ID
41561
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 Smoking History) is to be filled out during the study.
Link
https://clinicaltrials.gov/ct2/show/NCT00784550
Stichworte
Versionen (1)
- 11.11.20 11.11.20 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
11. 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 Smoking History
- StudyEvent: ODM
Beschreibung
Duration of COPD
Alias
- UMLS CUI-1
- C0872146
- UMLS CUI-2
- C0024117
Beschreibung
This item is optional
Datentyp
integer
Maßeinheiten
- years
Alias
- UMLS CUI [1,1]
- C0872146
- UMLS CUI [1,2]
- C0024117
Beschreibung
This item is optional
Datentyp
integer
Maßeinheiten
- months
Alias
- UMLS CUI [1,1]
- C0872146
- UMLS CUI [1,2]
- C0024117
Beschreibung
History of COPD Exacerbations
Alias
- UMLS CUI-1
- C0740304
- UMLS CUI-2
- C0262926
Beschreibung
If none, enter 0 (zero) 'oral corticosteroids', 'systemic corticosteroids', 'corticosteroids' and/or 'antibiotics' are all acceptable options
Datentyp
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
Beschreibung
If none, enter 0 (zero)
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0332185
- UMLS CUI [1,2]
- C0740304
- UMLS CUI [1,3]
- C0449788
- UMLS CUI [1,4]
- C1708385
Beschreibung
COPD type
Alias
- UMLS CUI-1
- C0024117
- UMLS CUI-2
- C0332307
Beschreibung
Optional item to be included ONLY for COPD studies and ONLY IF specified in the protocol.
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0008677
- UMLS CUI [1,2]
- C0024117
Beschreibung
Optional item to be included ONLY for COPD studies and ONLY IF specified in the protocol.
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0024117
- UMLS CUI [1,2]
- C0034067
Beschreibung
Smoking History
Alias
- UMLS CUI-1
- C1519384
Beschreibung
History of tobacco use
Datentyp
integer
Alias
- UMLS CUI [1]
- C0841002
Beschreibung
Average number of cigarettes per day
Datentyp
integer
Maßeinheiten
- cigarettes per day
Alias
- UMLS CUI [1,1]
- C3694146
- UMLS CUI [1,2]
- C1510992
Beschreibung
Years smoked
Datentyp
integer
Maßeinheiten
- years
Alias
- UMLS CUI [1]
- C3694955
Beschreibung
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.
Datentyp
integer
Alias
- UMLS CUI [1]
- C1277691
Beschreibung
[hidden] This item will be calculated by InForm
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0439861
- UMLS CUI [1,2]
- C1524063
- UMLS CUI [1,3]
- C0332307
Ähnliche Modelle
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])