Asthma Exacerbation Study
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
1 other identifier
interventional
2,020
11 countries
183
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 asthma
Started Feb 2010
183 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 22, 2010
CompletedFirst Submitted
Initial submission to the registry
March 11, 2010
CompletedFirst Posted
Study publicly available on registry
March 15, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 15, 2011
CompletedResults Posted
Study results publicly available
September 11, 2013
CompletedJanuary 24, 2018
January 1, 2018
1.5 years
March 11, 2010
May 30, 2013
January 18, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Baseline to Follow-up (up to 76 weeks of treatment)
Secondary Outcomes (2)
Number of Severe Asthma Exacerbations
Baseline to Follow-up (up to 76 weeks of treatment)
Change From Baseline in Evening Pre-dose Trough FEV1 at Week 36
Baseline and Week 36
Study Arms (2)
Fluticasone furoate/GW642444
EXPERIMENTALfluticasone furoate
EXPERIMENTALInterventions
Combination inhaled corticosteroid and long-acting beta2-agonist
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (183)
GSK Investigational Site
Birmingham, Alabama, 35209, United States
GSK Investigational Site
Mobile, Alabama, 36608, United States
GSK Investigational Site
Oxford, Alabama, 36203, United States
GSK Investigational Site
Phoenix, Arizona, 85016, United States
GSK Investigational Site
Scottsdale, Arizona, 85251, United States
GSK Investigational Site
Tucson, Arizona, 85724-5073, United States
GSK Investigational Site
Bell Gardens, California, 90201, United States
GSK Investigational Site
Fresno, California, 93721, United States
GSK Investigational Site
Huntington Beach, California, 92647, United States
GSK Investigational Site
Long Beach, California, 90808, United States
GSK Investigational Site
Los Angeles, California, 90048, United States
GSK Investigational Site
Mission Viejo, California, 92691, United States
GSK Investigational Site
Napa, California, 94558, United States
GSK Investigational Site
Rancho Mirage, California, 92270, United States
GSK Investigational Site
Riverside, California, 92506, United States
GSK Investigational Site
Rolling Hills Estates, California, 90274, United States
GSK Investigational Site
Roseville, California, 95661, United States
GSK Investigational Site
San Diego, California, 92120, United States
GSK Investigational Site
Stockton, California, 95207, United States
GSK Investigational Site
Torrance, California, 90505, United States
GSK Investigational Site
Denver, Colorado, 80230, United States
GSK Investigational Site
Englewood, Colorado, 80112, United States
GSK Investigational Site
Cocoa, Florida, 32927, United States
GSK Investigational Site
Miami, Florida, 33173, United States
GSK Investigational Site
Valrico, Florida, 33596, United States
GSK Investigational Site
Winter Park, Florida, 32789, United States
GSK Investigational Site
Albany, Georgia, 31707, United States
GSK Investigational Site
Columbus, Georgia, 31904, United States
GSK Investigational Site
Lawrenceville, Georgia, 30046, United States
GSK Investigational Site
Coeur d'Alene, Idaho, 83814, United States
GSK Investigational Site
River Forest, Illinois, 60305, United States
GSK Investigational Site
Indianapolis, Indiana, 46256, United States
GSK Investigational Site
Hazard, Kentucky, 41701, United States
GSK Investigational Site
Owensboro, Kentucky, 42301, United States
GSK Investigational Site
Metairie, Louisiana, 70006, United States
GSK Investigational Site
Sunset, Louisiana, 70584, United States
GSK Investigational Site
Baltimore, Maryland, 21236, United States
GSK Investigational Site
Rockville Centre, New York, 11570, United States
GSK Investigational Site
The Bronx, New York, 10461, United States
GSK Investigational Site
Canton, Ohio, 44718, United States
GSK Investigational Site
Cincinnati, Ohio, 45231, United States
GSK Investigational Site
Sylvania, Ohio, 43560, United States
GSK Investigational Site
Oklahoma City, Oklahoma, 73103, United States
GSK Investigational Site
Oklahoma City, Oklahoma, 73120, United States
GSK Investigational Site
Eugene, Oregon, 97401, United States
GSK Investigational Site
Medford, Oregon, 97504, United States
GSK Investigational Site
Collegeville, Pennsylvania, 19426, United States
GSK Investigational Site
Philadelphia, Pennsylvania, 19107, United States
GSK Investigational Site
Philadelphia, Pennsylvania, 19115, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, 15241, United States
GSK Investigational Site
Charleston, South Carolina, 29407, United States
GSK Investigational Site
Gaffney, South Carolina, 29340, United States
GSK Investigational Site
Spartanburg, South Carolina, 29303, United States
GSK Investigational Site
Union, South Carolina, 29379, United States
GSK Investigational Site
Knoxville, Tennessee, 37909, United States
GSK Investigational Site
Austin, Texas, 78750, United States
GSK Investigational Site
Houston, Texas, 77054, United States
GSK Investigational Site
Houston, Texas, 77074, United States
GSK Investigational Site
Killeen, Texas, 76542, United States
GSK Investigational Site
San Antonio, Texas, 78229, United States
GSK Investigational Site
Waco, Texas, 76712, United States
GSK Investigational Site
South Burlington, Vermont, 05403, United States
GSK Investigational Site
Bellingham, Washington, 98225, United States
GSK Investigational Site
La Crosse, Wisconsin, 54601, United States
GSK Investigational Site
Quilmes, Buenos Aires, B1878FNR, Argentina
GSK Investigational Site
Paraná, Entre Ríos Province, E3100BHK, Argentina
GSK Investigational Site
Rosario, Santa Fe Province, S2000DSR, Argentina
GSK Investigational Site
Buenos Aires, C1121ABE, Argentina
GSK Investigational Site
Buenos Aires, C1424BSF, Argentina
GSK Investigational Site
Buenos Aires, C1425BEN, Argentina
GSK Investigational Site
Buenos Aires, C1426ABP, Argentina
GSK Investigational Site
Mendoza, M5500CCG, Argentina
GSK Investigational Site
San Miguel de Tucumán, 4000, Argentina
GSK Investigational Site
Garran, Australian Capital Territory, 2606, Australia
GSK Investigational Site
Blacktown, New South Wales, 2148, Australia
GSK Investigational Site
Hornsby, New South Wales, 2077, Australia
GSK Investigational Site
Auchenflower, Queensland, 4066, Australia
GSK Investigational Site
Toorak Gardens, South Australia, 5065, Australia
GSK Investigational Site
Clayton, Victoria, 3168, Australia
GSK Investigational Site
Deggingen, Baden-Wurttemberg, 73326, Germany
GSK Investigational Site
Weinheim, Baden-Wurttemberg, 69469, Germany
GSK Investigational Site
Aschaffenburg, Bavaria, 63739, Germany
GSK Investigational Site
Großheirath, Bavaria, 96269, Germany
GSK Investigational Site
Vilshofen, Bavaria, 94474, Germany
GSK Investigational Site
Cottbus, Brandenburg, 03050, Germany
GSK Investigational Site
Potsdam, Brandenburg, 14469, Germany
GSK Investigational Site
Rüdersdorf, Brandenburg, 15562, Germany
GSK Investigational Site
Frankfurt am Main, Hesse, 60389, Germany
GSK Investigational Site
Frankfurt am Main, Hesse, 60596, Germany
GSK Investigational Site
Marburg, Hesse, 35037, Germany
GSK Investigational Site
Bochum, North Rhine-Westphalia, 44787, Germany
GSK Investigational Site
Dortmund, North Rhine-Westphalia, 44263, Germany
GSK Investigational Site
Essen, North Rhine-Westphalia, 45359, Germany
GSK Investigational Site
Gelsenkirchen, North Rhine-Westphalia, 45879, Germany
GSK Investigational Site
Goch, North Rhine-Westphalia, 47574, Germany
GSK Investigational Site
Solingen, North Rhine-Westphalia, 42651, Germany
GSK Investigational Site
Witten, North Rhine-Westphalia, 58452, Germany
GSK Investigational Site
Koblenz, Rhineland-Palatinate, 56068, Germany
GSK Investigational Site
Mainz, Rhineland-Palatinate, 55131, Germany
GSK Investigational Site
Rhaunen, Rhineland-Palatinate, 55624, Germany
GSK Investigational Site
Leipzig, Saxony, 04275, Germany
GSK Investigational Site
Erfurt, Thuringia, 99084, Germany
GSK Investigational Site
Berlin, 13086, Germany
GSK Investigational Site
Hamburg, 20357, Germany
GSK Investigational Site
Hamburg, 22299, Germany
GSK Investigational Site
Hamburg, 22335, Germany
GSK Investigational Site
Hamburg, 22767, Germany
GSK Investigational Site
Fukuoka, 802-0052, Japan
GSK Investigational Site
Fukuoka, 832-0059, Japan
GSK Investigational Site
Hokkaido, 064-0801, Japan
GSK Investigational Site
Kagoshima, 890-0064, Japan
GSK Investigational Site
Kagoshima, 892-0844, Japan
GSK Investigational Site
Kanagawa, 252-0143, Japan
GSK Investigational Site
Kyoto, 601-8206, Japan
GSK Investigational Site
Kyoto, 612-0026, Japan
GSK Investigational Site
Saitama, 343-0808, Japan
GSK Investigational Site
Tokyo, 113-0031, Japan
GSK Investigational Site
Tokyo, 153-0051, Japan
GSK Investigational Site
Tokyo, 187-0024, Japan
GSK Investigational Site
Tokyo, 190-0013, Japan
GSK Investigational Site
Tokyo, 204-0021, Japan
GSK Investigational Site
Guadalajara, Jalisco, 44100, Mexico
GSK Investigational Site
Zapopan, Jalisco, 45040, Mexico
GSK Investigational Site
Monterrey NL, Nuevo León, 64718, Mexico
GSK Investigational Site
Villahermosa, Tabasco, 86100, Mexico
GSK Investigational Site
Mexico City, 04530, Mexico
GSK Investigational Site
Mexico City, 07760, Mexico
GSK Investigational Site
Iloilo City, 5000, Philippines
GSK Investigational Site
Lipa City, 4217, Philippines
GSK Investigational Site
Marilao, Bulacan, 3019, Philippines
GSK Investigational Site
Quezon City, 1101, Philippines
GSK Investigational Site
Quezon City, 1109, Philippines
GSK Investigational Site
Bydgoszcz, 85-681, Poland
GSK Investigational Site
Dębica, 39-200, Poland
GSK Investigational Site
Gdansk, 80-169, Poland
GSK Investigational Site
Kielce, Poland
GSK Investigational Site
Koszalin, Poland
GSK Investigational Site
Krakow, 31-159, Poland
GSK Investigational Site
Lublin, 20-089, Poland
GSK Investigational Site
Lublin, 20-954, Poland
GSK Investigational Site
Olsztyn, 10-357, Poland
GSK Investigational Site
Poznan, 60-214, Poland
GSK Investigational Site
Poznan, 60-693, Poland
GSK Investigational Site
Rzeszów, Poland
GSK Investigational Site
Wołomin, 05-200, Poland
GSK Investigational Site
Wroclaw, 50-445, Poland
GSK Investigational Site
Wroclaw, 54-239, Poland
GSK Investigational Site
Bucharest, 020674, Romania
GSK Investigational Site
Bucharest, 050159, Romania
GSK Investigational Site
Craiova, 200341, Romania
GSK Investigational Site
Deva, 330084, Romania
GSK Investigational Site
Piteşti, 110084, Romania
GSK Investigational Site
Sibiu, 550166, Romania
GSK Investigational Site
Barnaul, 656 045, Russia
GSK Investigational Site
Blagoveshchensk, 675000, Russia
GSK Investigational Site
Chelyabinsk, 454106, Russia
GSK Investigational Site
Kazan', 420015, Russia
GSK Investigational Site
Krasnodar, Russia
GSK Investigational Site
Novosibirsk, 630047, Russia
GSK Investigational Site
Novosibirsk, 630087, Russia
GSK Investigational Site
Penza, 440067, Russia
GSK Investigational Site
Perm, 614077, Russia
GSK Investigational Site
Pyatigorsk, 357538, Russia
GSK Investigational Site
Saint Petersburg, 194354, Russia
GSK Investigational Site
Saint Petersburg, 197022, Russia
GSK Investigational Site
Saratov, 410028, Russia
GSK Investigational Site
Tomsk, 634001, Russia
GSK Investigational Site
Volgodonsk, 347381, Russia
GSK Investigational Site
Voronezh, 394018, Russia
GSK Investigational Site
Dnipropetrovsk, 49051, Ukraine
GSK Investigational Site
Donetsk, 83017, Ukraine
GSK Investigational Site
Kyiv, 02091, Ukraine
GSK Investigational Site
Kyiv, 02660, Ukraine
GSK Investigational Site
Kyiv, 03038, Ukraine
GSK Investigational Site
Kyiv, 03115, Ukraine
GSK Investigational Site
Kyiv, 03680, Ukraine
GSK Investigational Site
Kyiv, 04050, Ukraine
GSK Investigational Site
Kyiv, 04201, Ukraine
GSK Investigational Site
Simferopol, 95034, Ukraine
GSK Investigational Site
Vinnytsia, 21029, Ukraine
GSK Investigational Site
Yalta, 98603, Ukraine
GSK Investigational Site
Zaporizhia, 69063, Ukraine
GSK Investigational Site
Zaporizhia, 69076, Ukraine
Related Publications (3)
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.
PMID: 27881132DERIVEDGross 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.
PMID: 26704701DERIVEDBateman 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.
PMID: 24253831DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 11, 2010
First Posted
March 15, 2010
Study Start
February 22, 2010
Primary Completion
September 1, 2011
Study Completion
September 15, 2011
Last Updated
January 24, 2018
Results First Posted
September 11, 2013
Record last verified: 2018-01
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.