ID
41561
Beskrivning
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 Smoking History) is to be filled out during the study.
Länk
https://clinicaltrials.gov/ct2/show/NCT00784550
Nyckelord
Versioner (1)
- 2020-11-11 2020-11-11 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
11 november 2020
DOI
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Licens
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 Smoking History
- StudyEvent: ODM
Beskrivning
Duration of COPD
Alias
- UMLS CUI-1
- C0872146
- UMLS CUI-2
- C0024117
Beskrivning
History of COPD Exacerbations
Alias
- UMLS CUI-1
- C0740304
- UMLS CUI-2
- C0262926
Beskrivning
If none, enter 0 (zero) 'oral corticosteroids', 'systemic corticosteroids', 'corticosteroids' and/or 'antibiotics' are all acceptable options
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0332185
- UMLS CUI [1,2]
- C0740304
- UMLS CUI [1,3]
- C0449788
- UMLS CUI [1,4]
- C2825233
- UMLS CUI [1,5]
- C0019993
- UMLS CUI [1,6]
- C1611645
- UMLS CUI [2,1]
- C0332185
- UMLS CUI [2,2]
- C0740304
- UMLS CUI [2,3]
- C0449788
- UMLS CUI [2,4]
- C0574135
- UMLS CUI [2,5]
- C0019993
- UMLS CUI [2,6]
- C1611645
- UMLS CUI [3,1]
- C0332185
- UMLS CUI [3,2]
- C0740304
- UMLS CUI [3,3]
- C0449788
- UMLS CUI [3,4]
- C0003232
- UMLS CUI [3,5]
- C0019993
- UMLS CUI [3,6]
- C1611645
Beskrivning
If none, enter 0 (zero)
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0332185
- UMLS CUI [1,2]
- C0740304
- UMLS CUI [1,3]
- C0449788
- UMLS CUI [1,4]
- C1708385
Beskrivning
COPD type
Alias
- UMLS CUI-1
- C0024117
- UMLS CUI-2
- C0332307
Beskrivning
Optional item to be included ONLY for COPD studies and ONLY IF specified in the protocol.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0008677
- UMLS CUI [1,2]
- C0024117
Beskrivning
Optional item to be included ONLY for COPD studies and ONLY IF specified in the protocol.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0024117
- UMLS CUI [1,2]
- C0034067
Beskrivning
Smoking History
Alias
- UMLS CUI-1
- C1519384
Beskrivning
History of tobacco use
Datatyp
integer
Alias
- UMLS CUI [1]
- C0841002
Beskrivning
Average number of cigarettes per day
Datatyp
integer
Måttenheter
- cigarettes per day
Alias
- UMLS CUI [1,1]
- C3694146
- UMLS CUI [1,2]
- C1510992
Beskrivning
Years smoked
Datatyp
integer
Måttenheter
- years
Alias
- UMLS CUI [1]
- C3694955
Beskrivning
This item will be calculated by InForm using the following formula: Average number of cigarettes smoked per day divided by 20 and then multiplied by number of years smoked. Round up/down to nearest integer.
Datatyp
integer
Alias
- UMLS CUI [1]
- C1277691
Beskrivning
[hidden] This item will be calculated by InForm
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0439861
- UMLS CUI [1,2]
- C1524063
- UMLS CUI [1,3]
- C0332307
Similar models
COPD and Smoking History
- StudyEvent: ODM
C2985720 (UMLS CUI [2])
C0024117 (UMLS CUI [1,2])
C0024117 (UMLS CUI [1,2])
C0262926 (UMLS CUI-2)
C0740304 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,3])
C2825233 (UMLS CUI [1,4])
C0019993 (UMLS CUI [1,5])
C1611645 (UMLS CUI [1,6])
C0332185 (UMLS CUI [2,1])
C0740304 (UMLS CUI [2,2])
C0449788 (UMLS CUI [2,3])
C0574135 (UMLS CUI [2,4])
C0019993 (UMLS CUI [2,5])
C1611645 (UMLS CUI [2,6])
C0332185 (UMLS CUI [3,1])
C0740304 (UMLS CUI [3,2])
C0449788 (UMLS CUI [3,3])
C0003232 (UMLS CUI [3,4])
C0019993 (UMLS CUI [3,5])
C1611645 (UMLS CUI [3,6])
C0740304 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,3])
C1708385 (UMLS CUI [1,4])
C0024117 (UMLS CUI [1,2])
C0034067 (UMLS CUI [1,2])
C1510992 (UMLS CUI [1,2])
C1524063 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])