ID

41566

Beskrivning

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 (Investigational Product) is to be filled out during the study.

Länk

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

Nyckelord

Versioner (1)
  1. 2020-11-11 2020-11-11 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

11 november 2020

DOI

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Licens

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

Engelsk

Investigational Product

1 Formulär  
Administrative Data
Beskrivning

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject identification number
Beskrivning

Subject identification number

Datatyp

text

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

Date of visit/assessment

Datatyp

date

Alias
UMLS CUI [1]
C1320303
UMLS CUI [2]
C2985720
Investigational Product
Beskrivning

Investigational Product

Alias
UMLS CUI-1
C0304229
Open-label treatment
Beskrivning

Open-label treatment

Datatyp

boolean

Alias
UMLS CUI [1]
C3640652
Open label treatment: Start date
Beskrivning

Open label treatment: Start date

Datatyp

date

Alias
UMLS CUI [1,1]
C3640652
UMLS CUI [1,2]
C0808070
Open label treatment: Stop date
Beskrivning

Open label treatment: Stop date

Datatyp

date

Alias
UMLS CUI [1,1]
C3640652
UMLS CUI [1,2]
C0806020
Double-blind diskus
Beskrivning

Double-blind diskus

Datatyp

boolean

Alias
UMLS CUI [1]
C0013072
Double-blind Diskus: Start Date
Beskrivning

Double-blind Diskus: Start Date

Datatyp

date

Alias
UMLS CUI [1,1]
C0013072
UMLS CUI [1,2]
C0808070
Double-blind Diskus: Stop Date
Beskrivning

Double-blind Diskus: Stop Date

Datatyp

date

Alias
UMLS CUI [1,1]
C0013072
UMLS CUI [1,2]
C0806020
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Similar models

Investigational Product

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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
Investigational Product
C0304229 (UMLS CUI-1)
Open-label treatment
Item
Open-label treatment
boolean
C3640652 (UMLS CUI [1])
Open label treatment: Start date
Item
Open label treatment: Start date
date
C3640652 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Open label treatment: Stop date
Item
Open label treatment: Stop date
date
C3640652 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Double-blind diskus
Item
Double-blind diskus
boolean
C0013072 (UMLS CUI [1])
Double-blind Diskus: Start Date
Item
Double-blind Diskus: Start Date
date
C0013072 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Double-blind Diskus: Stop Date
Item
Double-blind Diskus: Stop Date
date
C0013072 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Tillbaka till toppen 

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