ID

41568

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 (Modified Medical research council dyspnea scale (MMRC)) is to be filled out at Visit 2 (Randomisation). If MMRC score is < 2 subject should be reported as a Run-in Failure.

Lien

https://clinicaltrials.gov/ct2/show/NCT00784550

Mots-clés

Versions (1)
  1. 11/11/2020 11/11/2020 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

11 novembre 2020

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 4.0
Modèle Commentaires :

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Efficacy and Safety of ADVAIR DISKUS Plus Spiriva HandiHaler Versus Spiriva HandiHaler in COPD NCT00784550

Anglais

Modified Medical Research Council dyspnea scale (MMRC)

1 Formulaires  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject identification number
Description

Subject identification number

Type de données

text

Alias
UMLS CUI [1]
C2348585
Date of visit/assessment
Description

Date of visit/assessment

Type de données

date

Alias
UMLS CUI [1]
C1320303
UMLS CUI [2]
C2985720
Modified Medical Research Council Dyspnea Scale
Description

Modified Medical Research Council Dyspnea Scale

Alias
UMLS CUI-1
C3826977
Indicate the one response that applies
Description

Modified Medical Research Council Dyspnea Scale

Type de données

integer

Alias
UMLS CUI [1]
C3826977
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Similar models

Modified Medical Research Council dyspnea scale (MMRC)

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject identification number
Item
Subject identification number
text
C2348585 (UMLS CUI [1])
Date of visit/assessment
Item
Date of visit/assessment
date
C1320303 (UMLS CUI [1])
C2985720 (UMLS CUI [2])
Item Group
Modified Medical Research Council Dyspnea Scale
C3826977 (UMLS CUI-1)
Item
Indicate the one response that applies
integer
C3826977 (UMLS CUI [1])
MMRC
Code List
Indicate the one response that applies
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
0 (0)
Retour au début de la page 

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