ID
41470
Descrição
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 (Vital Signs) is to be filled out at the Screening (Visit 1).
Link
https://clinicaltrials.gov/ct2/show/NCT00784550
Palavras-chave
Versões (1)
- 21/10/2020 21/10/2020 -
Titular dos direitos
GlaxoSmithKline
Transferido a
21 de outubro de 2020
DOI
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Licença
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
Vital Signs
- StudyEvent: ODM
Descrição
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Descrição
Height
Tipo de dados
integer
Unidades de medida
- cm
Alias
- UMLS CUI [1]
- C0005890
Descrição
Weight
Tipo de dados
float
Unidades de medida
- kg
Alias
- UMLS CUI [1]
- C0005910
Descrição
Item to be calculated as: Weight in kilograms divided by the square of height in meters. BMI cannot be >=40 kg/m^2
Tipo de dados
float
Unidades de medida
- kg/m^2
Alias
- UMLS CUI [1]
- C1305855
Similar models
Vital Signs
- StudyEvent: ODM
C2985720 (UMLS CUI [2])