ID
41527
Beschreibung
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
Stichworte
Versionen (1)
- 01.11.20 01.11.20 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
1. November 2020
DOI
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Lizenz
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
Beschreibung
COPD Prior concomitant medications
Alias
- UMLS CUI-1
- C2826257
- UMLS CUI-2
- C2347852
- UMLS CUI-3
- C0024117
Beschreibung
[hidden]
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C2348184
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C2826257
- UMLS CUI [1,4]
- C0024117
Beschreibung
(Trade Name preferred)
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2360065
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C2826257
- UMLS CUI [1,4]
- C0024117
Beschreibung
[hidden]
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2826819
- UMLS CUI [1,2]
- C2826257
- UMLS CUI [1,3]
- C0024117
Beschreibung
[hidden]
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2826819
- UMLS CUI [1,2]
- C0871468
- UMLS CUI [1,3]
- C2826257
- UMLS CUI [1,4]
- C0024117
Beschreibung
[hidden]
Datentyp
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
Beschreibung
[hidden]
Datentyp
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
Beschreibung
Time is optional.
Datentyp
partialDatetime
Alias
- UMLS CUI [1,1]
- C2826734
- UMLS CUI [1,2]
- C2826257
- UMLS CUI [1,3]
- C0024117
Beschreibung
Time is optional
Datentyp
date
Alias
- UMLS CUI [1,1]
- C2826744
- UMLS CUI [1,2]
- C2826257
- UMLS CUI [1,3]
- C0024117
Beschreibung
[hidden]
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2826666
- UMLS CUI [1,2]
- C2826257
- UMLS CUI [1,3]
- C0024117
Beschreibung
This item will be calculated by InForm. [hidden]
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0332307
- UMLS CUI [1,3]
- C2826257
- UMLS CUI [1,4]
- C0024117
Beschreibung
COPD concomitant medications
Alias
- UMLS CUI-1
- C2347852
- UMLS CUI-2
- C0024117
Beschreibung
[hidden]
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C2348184
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C0024117
Beschreibung
(Trade Name preferred)
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2360065
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C0024117
Beschreibung
[hidden]
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2826819
- UMLS CUI [1,2]
- C0024117
Beschreibung
[hidden]
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0024117
- UMLS CUI [1,2]
- C2826819
- UMLS CUI [1,3]
- C0871468
Beschreibung
[hidden]
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0024117
- UMLS CUI [1,2]
- C2826819
- UMLS CUI [1,3]
- C1516698
- UMLS CUI [1,4]
- C0805701
Beschreibung
[hidden]
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0024117
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C0805701
- UMLS CUI [1,4]
- C0231175
Beschreibung
This item is conditional
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2826646
- UMLS CUI [1,2]
- C0024117
Beschreibung
This item is conditional
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0024117
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C0439148
Beschreibung
This item is conditional
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2826654
- UMLS CUI [1,2]
- C0024117
Beschreibung
This item is optional
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2826730
- UMLS CUI [1,2]
- C0024117
Beschreibung
Time is optional
Datentyp
partialDatetime
Alias
- UMLS CUI [1,1]
- C2826734
- UMLS CUI [1,2]
- C0024117
Beschreibung
COPD Concomitant medication ongoing
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2826666
- UMLS CUI [1,2]
- C0024117
Beschreibung
Time is optional
Datentyp
partialDatetime
Alias
- UMLS CUI [1,1]
- C2826744
- UMLS CUI [1,2]
- C0024117
Beschreibung
This item is optional
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0024117
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C3469597
- UMLS CUI [1,4]
- C0740304
Beschreibung
Concomitant medications
Alias
- UMLS CUI-1
- C2347852
Beschreibung
[hidden]
Datentyp
integer
Alias
- UMLS CUI [1]
- C2348184
Beschreibung
(Trade Name preferred)
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2360065
- UMLS CUI [1,2]
- C2347852
Beschreibung
[hidden]
Datentyp
text
Alias
- UMLS CUI [1]
- C2826819
Beschreibung
[hidden]
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2826819
- UMLS CUI [1,2]
- C0871468
Beschreibung
[hidden]
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2826819
- UMLS CUI [1,2]
- C1516698
- UMLS CUI [1,3]
- C0805701
Beschreibung
[hidden]
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0805701
- UMLS CUI [1,3]
- C0231175
Beschreibung
This item is optional
Datentyp
text
Alias
- UMLS CUI [1]
- C2826696
Beschreibung
Time is optional
Datentyp
partialDatetime
Alias
- UMLS CUI [1]
- C2826734
Beschreibung
This item is optional
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2826667
- UMLS CUI [1,2]
- C0332152
- UMLS CUI [1,3]
- C2347804
Beschreibung
Concomitant medication ongoing
Datentyp
text
Alias
- UMLS CUI [1]
- C2826666
Beschreibung
Time is optional
Datentyp
partialDatetime
Alias
- UMLS CUI [1]
- C2826744
Beschreibung
This item will be calculated by InForm. [hidden]
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0332307
Ähnliche Modelle
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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