ID

41596

Beschreibung

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 (IP Container) is to be filled out at Visit 2, 3, 4 and 5. Record the identifying number from the investigational product container dispensed at each visit. Record once at Visits 2 and 3 and twice at Visits 4 and 5.

Link

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

Stichworte

  1. 19.11.20 19.11.20 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

19. November 2020

DOI

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Lizenz

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

IP Container

  1. StudyEvent: ODM
    1. IP Container
Administrative Data
Beschreibung

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject identification number
Beschreibung

Subject identification number

Datentyp

text

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

Date of visit/assessment

Datentyp

date

Alias
UMLS CUI [1]
C1320303
UMLS CUI [2]
C2985720
Visit type
Beschreibung

Visit type

Datentyp

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
IP Container
Beschreibung

IP Container

Alias
UMLS CUI-1
C3898691
UMLS CUI-2
C0180098
Investigational Product Container Number
Beschreibung

To be filled out once at visits 2 and 3 each and twice at visits 4 and 5.

Datentyp

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0180098
UMLS CUI [1,3]
C0600091

Ähnliche Modelle

IP Container

  1. StudyEvent: ODM
    1. IP Container
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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
Visit type
text
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Code List
Visit type
CL Item
Visit 2 (1)
CL Item
Visit 3 (2)
CL Item
Visit 4 (3)
CL Item
Visit 5 (4)
Item Group
IP Container
C3898691 (UMLS CUI-1)
C0180098 (UMLS CUI-2)
Investigational Product Container Number
Item
Investigational Product Container Number
text
C0304229 (UMLS CUI [1,1])
C0180098 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])

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