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ID
32950
Beschreibung
Study ID: 106827 Clinical Study ID: HZA106827 Study Title: HZA106827:A randomised, double-blind, placebo-controlled (with rescue medication), parallel group multicentre study of Fluticasone Furoate/GW642444 Inhalation Powder and Fluticasone Furoate Inhalation Powder alone in the treatment of persistent asthma in adults and adolescents Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01165138 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone furoate/vilanterol Trade Name: Allermist,Veramyst,Avamys; Relvar Study Indication: Asthma
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Versionen (2)
- 18.11.18 18.11.18 -
- 21.11.18 21.11.18 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
21. November 2018
DOI
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Creative Commons BY-NC 3.0
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Fluticasone Furoate GW642444 Inhalation Powder and Fluticasone Furoate Inhalation Powder alone in the treatment of persistent asthma NCT01165138
Visit Assessments Complete (Visit 2) and Run-In-Failure, Randomisation Criteria, ICS/ LABA Concomitant Medications, Randomisation Number, Investigational Product, Vital Signs, Electronically Transferred Lab Data, Device Use Assessment, Subject Withdrawal Status and Liver Events Assessment(Visit 3)
Ähnliche Modelle
Visit Assessments Complete (Visit 2) and Run-In-Failure, Randomisation Criteria, ICS/ LABA Concomitant Medications, Randomisation Number, Investigational Product, Vital Signs, Electronically Transferred Lab Data, Device Use Assessment, Subject Withdrawal Status and Liver Events Assessment(Visit 3)
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Date of Visit/ Assessment (Visit 2)
C1320303 (UMLS CUI-1)
C2985720 (UMLS CUI-2)
C2985720 (UMLS CUI-2)
Date of Visit/ Assessment
Item
Date of Visit/ Assessment
date
C1320303 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
C2985720 (UMLS CUI [1,2])
Item Group
Completion of Visit Assessments (Visit 2)
C0545082 (UMLS CUI-1)
C0220825 (UMLS CUI-2)
C0205197 (UMLS CUI-3)
C0220825 (UMLS CUI-2)
C0205197 (UMLS CUI-3)
All Visit 2 assessments completed and confirm subject is not a run in failure?
Item
Were all Visit 2 assessments completed as per the protocol and confirm subject is not a run in failure?
boolean
C0545082 (UMLS CUI [1,1])
C0220825 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
C2348563 (UMLS CUI [1,4])
C0681850 (UMLS CUI [2,1])
C1710476 (UMLS CUI [2,2])
C0220825 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
C2348563 (UMLS CUI [1,4])
C0681850 (UMLS CUI [2,1])
C1710476 (UMLS CUI [2,2])
Item
Was this subject a run- in failure?
text
C1710476 (UMLS CUI [1,1])
C0681850 (UMLS CUI [1,2])
C0681850 (UMLS CUI [1,2])
CL Item
No (N)
CL Item
Yes, complete run- in reason (Y)
Item
If this subject was a run- in failure, complete run- in reason.
integer
C1710476 (UMLS CUI [1,1])
C068185 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
C068185 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
CL Item
Adverse Event (Record details on the Non- Serious Adverse Event or Serious Adverse Events forms as appropriate.) (1)
CL Item
Protocol Deviation (3)
CL Item
Study closed/ terminated (5)
CL Item
Lost to Follow- up (6)
CL Item
Investigator discretion, specify (7)
CL Item
Withdrew consent, specify (8)
CL Item
Did not meet continuation criteria (9)
If this subject was a run- in failure because of Investigator descretion, specify.
Item
If this subject was a run- in failure because of Investigator descretion, specify.
text
C1710476 (UMLS CUI [1,1])
C0681850 (UMLS CUI [1,2])
C0008961 (UMLS CUI [2,1])
C0022423 (UMLS CUI [2,2])
C2348235 (UMLS CUI [2,3])
C0681850 (UMLS CUI [1,2])
C0008961 (UMLS CUI [2,1])
C0022423 (UMLS CUI [2,2])
C2348235 (UMLS CUI [2,3])
If this subject was a run- in failure because of Withdrew consent, specify.
Item
If this subject was a run- in failure because of Withdrew consent, specify.
text
C1710476 (UMLS CUI [1,1])
C0681850 (UMLS CUI [1,2])
C1707492 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
C0681850 (UMLS CUI [1,2])
C1707492 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
CL Item
Yes (Y)
Item
Tick or untick this box to require the investigator to sign the case book.
integer
C2346576 (UMLS CUI [1])
Code List
Tick or untick this box to require the investigator to sign the case book.
CL Item
Sign (1)
Item Group
Date of Visit/ Assessment (Visit 3)
C1320303 (UMLS CUI-1)
C2985720 (UMLS CUI-2)
C2985720 (UMLS CUI-2)
Date of Visit/ Assessment
Item
Date of Visit/ Assessment
date
C1320303 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
C2985720 (UMLS CUI [1,2])
Item Group
Randomisation Criteria (Visit 3)
C0034656 (UMLS CUI-1)
C0243161 (UMLS CUI-2)
C0243161 (UMLS CUI-2)
Item
Did the subject meet all of the Randomisation criteria?
text
C0034656 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
C0243161 (UMLS CUI [1,2])
Code List
Did the subject meet all of the Randomisation criteria?
CL Item
Yes (Y)
CL Item
No, please select all boxes corresponding to violations of any randomzation criteria (N)
CL Item
Evening pre- dose FEV1 of between 40% and 90% of their predicted normal at Visit 3. (1)
CL Item
Demonstrated and reported in an eDiary, symptoms of asthma (a score of >=1 on day- time or night- time asthma symptom scores) and/ or daily albuterol/ salbutamol use on >= 4 od the last consecutive days of the run- in period. (2)
CL Item
Subjects recorded the use of run- in asthma controller medication on >= 4 of the last 7 consecutive days of the run- in period (3)
CL Item
Compliance with completion of the Daily Diary reporting defined as completion of all questions on >= 4 of the last 7 consecutive days of the run- in period. (4)
CL Item
Evidence of 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 own discretion in determining the clinical significance of the abnormality. (1)
CL Item
Changes in asthma medication (excluding albuterol/ salbutamol inhalation aerosol provided at Visit 1). (2)
CL Item
Occurence 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 the study. (3)
CL Item
Evidence of significant abnormality in the 12- lead ECG performed at Visit 2 and/ or Visit 3 (in the subsent of subjects undergoing ECGs at Visit 3). 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: (4)
CL Item
- Sinus bradycardia <45bpm (5)
CL Item
110bpm (- Sinus tachycardia >)
CL Item
- Multifocal atrial tachycardia (wandering atrial pacemaker with rate >100bpm) (7)
CL Item
- PR interval >240msec (8)
CL Item
- Evidence of Mobitz II second degree or third degree atrioventricular (AV) block (9)
CL Item
- 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, provicing the R wave was >0.5mV [5mm with 10mm/mV setting], appearing in at least two contiguous leads. (10)
CL Item
Note: prior evidence (i.e., ECG obtained at last 12 months prior) of pathological Q waves that are unchanged are not exclusionary. (11)
CL Item
- Evidence of ventricular ectopic couplets, bigeminy, trigeminy or multifocal premature ventricular complexes. (12)
CL Item
450msec or an ECG that is unsuitable for QT measurements (e.g., poor defined termination of the T wave). Subjects with right bundle branch block should be excluded if the QTc(F) is >= 480msec. (- QTc(F) >)
CL Item
450msec, or >=480 in subjects with right bundle branch block, should be confirmed by three readings at least 5 minutes apart. (Note: QTc(F) >)
CL Item
- ST- T wave abnormalities (excluding non-specific ST- T wave abnormalities) (15)
CL Item
- Bifascicular block (i.e. Complete left bundle branch block [CLBBB] or complete right bundle branch block with concomitant left fascicular block) (16)
CL Item
- Clinically significant conduction abnormalities (e.g.. left bundle branch block, Wollf- Parkinson-White syndrome) (17)
CL Item
- Clinically significant arrhiythmias (e.g., atrial fibrillation with rapid ventricular response, ventricular tachycardia) (18)
CL Item
Evidence of a severe exacerbation, defined as deterioration of asthma requiring the use of systemic corticoidsteroids (tablets, suspension, or injection) for at least 3 days or an in- patient hospitalization or emergency department visit due to asthma that required systemic corticosteroids between Visits 1 and 3. (5)
CL Item
Clinical visual evidence of oral candidiasis at the Randomization Visit (Visit3). (6)
CL Item
Subject is unable to use the inhaler correctly after 3 seperate demonstrations at Randomisation Visit (Visist 3). (7)
Item
Was this subject a run- in failure?
text
C1710476 (UMLS CUI [1,1])
C0681850 (UMLS CUI [1,2])
C0681850 (UMLS CUI [1,2])
CL Item
No (N)
CL Item
Yes, complete run- in reason (Y)
Item
If this subject was a run- in failure, complete run- in reason.
integer
C1710476 (UMLS CUI [1,1])
C068185 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
C068185 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
CL Item
Adverse Event (Record details on the Non- Serious Adverse Event or Serious Adverse Events forms as appropriate.) (1)
CL Item
Protocol Deviation (3)
CL Item
Study closed/ terminated (5)
CL Item
Lost to Follow- up (6)
CL Item
Investigator discretion, specify (7)
CL Item
Withdrew consent, specify (8)
CL Item
Did not meet continuation criteria (9)
If this subject was a run- in failure because of Investigator descretion, specify.
Item
If this subject was a run- in failure because of Investigator descretion, specify.
text
C1710476 (UMLS CUI [1,1])
C0681850 (UMLS CUI [1,2])
C0008961 (UMLS CUI [2,1])
C0022423 (UMLS CUI [2,2])
C2348235 (UMLS CUI [2,3])
C0681850 (UMLS CUI [1,2])
C0008961 (UMLS CUI [2,1])
C0022423 (UMLS CUI [2,2])
C2348235 (UMLS CUI [2,3])
If this subject was a run- in failure because of Withdrew consent, specify.
Item
If this subject was a run- in failure because of Withdrew consent, specify.
text
C1710476 (UMLS CUI [1,1])
C0681850 (UMLS CUI [1,2])
C1707492 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
C0681850 (UMLS CUI [1,2])
C1707492 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
CL Item
Yes (Y)
Item
Tick or untick this box to require the investigator to sign the case book.
integer
C2346576 (UMLS CUI [1])
Code List
Tick or untick this box to require the investigator to sign the case book.
CL Item
Sign (1)
Item Group
ICS/ LABA Concomitant Medications (Visit 3)
C2347852 (UMLS CUI-1)
C3248292 (UMLS CUI-2)
C0001644 (UMLS CUI-3)
C3248292 (UMLS CUI-2)
C0001644 (UMLS CUI-3)
Item
What inhaled corticosteroid regimen was the subject receiving when they entered the study?
integer
C0586793 (UMLS CUI [1])
C2603343 (UMLS CUI [2,1])
C0337095 (UMLS CUI [2,2])
C2603343 (UMLS CUI [2,1])
C0337095 (UMLS CUI [2,2])
Code List
What inhaled corticosteroid regimen was the subject receiving when they entered the study?
CL Item
ICS alone (1)
CL Item
ICS + salmeterol (2)
CL Item
ICS + formoterol (3)
Item
What specific inhaled corticosteroid did the subject take during the run- in period?
integer
C0586793 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
Code List
What specific inhaled corticosteroid did the subject take during the run- in period?
CL Item
Fluticasone proprionate (1)
CL Item
Beclomethasone diproprionate (2)
CL Item
Budenoside (3)
CL Item
Flunisolide (4)
CL Item
Triamcenolone acetonide (5)
CL Item
Mometasone fuorate (6)
CL Item
Ciclesonide (7)
CL Item
Other inhaled corticodsteroid, specify (8)
If other inhaled corticosteroid, specify
Item
If other inhaled corticosteroid, specify.
text
C0586793 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Total ICS Daily Dose During Run- in
Item
Total ICS Daily Dose During Run- in
text
C0586793 (UMLS CUI [1,1])
C2348070 (UMLS CUI [1,2])
C0439810 (UMLS CUI [1,3])
C2348070 (UMLS CUI [1,2])
C0439810 (UMLS CUI [1,3])
Item Group
Randomisation Number (Visit 3)
C0034656 (UMLS CUI-1)
C0237753 (UMLS CUI-2)
C0237753 (UMLS CUI-2)
Randomisation Number
Item
Randomisation Number
text
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
Date of Randomisation
Item
Date of Randomisation
date
C0034656 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Time of PM clinic visit dose
Item
Time of PM clinic visit dose
time
C0008952 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0178602 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Actual date/ time
Item
Actual date/ time
datetime
C1264639 (UMLS CUI [1])
Blood pressure
Item
Blood pressure (systolic/ diastolic)
text
C0005823 (UMLS CUI [1])
CL Item
Supine (1)
CL Item
Sitting (2)
CL Item
Standing (3)
CL Item
Semi- supine (4)
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Temperature
Item
Temperature
float
C0005903 (UMLS CUI [1])
Respiration rate
Item
Respiration rate
integer
C0231832 (UMLS CUI [1])
Calculated Subject position
Item
Calculated Subject position
text
C1262869 (UMLS CUI [1,1])
C0444686 (UMLS CUI [1,2])
C0444686 (UMLS CUI [1,2])
Item Group
Candidiasis Examination (Visit 3)
C0006840 (UMLS CUI-1)
C4321457 (UMLS CUI-2)
C4321457 (UMLS CUI-2)
Oropharyngeal candidiasis
Item
Does the subject have clinical visual evidence of oropharyngeal candidiasis?
boolean
C0919659 (UMLS CUI [1])
Item Group
Electronically transferred lab data (Visit 3)
C0022885 (UMLS CUI-1)
C1320722 (UMLS CUI-2)
C1320722 (UMLS CUI-2)
Urine Cortisol Date sample taken
Item
Urine Cortisol Date sample taken
date
C1302413 (UMLS CUI [1,1])
C0474662 (UMLS CUI [1,2])
C0474662 (UMLS CUI [1,2])
Haem Lab type code
Item
Haem Lab type code
text
C0018941 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,2])
Chem Lab type code
Item
Chem Lab type code
text
C0005774 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,2])
Urin Lab type code
Item
Urin Lab type code
text
C0042014 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,2])
Item Group
Device Use Assessment (Visit 3)
C0699733 (UMLS CUI-1)
C1524063 (UMLS CUI-2)
C0220825 (UMLS CUI-3)
C1524063 (UMLS CUI-2)
C0220825 (UMLS CUI-3)
Did the subject use the device correctly?
Item
Did the subject use the device correctly?
boolean
C0699733 (UMLS CUI [1,1])
C1524063 (UMLS CUI [1,2])
C2349182 (UMLS CUI [1,3])
C1524063 (UMLS CUI [1,2])
C2349182 (UMLS CUI [1,3])
Item
If subject does not use the device correctly, what did subject do incorrectly?
integer
C3544346 (UMLS CUI [1])
Code List
If subject does not use the device correctly, what did subject do incorrectly?
CL Item
Open the device (1)
CL Item
Inhale the device (2)
CL Item
Close the device (3)
Item
If subject does not use the device correctly, record number of times subject required additional instruction.
integer
C3544346 (UMLS CUI [1])
C1442085 (UMLS CUI [2,1])
C1524062 (UMLS CUI [2,2])
C0237753 (UMLS CUI [2,3])
C1442085 (UMLS CUI [2,1])
C1524062 (UMLS CUI [2,2])
C0237753 (UMLS CUI [2,3])
Code List
If subject does not use the device correctly, record number of times subject required additional instruction.
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
>3 (4)
Item Group
Subject Withdrawal Status (Visit 3)
C0422727 (UMLS CUI-1)
C0449438 (UMLS CUI-2)
C0449438 (UMLS CUI-2)
Did the subject withdraw at this visit?
Item
Did the subject withdraw at this visit?
boolean
C1710677 (UMLS CUI [1])
C0545082 (UMLS CUI [2])
C0545082 (UMLS CUI [2])
Item Group
Electronically transferred lab data (Visit 3)
C0022885 (UMLS CUI-1)
C1320722 (UMLS CUI-2)
C1320722 (UMLS CUI-2)
Date Sample(s) Taken
Item
Date Sample(s) Taken
date
C1302413 (UMLS CUI [1])
Haem Lab type code
Item
Haem Lab type code
text
C0018941 (UMLS CUI [1,1])
C0022877 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
C0022877 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
Chem Lab type code
Item
Chem Lab type code
text
C0005774 (UMLS CUI [1,1])
C0022877 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
C0022877 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
Urin Lab type code
Item
Urin Lab type code
text
C0042014 (UMLS CUI [1,1])
C0022877 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
C0022877 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
Item Group
Liver Events Assessment (Visit 3)
C0023884 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
C0220825 (UMLS CUI-3)
C0877248 (UMLS CUI-2)
C0220825 (UMLS CUI-3)
Liver chemistry event for the lab samples collected at this visit
Item
Was there a protocol defined liver chemistry event for the lab samples collected at this visit?
boolean
C0008000 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
C0005834 (UMLS CUI [2,1])
C0545082 (UMLS CUI [2,2])
C0023884 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
C0005834 (UMLS CUI [2,1])
C0545082 (UMLS CUI [2,2])
Item
Specify type of liver chemistry event.
integer
C0008000 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C0023884 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
CL Item
Liver Event Monitoring Criteria (subject has met protocol defined liver event monitoring criteria). Obtain tests as per protocol. (1)
CL Item
Liver Event Stopping Criteria (subject has met protocol defined liver event stopping criteria, has been monitored for the protocol specified time period and continues to meet liver chemistry monitoring criteria). Stop investigational product, complete date stopped on Investigational Product Form and contact GSK within 24 hours of occurence of liver event by phone or fax. NOTE: If the liver event meets the definition of an SAE, the SAE form must be completed in InForm. If InForm is unavailable, the SAE form should be faxed to GSK. (2)