ID

41569

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 (Randomisation, Run-in Failure) is to be filled out at Visit 2 (Randomisation).

Link

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

Stichworte

Versionen (1)
  1. 11.11.20 11.11.20 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

11. 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

Englisch

Randomisation, Run-in Failure

1 Formulare  
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
Randomisation number
Beschreibung

Randomisation number

Alias
UMLS CUI-1
C0034656
UMLS CUI-2
C0237753
Was the subject able to be randomised?
Beschreibung

Randomisation possible

Datentyp

text

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0332149
Randomisation number
Beschreibung

Randomisation number

Datentyp

integer

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
Run-in Failure
Beschreibung

Run-in Failure

Alias
UMLS CUI-1
C1710476
Was this subject a run-in failure?
Beschreibung

Run-in Failure

Datentyp

text

Alias
UMLS CUI [1]
C1710476
Run-in failure date
Beschreibung

Date is optional and should be removed from the prompt when date is not being captured.

Datentyp

date

Alias
UMLS CUI [1,1]
C1710476
UMLS CUI [1,2]
C0011008
Select primary reason
Beschreibung

Primary reason for run-in failure

Datentyp

integer

Alias
UMLS CUI [1,1]
C1710476
UMLS CUI [1,2]
C0566251
If primary reason for run-in failure: Adverse Event, exacerbation of medical condition under investigation?
Beschreibung

Primary reason for run-in failure: Adverse Event, COPD exacerbation under investigation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1710476
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0566251
UMLS CUI [2,1]
C1261322
UMLS CUI [2,2]
C0740304
If primary reason for run-in failure: Investigator discretion, specify
Beschreibung

Primary reason for run-in failure: Investigator discretion

Datentyp

text

Alias
UMLS CUI [1,1]
C1710476
UMLS CUI [1,2]
C0566251
UMLS CUI [1,3]
C0008961
UMLS CUI [1,4]
C0022423
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Ähnliche Modelle

Randomisation, Run-in Failure

1 Formulare
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 Group
Randomisation number
C0034656 (UMLS CUI-1)
C0237753 (UMLS CUI-2)
Item
Was the subject able to be randomised?
text
C0034656 (UMLS CUI [1,1])
C0332149 (UMLS CUI [1,2])
Randomisation possible
Code List
Was the subject able to be randomised?
CL Item
No (N)
CL Item
Yes, provide randomisation number (Y)
Randomisation number
Item
Randomisation number
integer
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Item Group
Run-in Failure
C1710476 (UMLS CUI-1)
Item
Was this subject a run-in failure?
text
C1710476 (UMLS CUI [1])
Run-in Failure
Code List
Was this subject a run-in failure?
CL Item
No (N)
CL Item
Yes, complete run-in failure date and reason (Y)
Run-in failure date
Item
Run-in failure date
date
C1710476 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Select primary reason
integer
C1710476 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
Primary reason for run-in failure
Code List
Select primary reason
CL Item
Adverse Event, check if exacerbation of medical condition is under investigation (1)
CL Item
Lack of efficacy (2)
CL Item
Protocol deviation (3)
CL Item
Lost to follow-up (6)
CL Item
Investigator discretion, specify (7)
CL Item
Withdrew consent (8)
Primary reason for run-in failure: Adverse Event, COPD exacerbation under investigation
Item
If primary reason for run-in failure: Adverse Event, exacerbation of medical condition under investigation?
boolean
C1710476 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
C1261322 (UMLS CUI [2,1])
C0740304 (UMLS CUI [2,2])
Primary reason for run-in failure: Investigator discretion
Item
If primary reason for run-in failure: Investigator discretion, specify
text
C1710476 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C0008961 (UMLS CUI [1,3])
C0022423 (UMLS CUI [1,4])
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