ID

41471

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. In this form (Status, Adverse Events Status) the occurrence of adverse events and the status of COPD is to be documented during the study.

Link

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

Keywords

Versions (1)
  1. 10/21/20 10/21/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

October 21, 2020

DOI

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License

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

English

Status, Adverse Events Status

1 forms  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Date of assessment
Description

Date of assessment

Data type

date

Alias
UMLS CUI [1]
C2985720
Subject Identification Number
Description

Subject Identification Number

Data type

text

Alias
UMLS CUI [1]
C2348585
Status
Description

Status

Alias
UMLS CUI-1
C0449438
Were any COPD medications taken by the subject during the study?
Description

COPD medication during study

Data type

text

Alias
UMLS CUI [1,1]
C0024117
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0008976
UMLS CUI [1,4]
C0347984
Were any concomitant medications taken by the subject during the study?
Description

Concomitant medications during study

Data type

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0347984
Did the subject experience a COPD exacerbation during the study?
Description

COPD exacerbation during study

Data type

text

Alias
UMLS CUI [1,1]
C0740304
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0347984
Did the subject experience a lower respiratory tract infection requiring treatment with antibiotics during the study?
Description

Lower respiratory tract infection requiring antibiotics treatment

Data type

text

Alias
UMLS CUI [1,1]
C0149725
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0003232
UMLS CUI [1,4]
C0008976
UMLS CUI [1,5]
C0347984
AE Status
Description

AE Status

Alias
UMLS CUI-1
C0877248
Did the subject experience any non-serious adverse-events during the study?
Description

Non-serious adverse events during study

Data type

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0347984
Did the subject experience a serious adverse event during the study?
Description

Serious adverse event during study

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0347984
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Similar models

Status, Adverse Events Status

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Date of assessment
Item
Date of assessment
date
C2985720 (UMLS CUI [1])
Subject Identification Number
Item
Subject Identification Number
text
C2348585 (UMLS CUI [1])
Item Group
Status
C0449438 (UMLS CUI-1)
Item
Were any COPD medications taken by the subject during the study?
text
C0024117 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0347984 (UMLS CUI [1,4])
COPD medication during study
Code List
Were any COPD medications taken by the subject during the study?
CL Item
No (N)
CL Item
Yes (Y)
Item
Were any concomitant medications taken by the subject during the study?
text
C2347852 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
Concomitant medications during study
Code List
Were any concomitant medications taken by the subject during the study?
CL Item
No (N)
CL Item
Yes (Y)
Item
Did the subject experience a COPD exacerbation during the study?
text
C0740304 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
COPD exacerbation during study
Code List
Did the subject experience a COPD exacerbation during the study?
CL Item
No (N)
CL Item
Yes (Y)
Item
Did the subject experience a lower respiratory tract infection requiring treatment with antibiotics during the study?
text
C0149725 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0003232 (UMLS CUI [1,3])
C0008976 (UMLS CUI [1,4])
C0347984 (UMLS CUI [1,5])
Lower respiratory tract infection requiring antibiotics treatment
Code List
Did the subject experience a lower respiratory tract infection requiring treatment with antibiotics during the study?
CL Item
No (N)
CL Item
Yes (Y)
Item Group
AE Status
C0877248 (UMLS CUI-1)
Item
Did the subject experience any non-serious adverse-events during the study?
text
C1518404 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
Non-serious adverse events during study
Code List
Did the subject experience any non-serious adverse-events during the study?
CL Item
No (N)
CL Item
Yes (Y)
Item
Did the subject experience a serious adverse event during the study?
text
C1519255 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
Serious adverse event during study
Code List
Did the subject experience a serious adverse event during the study?
CL Item
No (N)
CL Item
Yes (Y)
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