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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Secondary ID [1] 0 0
106837
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Asthma

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With 1 or More Severe Asthma Exacerbations
Timepoint [1] 0 0
Baseline to Follow-up (up to 76 weeks of treatment)
Secondary outcome [1] 0 0
Number of Severe Asthma Exacerbations
Timepoint [1] 0 0
Baseline to Follow-up (up to 76 weeks of treatment)
Secondary outcome [2] 0 0
Change From Baseline in Evening Pre-dose Trough FEV1 at Week 36
Timepoint [2] 0 0
Baseline and Week 36

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
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/02/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/09/2011
Sample size
Target
Accrual to date
Final
2020
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
GSK Investigational Site - Garran
Recruitment hospital [2] 0 0
GSK Investigational Site - Blacktown
Recruitment hospital [3] 0 0
GSK Investigational Site - Hornsby
Recruitment hospital [4] 0 0
GSK Investigational Site - Auchenflower
Recruitment hospital [5] 0 0
GSK Investigational Site - Toorak Gardens
Recruitment hospital [6] 0 0
GSK Investigational Site - Clayton
Recruitment postcode(s) [1] 0 0
2606 - Garran
Recruitment postcode(s) [2] 0 0
2148 - Blacktown
Recruitment postcode(s) [3] 0 0
2077 - Hornsby
Recruitment postcode(s) [4] 0 0
4066 - Auchenflower
Recruitment postcode(s) [5] 0 0
5065 - Toorak Gardens
Recruitment postcode(s) [6] 0 0
3168 - Clayton
Recruitment outside Australia
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Alabama
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Arizona
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Vermont
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Wisconsin
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Argentina
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Buenos Aires
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Entre Ríos
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Santa Fe
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Argentina
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Ciudad Autónoma de Buenos Aires
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Argentina
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Mendoza
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Argentina
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Tucuman
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Germany
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Baden-Wuerttemberg
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Bayern
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Germany
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Hessen
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Germany
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Sachsen
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Berlin
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Germany
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Hamburg
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Japan
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Fukuoka
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Hokkaido
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Kanagawa
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Japan
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Kyoto
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Tokyo
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Wolomin
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Wroclaw
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Romania
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Bucharest
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Craiova
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Romania
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Deva
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Romania
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Pitesti
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Romania
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Sibiu
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Russian Federation
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Barnaul
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Blagoveshchensk
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Chelyabinsk
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Kazan
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Russian Federation
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Krasnodar
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Russian Federation
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Novosibirsk
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Russian Federation
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Penza
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Perm
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Pyatigorsk
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Saint-Petersburg
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Saratov
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St. Petersburg
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Tomsk
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Volgodonsk
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Russian Federation
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Voronezh
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Ukraine
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Dnipropetrovsk
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Ukraine
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Donetsk
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Ukraine
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Kyiv
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Ukraine
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Simferopol
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Ukraine
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Vinnytsia
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Ukraine
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Yalta
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Ukraine
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Zaporizhia

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT01086384
Trial related presentations / publications
O'Byrne PM, Jacques L, Goldfrad C, Kwon N, Perrio M, Yates LJ, Busse WW. Integrated safety and efficacy analysis of once-daily fluticasone furoate for the treatment of asthma. Respir Res. 2016 Nov 24;17(1):157. doi: 10.1186/s12931-016-0473-x.
Gross AS, Goldfrad C, Hozawa S, James MH, Clifton CS, Sugiyama Y, Jacques L. Ethnic sensitivity assessment of fluticasone furoate/vilanterol in East Asian asthma patients from randomized double-blind multicentre Phase IIb/III trials. BMC Pulm Med. 2015 Dec 24;15:165. doi: 10.1186/s12890-015-0159-z.
Bateman ED, O'Byrne PM, Busse WW, Lotvall J, Bleecker ER, Andersen L, Jacques L, Frith L, Lim J, Woodcock A. Once-daily fluticasone furoate (FF)/vilanterol reduces risk of severe exacerbations in asthma versus FF alone. Thorax. 2014 Apr;69(4):312-9. doi: 10.1136/thoraxjnl-2013-203600. Epub 2013 Nov 19.
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01086384