ID

35245

Description

Study ID: 102970 Clinical Study ID: 102970 Study Title: A 52-week Efficacy and Safety Study to Compare the Effect of Three Dosage Strengths of Fluticasone Furoate/GW642444 Inhalation Powder With GW642444 on the Annual Rate of Exacerbations in Subjects With Chronic Obstructive Pulmonary Disease (COPD) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01017952 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: GW642444 Inhalation Powder; FF/GW642444 Inhalation Powder Trade Name: Fluticasone Furoate;Fluticasone Propionate;Fluticasone Propionate/Salmeterol;Salmeterol;Vilanterol Study Indication: Pulmonary Disease, Chronic Obstructive

Keywords

Versions (1)
  1. 2/25/19 2/25/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

February 25, 2019

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Creative Commons BY-NC 3.0
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Effect of Fluticasone Furoate/GW642444 Inhalation Powder With GW642444 on Annual Rate of Exacerbations in Subjects with COPD 102970

English

Randomisation

1 forms  
  1. StudyEvent: ODM
    1. Randomisation
Administrative Data
Description

Administrative Data

Site
Description

Study Site

Data type

text

Alias
UMLS CUI [1]
C2825164
Subject
Description

Clinical trial participant

Data type

text

Alias
UMLS CUI [1]
C1997894
Subject No.
Description

Clinical Trial Subject Unique Identifier

Data type

integer

Alias
UMLS CUI [1]
C2348585
Candidiasis Examination
Description

Candidiasis Examination

Alias
UMLS CUI-1
C0006840
UMLS CUI-2
C4321457
Does the subject have clinical evidence of oropharyngeal candidiasis?
Description

Oropharyngeal Candidiasis, Evidence

Data type

boolean

Alias
UMLS CUI [1,1]
C0919659
UMLS CUI [1,2]
C3887511
Was a culture swab taken?
Description

Oropharyngeal Candidiasis, Taking of swab

Data type

boolean

Alias
UMLS CUI [1,1]
C0919659
UMLS CUI [1,2]
C0563454
Result of culture swab
Description

Oropharyngeal Candidiasis, Taking of swab, Result

Data type

text

Alias
UMLS CUI [1,1]
C0919659
UMLS CUI [1,2]
C0563454
UMLS CUI [1,3]
C1274040
Smoking Status
Description

Smoking Status

Alias
UMLS CUI-1
C1519386
Has the smoking status changed since the last time it was assessed?
Description

Smoking Status, Changed status

Data type

boolean

Alias
UMLS CUI [1,1]
C1519386
UMLS CUI [1,2]
C0443172
If yes, Smoking Status
Description

Smoking Status, Changed status

Data type

text

Alias
UMLS CUI [1,1]
C1519386
UMLS CUI [1,2]
C0443172
Date a change was made
Description

Smoking Status, Changed status, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C1519386
UMLS CUI [1,2]
C0443172
UMLS CUI [1,3]
C0011008
Date of Visit/Assessment
Description

Date of Visit/Assessment

Alias
UMLS CUI-1
C1320303
UMLS CUI-2
C2985720
Date of Visit/Assessment
Description

Date of Visit, Assessment Date

Data type

date

Alias
UMLS CUI [1,1]
C1320303
UMLS CUI [1,2]
C2985720
Run-In Failure
Description

Run-In Failure

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

Trial Screen Failure

Data type

boolean

Alias
UMLS CUI [1]
C1710476
Yes, complete run-in failure - reason
Description

Trial Screen Failure, Reason

Data type

text

Alias
UMLS CUI [1,1]
C1710476
UMLS CUI [1,2]
C0566251
Run-in failure date
Description

Trial Screen Failure, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C1710476
UMLS CUI [1,2]
C0011008
Randomisation Question
Description

Randomisation Question

Alias
UMLS CUI-1
C0034656
UMLS CUI-2
C0243161
Did the subject meet all of the Randomisation criteria?
Description

Randomization, Criteria

Data type

boolean

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0243161
Evidence of pneumonia and/or moderate or severe COPD exacerbation at Screening (Visit 1) or during the run-in period Note: Subjects who experience a pneumonia and/or moderate or severe exacerbations during the run-in period must not be randomized at the randomization visit (Visit 2), but may be re-screened at a later time provided the pneumonia and/or COPD exacerbation has resolved prior to the re-screening visit. At the Re-screening Visit, chest x- ray should confirm resolution of pneumonia. The Re- screening Visit must be conducted at least >=14 days following the resolution date of the exacerbation and/or pneumonia and at least 30 days following the last dose of oral corticosteroids (if applicable).
Description

Pneumonia; COPD Exacerbation

Data type

boolean

Alias
UMLS CUI [1]
C0032285
UMLS CUI [2]
C0740304
Abnormal clinically significant laboratory findings in any liver chemistry, hematology, or chemistry tests at Screening (Visit 1) or upon repeat prior to the day of randomization.
Description

Laboratory Procedures, Abnormality

Data type

boolean

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C1704258
Abnormal and clinically significant 12-lead ECG at Screening (Visit 1) or pre-dose (Visit 2). Investigators will be provided with ECG reviews conducted by a centralized independent cardiologist to assist in evaluation of subject eligibility. For this study, an abnormal and clinically significant finding that would preclude a subject from entering the trial is defined as a 12-lead tracing that is interpreted as, but not limited to, any of the following: - Sinus bradycardia <45bpm - Sinus tachycardia >=110bpm - Multifocal atrial tachycardia (wandering atrial pacemaker with rate >100bpm) - PR interval >240msec - Evidence of Mobitz II second degree or third degree atrioventricular (AV) block - Pathological Q waves (defined as wide [>0.04 seconds] and deep [>0.4mV (4mm with 10mm/mV setting)] or >25% of the height of the corresponding R wave, providing the R wave was >0.5mV [5mm with 10mm/mV setting], appearing in at least two contiguous leads. Note: prior evidence (i.e., ECG obtained at least 12 months prior) of pathological QT waves that are unchanged are not exclusionary. - Evidence of ventricular ectopic couplets, bigeminy, trigeminy or multifocal premature ventricular complexes. - QTc(F) >=450msec or uncorrected QT >600msec or an ECG that is unsuitable for QT measurements (e.g., poor defined termination of the T wave) Note: QTc(F) >=450msec or uncorrected QT>600msec should be confirmed by three readings at least 5 minutes apart. -ST-T wave abnormalities (excluding non-specific ST-T wave abnormalities) - Right or left complete bundle branch block -Clinically significant conduction abnormalities (e.g., left bundle branch block, Wolff-Parkinson-White syndrome) - Clinically significant arrhythmias (e.g., atrial fibrillation with rapid ventricular response, ventricular tachycardia) The investigator will determine the medical significance of ECG abnormalities that are not exclusionary a priori and determine if the subject is precluded from entering the study.
Description

12 lead ECG, Abnormality

Data type

boolean

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1704258
Non-compliance: with IVRS diary completion (failure to complete at least 4 of the last 7 consecutive days for all data fields in the diary), run-in medication (failure to be at least 80% compliant), withholding of prohibited medications or keeping clinic visit appointments.
Description

Non-Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0457432
Investigator Signature
Description

Investigator Signature

Alias
UMLS CUI-1
C2346576
Is this casebook ready to sign?
Description

Investigator Signature

Data type

boolean

Alias
UMLS CUI [1]
C2346576
Electronically Transferred Lab Data
Description

Electronically Transferred Lab Data

Alias
UMLS CUI-1
C0022885
Date sample taken
Description

Laboratory Procedures, Sampling, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0011008
Not done
Description

Laboratory Procedures, Sampling, Not done

Data type

boolean

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C1272696
Randomisation Number
Description

Randomisation Number

Alias
UMLS CUI-1
C0034656
UMLS CUI-2
C0237753
Randomisation number
Description

Randomization, Numbers

Data type

integer

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
Date of randomisation
Description

Randomization, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0011008
Liver Events Assessment
Description

Liver Events Assessment

Alias
UMLS CUI-1
C0023884
UMLS CUI-2
C0877248
UMLS CUI-3
C0220825
Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?
Description

Liver, Laboratory Procedures, Stop, Criteria

Data type

boolean

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0022885
UMLS CUI [1,3]
C2746065
UMLS CUI [1,4]
C0243161
Subject Withdrawal Status
Description

Subject Withdrawal Status

Alias
UMLS CUI-1
C0422727
UMLS CUI-2
C0449438
Did the subject withdraw at this visit?
Description

Withdrawal by Subject, Visit

Data type

boolean

Alias
UMLS CUI [1,1]
C1710677
UMLS CUI [1,2]
C0545082
Pre-Dose Vital Signs
Description

Pre-Dose Vital Signs

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0439565
Blood pressure (systolic)
Description

Systolic Pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Blood Pressure (diastolic)
Description

Diastolic blood pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate
Description

Heart rate

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
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Similar models

Randomisation

1 forms
  1. StudyEvent: ODM
    1. Randomisation
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
Study Site
Item
Site
text
C2825164 (UMLS CUI [1])
Clinical trial participant
Item
Subject
text
C1997894 (UMLS CUI [1])
Clinical Trial Subject Unique Identifier
Item
Subject No.
integer
C2348585 (UMLS CUI [1])
Item Group
Candidiasis Examination
C0006840 (UMLS CUI-1)
C4321457 (UMLS CUI-2)
Oropharyngeal Candidiasis, Evidence
Item
Does the subject have clinical evidence of oropharyngeal candidiasis?
boolean
C0919659 (UMLS CUI [1,1])
C3887511 (UMLS CUI [1,2])
Oropharyngeal Candidiasis, Taking of swab
Item
Was a culture swab taken?
boolean
C0919659 (UMLS CUI [1,1])
C0563454 (UMLS CUI [1,2])
Item
Result of culture swab
text
C0919659 (UMLS CUI [1,1])
C0563454 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Oropharyngeal Candidiasis, Taking of swab, Result
Code List
Result of culture swab
CL Item
Negative (1)
CL Item
Positive (2)
CL Item
Not available (3)
Item Group
Smoking Status
C1519386 (UMLS CUI-1)
Smoking Status, Changed status
Item
Has the smoking status changed since the last time it was assessed?
boolean
C1519386 (UMLS CUI [1,1])
C0443172 (UMLS CUI [1,2])
Item
If yes, Smoking Status
text
C1519386 (UMLS CUI [1,1])
C0443172 (UMLS CUI [1,2])
Smoking Status, Changed status
Code List
If yes, Smoking Status
CL Item
Subject started smoking  (1)
CL Item
Subject stopped smoking (2)
Smoking Status, Changed status, Date in time
Item
Date a change was made
date
C1519386 (UMLS CUI [1,1])
C0443172 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item Group
Date of Visit/Assessment
C1320303 (UMLS CUI-1)
C2985720 (UMLS CUI-2)
Date of Visit, Assessment Date
Item
Date of Visit/Assessment
date
C1320303 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
Item Group
Run-In Failure
C1710476 (UMLS CUI-1)
Trial Screen Failure
Item
Was this subject a run-in failure?
boolean
C1710476 (UMLS CUI [1])
Item
Yes, complete run-in failure - reason
text
C1710476 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
Trial Screen Failure, Reason
Code List
Yes, complete run-in failure - reason
CL Item
Did not meet continuation criteria (1)
CL Item
Adverse Event (2)
CL Item
Study closed/terminated (3)
CL Item
Lost to Follow-up (4)
CL Item
Investigator discretion, specify (5)
CL Item
Withdrew consent, specify (6)
Trial Screen Failure, Date in time
Item
Run-in failure date
date
C1710476 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Randomisation Question
C0034656 (UMLS CUI-1)
C0243161 (UMLS CUI-2)
Randomization, Criteria
Item
Did the subject meet all of the Randomisation criteria?
boolean
C0034656 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
Pneumonia; COPD Exacerbation
Item
Evidence of pneumonia and/or moderate or severe COPD exacerbation at Screening (Visit 1) or during the run-in period Note: Subjects who experience a pneumonia and/or moderate or severe exacerbations during the run-in period must not be randomized at the randomization visit (Visit 2), but may be re-screened at a later time provided the pneumonia and/or COPD exacerbation has resolved prior to the re-screening visit. At the Re-screening Visit, chest x- ray should confirm resolution of pneumonia. The Re- screening Visit must be conducted at least >=14 days following the resolution date of the exacerbation and/or pneumonia and at least 30 days following the last dose of oral corticosteroids (if applicable).
boolean
C0032285 (UMLS CUI [1])
C0740304 (UMLS CUI [2])
Laboratory Procedures, Abnormality
Item
Abnormal clinically significant laboratory findings in any liver chemistry, hematology, or chemistry tests at Screening (Visit 1) or upon repeat prior to the day of randomization.
boolean
C0022885 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
12 lead ECG, Abnormality
Item
Abnormal and clinically significant 12-lead ECG at Screening (Visit 1) or pre-dose (Visit 2). Investigators will be provided with ECG reviews conducted by a centralized independent cardiologist to assist in evaluation of subject eligibility. For this study, an abnormal and clinically significant finding that would preclude a subject from entering the trial is defined as a 12-lead tracing that is interpreted as, but not limited to, any of the following: - Sinus bradycardia <45bpm - Sinus tachycardia >=110bpm - Multifocal atrial tachycardia (wandering atrial pacemaker with rate >100bpm) - PR interval >240msec - Evidence of Mobitz II second degree or third degree atrioventricular (AV) block - Pathological Q waves (defined as wide [>0.04 seconds] and deep [>0.4mV (4mm with 10mm/mV setting)] or >25% of the height of the corresponding R wave, providing the R wave was >0.5mV [5mm with 10mm/mV setting], appearing in at least two contiguous leads. Note: prior evidence (i.e., ECG obtained at least 12 months prior) of pathological QT waves that are unchanged are not exclusionary. - Evidence of ventricular ectopic couplets, bigeminy, trigeminy or multifocal premature ventricular complexes. - QTc(F) >=450msec or uncorrected QT >600msec or an ECG that is unsuitable for QT measurements (e.g., poor defined termination of the T wave) Note: QTc(F) >=450msec or uncorrected QT>600msec should be confirmed by three readings at least 5 minutes apart. -ST-T wave abnormalities (excluding non-specific ST-T wave abnormalities) - Right or left complete bundle branch block -Clinically significant conduction abnormalities (e.g., left bundle branch block, Wolff-Parkinson-White syndrome) - Clinically significant arrhythmias (e.g., atrial fibrillation with rapid ventricular response, ventricular tachycardia) The investigator will determine the medical significance of ECG abnormalities that are not exclusionary a priori and determine if the subject is precluded from entering the study.
boolean
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
Non-Compliance
Item
Non-compliance: with IVRS diary completion (failure to complete at least 4 of the last 7 consecutive days for all data fields in the diary), run-in medication (failure to be at least 80% compliant), withholding of prohibited medications or keeping clinic visit appointments.
boolean
C0457432 (UMLS CUI [1])
Item Group
Investigator Signature
C2346576 (UMLS CUI-1)
Investigator Signature
Item
Is this casebook ready to sign?
boolean
C2346576 (UMLS CUI [1])
Item Group
Electronically Transferred Lab Data
C0022885 (UMLS CUI-1)
Laboratory Procedures, Sampling, Date in time
Item
Date sample taken
date
C0022885 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Laboratory Procedures, Sampling, Not done
Item
Not done
boolean
C0022885 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Item Group
Randomisation Number
C0034656 (UMLS CUI-1)
C0237753 (UMLS CUI-2)
Randomization, Numbers
Item
Randomisation number
integer
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Randomization, Date in time
Item
Date of randomisation
date
C0034656 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Liver Events Assessment
C0023884 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
C0220825 (UMLS CUI-3)
Liver, Laboratory Procedures, Stop, Criteria
Item
Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?
boolean
C0023884 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
C2746065 (UMLS CUI [1,3])
C0243161 (UMLS CUI [1,4])
Item Group
Subject Withdrawal Status
C0422727 (UMLS CUI-1)
C0449438 (UMLS CUI-2)
Withdrawal by Subject, Visit
Item
Did the subject withdraw at this visit?
boolean
C1710677 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
Item Group
Pre-Dose Vital Signs
C0518766 (UMLS CUI-1)
C0439565 (UMLS CUI-2)
Systolic Pressure
Item
Blood pressure (systolic)
integer
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
Blood Pressure (diastolic)
integer
C0428883 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
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