ID
41566
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. This form (Investigational Product) is to be filled out during the study.
Lien
https://clinicaltrials.gov/ct2/show/NCT00784550
Mots-clés
Versions (1)
- 11/11/2020 11/11/2020 -
Détendeur de droits
GlaxoSmithKline
Téléchargé le
11 novembre 2020
DOI
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Licence
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
Investigational Product
- StudyEvent: ODM
Description
Investigational Product
Alias
- UMLS CUI-1
- C0304229
Description
Open-label treatment
Type de données
boolean
Alias
- UMLS CUI [1]
- C3640652
Description
Open label treatment: Start date
Type de données
date
Alias
- UMLS CUI [1,1]
- C3640652
- UMLS CUI [1,2]
- C0808070
Description
Open label treatment: Stop date
Type de données
date
Alias
- UMLS CUI [1,1]
- C3640652
- UMLS CUI [1,2]
- C0806020
Description
Double-blind diskus
Type de données
boolean
Alias
- UMLS CUI [1]
- C0013072
Description
Double-blind Diskus: Start Date
Type de données
date
Alias
- UMLS CUI [1,1]
- C0013072
- UMLS CUI [1,2]
- C0808070
Description
Double-blind Diskus: Stop Date
Type de données
date
Alias
- UMLS CUI [1,1]
- C0013072
- UMLS CUI [1,2]
- C0806020
Similar models
Investigational Product
- StudyEvent: ODM
C2985720 (UMLS CUI [2])
C0808070 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])