ID
41471
Descripción
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. In this form (Status, Adverse Events Status) the occurrence of adverse events and the status of COPD is to be documented during the study.
Link
https://clinicaltrials.gov/ct2/show/NCT00784550
Palabras clave
Versiones (1)
- 21/10/20 21/10/20 -
Titular de derechos de autor
GlaxoSmithKline
Subido en
21 de octubre de 2020
DOI
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Licencia
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
Status, Adverse Events Status
- StudyEvent: ODM
Descripción
Status
Alias
- UMLS CUI-1
- C0449438
Descripción
COPD medication during study
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0024117
- UMLS CUI [1,2]
- C0013227
- UMLS CUI [1,3]
- C0008976
- UMLS CUI [1,4]
- C0347984
Descripción
Concomitant medications during study
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0008976
- UMLS CUI [1,3]
- C0347984
Descripción
COPD exacerbation during study
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0740304
- UMLS CUI [1,2]
- C0008976
- UMLS CUI [1,3]
- C0347984
Descripción
Lower respiratory tract infection requiring antibiotics treatment
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0149725
- UMLS CUI [1,2]
- C1514873
- UMLS CUI [1,3]
- C0003232
- UMLS CUI [1,4]
- C0008976
- UMLS CUI [1,5]
- C0347984
Descripción
AE Status
Alias
- UMLS CUI-1
- C0877248
Descripción
Non-serious adverse events during study
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0008976
- UMLS CUI [1,3]
- C0347984
Descripción
Serious adverse event during study
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0008976
- UMLS CUI [1,3]
- C0347984
Similar models
Status, Adverse Events Status
- StudyEvent: ODM
C0013227 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0347984 (UMLS CUI [1,4])
C0008976 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
C0008976 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
C1514873 (UMLS CUI [1,2])
C0003232 (UMLS CUI [1,3])
C0008976 (UMLS CUI [1,4])
C0347984 (UMLS CUI [1,5])
C0008976 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
C0008976 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])