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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01086384
Registration number
NCT01086384
Ethics application status
Date submitted
11/03/2010
Date registered
15/03/2010
Date last updated
24/01/2018
Titles & IDs
Public title
Asthma Exacerbation Study
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Scientific 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
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Secondary ID [1]
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106837
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Asthma
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Condition category
Condition code
Respiratory
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Asthma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Fluticasone Furoate/GW642444
Treatment: Drugs - Fluticasone furoate
Experimental: Fluticasone furoate/GW642444 -
Experimental: fluticasone furoate -
Treatment: Drugs: Fluticasone Furoate/GW642444
Combination inhaled corticosteroid and long-acting beta2-agonist
Treatment: Drugs: Fluticasone furoate
Inhaled corticosteroid
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants With 1 or More Severe Asthma Exacerbations
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Assessment method [1]
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Asthma is a medical condition that causes narrowing of the small airways in the lungs. A severe asthma exacerbation is defined as a deterioration of asthma requiring the use of systemic corticosteroids (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. Only events deemed by the adjudication committee to be severe asthma exacerbations were used in the analysis of severe asthma exacerbations. The time to the first severe asthma exacerbation was analyzed using a Cox proportional hazards regression model, adjusting for Baseline disease severity (Baseline forced expiratory volume in one second [FEV1, maximum amount of air forcefully exhaled in one second]), sex, age, and region.
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Timepoint [1]
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Baseline to Follow-up (up to 76 weeks of treatment)
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Secondary outcome [1]
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Number of Severe Asthma Exacerbations
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Assessment method [1]
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A severe asthma exacerbation is defined as a deterioration of asthma requiring the use of systemic corticosteroids (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. A participant may have had one or more exacerbations.
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Timepoint [1]
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Baseline to Follow-up (up to 76 weeks of treatment)
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Secondary outcome [2]
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Change From Baseline in Evening Pre-dose Trough FEV1 at Week 36
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Assessment method [2]
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Evening pre-dose trough (lowest value) forced expiratory volume in one second (FEV1) was measured using spirometry equipment that met or exceeded the minimal performance recommendations of the American Thoracic Society. FEV1 is a measure of the maximum amount of air forcefully exhaled in one second. Change from Baseline in evening pre-dose FEV1 was analyzed using an Analysis of Covariance (ANCOVA) model with effects due to Baseline FEV1, sex, age, region, and treatment. Change from Baseline was calculated as the Week 36 value minus the Baseline value.
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Timepoint [2]
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Baseline and Week 36
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Eligibility
Key inclusion criteria
- Clinical diagnosis of asthma
- Reversibility FEV1 of twelve percent or greater and two hundred milliliters and
greater approximately ten to forty minutes following two to four inhalations of
albuterol
- FEV1 of fifty to ninety percent of predicted
- Currently using inhaled corticosteroid therapy
- History of one or more asthma exacerbations requiring treatment with oral/systemic
corticosteroids or emergency department visit or in-patient hospitalization in
previous year
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Minimum age
12
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- History of life threatening asthma in previous 5 years (requiring intubation, and/or
associated with hypercapnia, hypoxic seizure or respiratory arrest
- Respiratory infection or oral candidiasis
- - Uncontrolled disease or clinical abnormality
- Allergies
- Taking another investigational medication or prohibited medication
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
22/02/2010
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
15/09/2011
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Sample size
Target
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Accrual to date
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Final
2020
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC
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Recruitment hospital [1]
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GSK Investigational Site - Garran
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GSK Investigational Site - Blacktown
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GSK Investigational Site - Auchenflower
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GSK Investigational Site - Toorak Gardens
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GSK Investigational Site - Clayton
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2606 - Garran
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2148 - Blacktown
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2077 - Hornsby
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4066 - Auchenflower
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5065 - Toorak Gardens
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3168 - Clayton
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Zaporizhia
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
GlaxoSmithKline
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Ethics approval
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Summary
Brief summary
This study will establish the safety as well as demonstrate benefit of the addition of a LABA
to an ICS by utilizing an endpoint (time to first severe asthma exacerbation) that informs on
both safety and efficacy.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01086384
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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GSK Clinical Trials
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Address
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GlaxoSmithKline
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01086384
Download to PDF