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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

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
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
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Arizona
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United States of America
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California
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United States of America
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Colorado
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
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Idaho
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United States of America
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Illinois
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United States of America
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Indiana
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United States of America
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Kentucky
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United States of America
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Louisiana
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United States of America
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Maryland
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New York
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Ohio
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Oklahoma
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Oregon
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Pennsylvania
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South Carolina
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Tennessee
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Texas
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Vermont
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Washington
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United States of America
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Wisconsin
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Argentina
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Buenos Aires
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Argentina
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Entre Ríos
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Argentina
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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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Germany
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Bayern
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Germany
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Brandenburg
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Germany
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Hessen
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Germany
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Nordrhein-Westfalen
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Germany
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Rheinland-Pfalz
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Germany
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Sachsen
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Germany
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Thueringen
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Germany
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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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Japan
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Hokkaido
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Japan
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Kagoshima
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Japan
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Kanagawa
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Japan
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Kyoto
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Japan
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Saitama
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Japan
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Tokyo
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Mexico
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Jalisco
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Mexico
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Nuevo León
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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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Iloilo City
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Philippines
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Lipa City
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Philippines
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Marilao, Bulacan
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Philippines
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Quezon City
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Poland
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Bydgoszcz
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Debica
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Gdansk
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Kielce
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Krakow
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Lublin
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Rzeszow
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Wolomin
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Wroclaw
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Romania
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Bucharest
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Romania
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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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Russian Federation
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Blagoveshchensk
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Russian Federation
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Chelyabinsk
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Russian Federation
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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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Russian Federation
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Perm
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Russian Federation
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Pyatigorsk
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Russian Federation
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Saint-Petersburg
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Russian Federation
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Saratov
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Russian Federation
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St. Petersburg
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Russian Federation
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Tomsk
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Russian Federation
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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
Country [93] 0 0
Ukraine
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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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT01086384