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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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
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 - 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.
Timepoint [1] 0 0
Baseline to Follow-up (up to 76 weeks of treatment)
Secondary outcome [1] 0 0
Number of Severe Asthma Exacerbations - 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.
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 - 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.
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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
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United States of America
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Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
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Idaho
Country [8] 0 0
United States of America
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Illinois
Country [9] 0 0
United States of America
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Indiana
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United States of America
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Kentucky
Country [11] 0 0
United States of America
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Louisiana
Country [12] 0 0
United States of America
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Maryland
Country [13] 0 0
United States of America
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New York
Country [14] 0 0
United States of America
State/province [14] 0 0
Ohio
Country [15] 0 0
United States of America
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Oklahoma
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United States of America
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Oregon
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United States of America
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Pennsylvania
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United States of America
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South Carolina
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United States of America
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Tennessee
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United States of America
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Texas
Country [21] 0 0
United States of America
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Vermont
Country [22] 0 0
United States of America
State/province [22] 0 0
Washington
Country [23] 0 0
United States of America
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Wisconsin
Country [24] 0 0
Argentina
State/province [24] 0 0
Buenos Aires
Country [25] 0 0
Argentina
State/province [25] 0 0
Entre Ríos
Country [26] 0 0
Argentina
State/province [26] 0 0
Santa Fe
Country [27] 0 0
Argentina
State/province [27] 0 0
Ciudad Autónoma de Buenos Aires
Country [28] 0 0
Argentina
State/province [28] 0 0
Mendoza
Country [29] 0 0
Argentina
State/province [29] 0 0
Tucuman
Country [30] 0 0
Germany
State/province [30] 0 0
Baden-Wuerttemberg
Country [31] 0 0
Germany
State/province [31] 0 0
Bayern
Country [32] 0 0
Germany
State/province [32] 0 0
Brandenburg
Country [33] 0 0
Germany
State/province [33] 0 0
Hessen
Country [34] 0 0
Germany
State/province [34] 0 0
Nordrhein-Westfalen
Country [35] 0 0
Germany
State/province [35] 0 0
Rheinland-Pfalz
Country [36] 0 0
Germany
State/province [36] 0 0
Sachsen
Country [37] 0 0
Germany
State/province [37] 0 0
Thueringen
Country [38] 0 0
Germany
State/province [38] 0 0
Berlin
Country [39] 0 0
Germany
State/province [39] 0 0
Hamburg
Country [40] 0 0
Japan
State/province [40] 0 0
Fukuoka
Country [41] 0 0
Japan
State/province [41] 0 0
Hokkaido
Country [42] 0 0
Japan
State/province [42] 0 0
Kagoshima
Country [43] 0 0
Japan
State/province [43] 0 0
Kanagawa
Country [44] 0 0
Japan
State/province [44] 0 0
Kyoto
Country [45] 0 0
Japan
State/province [45] 0 0
Saitama
Country [46] 0 0
Japan
State/province [46] 0 0
Tokyo
Country [47] 0 0
Mexico
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Jalisco
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Mexico
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Nuevo León
Country [49] 0 0
Mexico
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Tabasco
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Mexico
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Mexico city
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Mexico
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Mexico City
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Philippines
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Iloilo City
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Philippines
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Lipa City
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Philippines
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Marilao, Bulacan
Country [55] 0 0
Philippines
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Quezon City
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Poland
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Bydgoszcz
Country [57] 0 0
Poland
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Debica
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Poland
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Gdansk
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Poland
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Kielce
Country [60] 0 0
Poland
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Koszalin
Country [61] 0 0
Poland
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Krakow
Country [62] 0 0
Poland
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Lublin
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Poland
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Olsztyn
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Poland
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Poznan
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Poland
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Rzeszow
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Poland
State/province [66] 0 0
Wolomin
Country [67] 0 0
Poland
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Wroclaw
Country [68] 0 0
Romania
State/province [68] 0 0
Bucharest
Country [69] 0 0
Romania
State/province [69] 0 0
Craiova
Country [70] 0 0
Romania
State/province [70] 0 0
Deva
Country [71] 0 0
Romania
State/province [71] 0 0
Pitesti
Country [72] 0 0
Romania
State/province [72] 0 0
Sibiu
Country [73] 0 0
Russian Federation
State/province [73] 0 0
Barnaul
Country [74] 0 0
Russian Federation
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Blagoveshchensk
Country [75] 0 0
Russian Federation
State/province [75] 0 0
Chelyabinsk
Country [76] 0 0
Russian Federation
State/province [76] 0 0
Kazan
Country [77] 0 0
Russian Federation
State/province [77] 0 0
Krasnodar
Country [78] 0 0
Russian Federation
State/province [78] 0 0
Novosibirsk
Country [79] 0 0
Russian Federation
State/province [79] 0 0
Penza
Country [80] 0 0
Russian Federation
State/province [80] 0 0
Perm
Country [81] 0 0
Russian Federation
State/province [81] 0 0
Pyatigorsk
Country [82] 0 0
Russian Federation
State/province [82] 0 0
Saint-Petersburg
Country [83] 0 0
Russian Federation
State/province [83] 0 0
Saratov
Country [84] 0 0
Russian Federation
State/province [84] 0 0
St. Petersburg
Country [85] 0 0
Russian Federation
State/province [85] 0 0
Tomsk
Country [86] 0 0
Russian Federation
State/province [86] 0 0
Volgodonsk
Country [87] 0 0
Russian Federation
State/province [87] 0 0
Voronezh
Country [88] 0 0
Ukraine
State/province [88] 0 0
Dnipropetrovsk
Country [89] 0 0
Ukraine
State/province [89] 0 0
Donetsk
Country [90] 0 0
Ukraine
State/province [90] 0 0
Kyiv
Country [91] 0 0
Ukraine
State/province [91] 0 0
Simferopol
Country [92] 0 0
Ukraine
State/province [92] 0 0
Vinnytsia
Country [93] 0 0
Ukraine
State/province [93] 0 0
Yalta
Country [94] 0 0
Ukraine
State/province [94] 0 0
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/show/NCT01086384
Trial related presentations / publications
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
Other publications