ID

33359

Description

Study ID: 106837 Clinical Study ID: HZA106837 Study Title: A Long-Term, Randomized, Double-Blind, Parallel Group Study of Fluticasone Furoate/GW642444 Inhalation Powder Once-Daily and Fluticasone Furoate Inhalation Powder Once-Daily in Subjects with Asthma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01086384 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone furoate/vilanterol Trade Name: Relvar Study Indication: Asthma

Keywords

Versions (2)
  1. 11/5/18 11/5/18 -
  2. 12/6/18 12/6/18 -
Copyright Holder

GSK group of companies

Uploaded on

December 6, 2018

DOI

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License

Creative Commons BY-NC 3.0
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A Parallel Group Study of Fluticasone Furoate/Vilanterol in Subjects with Asthma - 106837

English

Randomisation Criteria List

1 forms  
Randomisation criteria question
Description

Randomisation criteria question

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

Did the subject meet all of the Randomisation criteria?

Data type

boolean

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0243161
If NO, please select all boxes corresponding to violations of any randomisation criteria
Description

If NO, please select all boxes corresponding to violations of any randomisation criteria

Alias
UMLS CUI-1
C0034656
UMLS CUI-2
C0243161
UMLS CUI-3
C1709750
Inclusion
Description

Inclusion

Alias
UMLS CUI-1
C1512693
1. Evening pre-dose of FEV1 50% to 90% of the predicted normal
Description

1. Evening pre-dose of FEV1 50% to 90% of the predicted normal

Data type

boolean

Alias
UMLS CUI [1,1]
C0439565
UMLS CUI [1,2]
C0587117
UMLS CUI [1,3]
C0748133
UMLS CUI [1,4]
C0205307
2. A documented use of albuterol/salbutamol and/or asthma symptoms on at least 3 of the last 7 consecutive days of the run-in period
Description

2. A documented use of albuterol/salbutamol and/or asthma symptoms on at least 3 of the last 7 consecutive days of the run-in period

Data type

boolean

Alias
UMLS CUI [1,1]
C0001927
UMLS CUI [1,2]
C0004096
UMLS CUI [1,3]
C1457887
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
1. Clinically significant abnormal laboratory tests during Visit 1, which are still abnormal upon repeat analysis and are not believed to be due to disease(s) present. Each investigator will use his/her discretion in determining the clinical significance of the abnormality. When in doubt, GSK, or designee should be notified so that a joint decision can be made.
Description

1. Clinically significant abnormal laboratory tests during Visit 1, which are still abnormal upon repeat analysis and are not believed to be due to disease(s) present. Each investigator will use his/her discretion in determining the clinical significance of the abnormality. When in doubt, GSK, or designee should be notified so that a joint decision can be made.

Data type

boolean

Alias
UMLS CUI [1,1]
C0438215
UMLS CUI [1,2]
C2826293
UMLS CUI [1,3]
C0545082
UMLS CUI [2,1]
C0008961
UMLS CUI [2,2]
C0022423
2. Changes in asthma medication (excluding albuterol/salbutamol inhalation aerosol provided at Visit 1) occuring between Visits 1 and 2
Description

2. Changes in asthma medication (excluding albuterol/salbutamol inhalation aerosol provided at Visit 1) occuring between Visits 1 and 2

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0004096
UMLS CUI [1,3]
C0392747
UMLS CUI [2,1]
C0001927
UMLS CUI [2,2]
C0205535
UMLS CUI [2,3]
C0001712
UMLS CUI [3]
C0545082
3. Occurrence of a culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear during the run-in period that led to a change in asthma management, or, in the opinion of the investigator, is expected to affect the subjects asthma status or the subjects ability to participate in the study
Description

3. Occurrence of a culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear during the run-in period that led to a change in asthma management, or, in the opinion of the investigator, is expected to affect the subjects asthma status or the subjects ability to participate in the study

Data type

boolean

Alias
UMLS CUI [1,1]
C2745955
UMLS CUI [1,2]
C0004623
UMLS CUI [2,1]
C2745955
UMLS CUI [2,2]
C0042769
UMLS CUI [3]
C0041912
UMLS CUI [4]
C0149725
UMLS CUI [5,1]
C0008961
UMLS CUI [5,2]
C0871010
UMLS CUI [6,1]
C0004096
UMLS CUI [6,2]
C0449438
UMLS CUI [7,1]
C0085732
UMLS CUI [7,2]
C2348568
4. Asthma exacerbation requiring in-patient hospitalisation or emergency department visit between Visits 1 and 2
Description

If a subject experiences a severe asthma exacerbation during run-in , they may extend the run-in period to recover from the symptoms and wash-out any prohibited medications.

Data type

boolean

Alias
UMLS CUI [1]
C0349790
UMLS CUI [2]
C0019993
UMLS CUI [3,1]
C3840745
UMLS CUI [3,2]
C0545082
5. Evidence of significant abnormality in the 12-lead ECG performed at Visit 1, as judged by the investigator. Selected specific ECG findings that are considered to be significant and will exclude the subject from study participation include, but are not limited to, the following:
Description

5. Evidence of significant abnormality in the 12-lead ECG performed at Visit 1, as judged by the investigator. Selected specific ECG findings that are considered to be significant and will exclude the subject from study participation include, but are not limited to, the following:

Data type

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1704258
UMLS CUI [2]
C0545082
UMLS CUI [3,1]
C0008961
UMLS CUI [3,2]
C0022423
UMLS CUI [4]
C2348568
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Similar models

Randomisation Criteria List

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Randomisation criteria question
C0034656 (UMLS CUI-1)
C0243161 (UMLS CUI-2)
Did the subject meet all of the Randomisation criteria?
Item
Did the subject meet all of the Randomisation criteria?
boolean
C0034656 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
Item Group
If NO, please select all boxes corresponding to violations of any randomisation criteria
C0034656 (UMLS CUI-1)
C0243161 (UMLS CUI-2)
C1709750 (UMLS CUI-3)
Item Group
Inclusion
C1512693 (UMLS CUI-1)
1. Evening pre-dose of FEV1 50% to 90% of the predicted normal
Item
1. Evening pre-dose of FEV1 50% to 90% of the predicted normal
boolean
C0439565 (UMLS CUI [1,1])
C0587117 (UMLS CUI [1,2])
C0748133 (UMLS CUI [1,3])
C0205307 (UMLS CUI [1,4])
2. A documented use of albuterol/salbutamol and/or asthma symptoms on at least 3 of the last 7 consecutive days of the run-in period
Item
2. A documented use of albuterol/salbutamol and/or asthma symptoms on at least 3 of the last 7 consecutive days of the run-in period
boolean
C0001927 (UMLS CUI [1,1])
C0004096 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
1. Clinically significant abnormal laboratory tests during Visit 1, which are still abnormal upon repeat analysis and are not believed to be due to disease(s) present. Each investigator will use his/her discretion in determining the clinical significance of the abnormality. When in doubt, GSK, or designee should be notified so that a joint decision can be made.
Item
1. Clinically significant abnormal laboratory tests during Visit 1, which are still abnormal upon repeat analysis and are not believed to be due to disease(s) present. Each investigator will use his/her discretion in determining the clinical significance of the abnormality. When in doubt, GSK, or designee should be notified so that a joint decision can be made.
boolean
C0438215 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,3])
C0008961 (UMLS CUI [2,1])
C0022423 (UMLS CUI [2,2])
2. Changes in asthma medication (excluding albuterol/salbutamol inhalation aerosol provided at Visit 1) occuring between Visits 1 and 2
Item
2. Changes in asthma medication (excluding albuterol/salbutamol inhalation aerosol provided at Visit 1) occuring between Visits 1 and 2
boolean
C0013227 (UMLS CUI [1,1])
C0004096 (UMLS CUI [1,2])
C0392747 (UMLS CUI [1,3])
C0001927 (UMLS CUI [2,1])
C0205535 (UMLS CUI [2,2])
C0001712 (UMLS CUI [2,3])
C0545082 (UMLS CUI [3])
3. Occurrence of a culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear during the run-in period that led to a change in asthma management, or, in the opinion of the investigator, is expected to affect the subjects asthma status or the subjects ability to participate in the study
Item
3. Occurrence of a culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear during the run-in period that led to a change in asthma management, or, in the opinion of the investigator, is expected to affect the subjects asthma status or the subjects ability to participate in the study
boolean
C2745955 (UMLS CUI [1,1])
C0004623 (UMLS CUI [1,2])
C2745955 (UMLS CUI [2,1])
C0042769 (UMLS CUI [2,2])
C0041912 (UMLS CUI [3])
C0149725 (UMLS CUI [4])
C0008961 (UMLS CUI [5,1])
C0871010 (UMLS CUI [5,2])
C0004096 (UMLS CUI [6,1])
C0449438 (UMLS CUI [6,2])
C0085732 (UMLS CUI [7,1])
C2348568 (UMLS CUI [7,2])
4. Asthma exacerbation requiring in-patient hospitalisation or emergency department visit between Visits 1 and 2
Item
4. Asthma exacerbation requiring in-patient hospitalisation or emergency department visit between Visits 1 and 2
boolean
C0349790 (UMLS CUI [1])
C0019993 (UMLS CUI [2])
C3840745 (UMLS CUI [3,1])
C0545082 (UMLS CUI [3,2])
Item
5. Evidence of significant abnormality in the 12-lead ECG performed at Visit 1, as judged by the investigator. Selected specific ECG findings that are considered to be significant and will exclude the subject from study participation include, but are not limited to, the following:
text
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0545082 (UMLS CUI [2])
C0008961 (UMLS CUI [3,1])
C0022423 (UMLS CUI [3,2])
C2348568 (UMLS CUI [4])
5. Evidence of significant abnormality in the 12-lead ECG performed at Visit 1, as judged by the investigator. Selected specific ECG findings that are considered to be significant and will exclude the subject from study participation include, but are not limited to, the following:
Code List
5. Evidence of significant abnormality in the 12-lead ECG performed at Visit 1, as judged by the investigator. Selected specific ECG findings that are considered to be significant and will exclude the subject from study participation include, but are not limited to, the following:
CL Item
sinus bradycardia < 45 bpm (1)
CL Item
sinus tachycardia >=110 bpm (2)
CL Item
multifocal atrial tachycardia (wandering atrial pacemaker with rate >100bpm) (3)
CL Item
PR Interval >240 msec (4)
CL Item
Evidence of Mobitz II second or thrid degree atrioventricular (AV) block (5)
CL Item
Pathological Q waves (defined as wide [>0.04 seconds] and deep [>0.4mV (4mm/mV setting)] or 25% of the height of the corresponding R wave, providing the R wave was >0.5mV [5 mm with 10mm/mV setting] appearing in at least two contiguous leads) (6)
CL Item
Evidence of ventricular ectopic couplets, bigemy, trigemy or multifocal premature ventricular complexes (7)
CL Item
QTcF >=450msec or uncorrected QT> 600msecor an ECG that is not suitable for QT measurements (e.g., poor defined termination of the T wave) (8)
CL Item
ST-T wave abnormalities (excluding non-specific ST-T wave abnormalities) (9)
CL Item
Right or left complete bundle branch block (10)
CL Item
Clinically significant conduction abnormalities (e.g., left bundle branch block, Wolff-Parkinson-WHite syndrome) (11)
CL Item
Clinically significant arrhythmias (e.g., atrial fibrillation with rapid ventricular response, ventricular tachycardia) (12)
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