])
C0024117 (UMLS CUI [1,2])
C0024117 (UMLS CUI [1,2])
C0024117 (UMLS CUI [1,2])
C0024117 (UMLS CUI [1,2])
C0024117 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
C3469597 (UMLS CUI [1,3])
C0740304 (UMLS CUI [1,4])
C2347852 (UMLS CUI [1,2])
C0871468 (UMLS CUI [1,2])
C1516698 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
C0805701 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
C0332152 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,3])
C0332307 (UMLS CUI [1,2])
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