ID

41597

Beschrijving

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 (Smoking Status) is to be filled out at Visit 2, 3, 4, 5 and 6 and/or in case of early withdrawal.

Link

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

Trefwoorden

  1. 19-11-20 19-11-20 -
  2. 19-11-20 19-11-20 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

19 november 2020

DOI

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Licentie

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

Smoking Status

  1. StudyEvent: ODM
    1. Smoking Status
Administrative Data
Beschrijving

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject identification number
Beschrijving

Subject identification number

Datatype

text

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

Date of visit/assessment

Datatype

date

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

Visit type

Datatype

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
Smoking Status
Beschrijving

Smoking Status

Alias
UMLS CUI-1
C1519386
Has the subject smoked since the last visit?
Beschrijving

Smoked since last visit

Datatype

text

Alias
UMLS CUI [1,1]
C0453996
UMLS CUI [1,2]
C1711239
UMLS CUI [1,3]
C0545082
UMLS CUI [1,4]
C1517741

Similar models

Smoking Status

  1. StudyEvent: ODM
    1. Smoking Status
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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
integer
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)
CL Item
Visit 6 (5)
CL Item
Early Withdrawal (6)
Item Group
Smoking Status
C1519386 (UMLS CUI-1)
Item
Has the subject smoked since the last visit?
text
C0453996 (UMLS CUI [1,1])
C1711239 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,3])
C1517741 (UMLS CUI [1,4])
Code List
Has the subject smoked since the last visit?
CL Item
No (N)
CL Item
Yes (Y)

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