ID
41647
Descrizione
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 (Subject-Completed Rating Scales & Questionnaires) is to be filled out at Visit 2, 4 and 6 and/or in case of Early Withdrawal.
collegamento
https://clinicaltrials.gov/ct2/show/NCT00784550
Keywords
versioni (1)
- 01/12/20 01/12/20 -
Titolare del copyright
GlaxoSmithKline
Caricato su
1 dicembre 2020
DOI
Per favore, per richiedere un accesso.
Licenza
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
Subject-Completed Rating Scales & Questionnaires
- StudyEvent: ODM
Descrizione
Subject-completed Rating Scales & Questionnaires
Alias
- UMLS CUI-1
- C0681889
- UMLS CUI-2
- C0034394
- UMLS CUI-3
- C0030705
- UMLS CUI-4
- C0205197
Descrizione
Chronic Respiratory Questionnaire Self-administered Standardized Activities completed
Tipo di dati
boolean
Alias
- UMLS CUI [1,1]
- C4289790
- UMLS CUI [1,2]
- C0205197
Descrizione
Chronic Respiratory Questionnaire Self-administered Standardized Activities Result
Tipo di dati
text
Alias
- UMLS CUI [1,1]
- C4289790
- UMLS CUI [1,2]
- C1274040
Descrizione
Quick Inventory of Depressive Symptomatology (16-item) (Self-report) (QIDS-SR16) completed
Tipo di dati
boolean
Alias
- UMLS CUI [1,1]
- C4331197
- UMLS CUI [1,2]
- C0205197
Descrizione
Quick Inventory of Depressive Symptomatology (16-item) (Self-report) (QIDS-SR16) Result
Tipo di dati
text
Alias
- UMLS CUI [1,1]
- C4331197
- UMLS CUI [1,2]
- C1274040
Descrizione
Hospital Anxiety And Depression Scale (HADS) completed
Tipo di dati
boolean
Alias
- UMLS CUI [1,1]
- C3539657
- UMLS CUI [1,2]
- C0205197
Descrizione
Hospital Anxiety And Depression Scale (HADS) Result
Tipo di dati
text
Alias
- UMLS CUI [1,1]
- C3539657
- UMLS CUI [1,2]
- C1274040
Similar models
Subject-Completed Rating Scales & Questionnaires
- StudyEvent: ODM
C2985720 (UMLS CUI [2])
C0034394 (UMLS CUI-2)
C0030705 (UMLS CUI-3)
C0205197 (UMLS CUI-4)
C0205197 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,2])