Asthma Exacerbation Study

Asthma Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01086384
• Other study ID #: 106837
• Status: Completed
• Phase: Phase 3
• First received: March 11, 2010
• Last updated: January 18, 2018
• Start date: February 22, 2010
• Est. completion date: September 15, 2011

Study information

• Verified date: January 2018
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2020
• Est. completion date: September 15, 2011
• Est. primary completion date: September 1, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Fluticasone Furoate/GW642444
Combination inhaled corticosteroid and long-acting beta2-agonist
• Fluticasone furoate
Inhaled corticosteroid

Locations

Country	Name	City	State
Argentina	GSK Investigational Site	Buenos Aires
Argentina	GSK Investigational Site	Buenos Aires
Argentina	GSK Investigational Site	Ciudad Autónoma de Buenos Aires
Argentina	GSK Investigational Site	Ciudad Autónoma de Buenos Aires
Argentina	GSK Investigational Site	Mendoza
Argentina	GSK Investigational Site	Parana	Entre Ríos
Argentina	GSK Investigational Site	Quilmes	Buenos Aires
Argentina	GSK Investigational Site	Rosario	Santa Fe
Argentina	GSK Investigational Site	Tucuman
Australia	GSK Investigational Site	Auchenflower	Queensland
Australia	GSK Investigational Site	Blacktown	New South Wales
Australia	GSK Investigational Site	Clayton	Victoria
Australia	GSK Investigational Site	Garran	Australian Capital Territory
Australia	GSK Investigational Site	Hornsby	New South Wales
Australia	GSK Investigational Site	Toorak Gardens	South Australia
Germany	GSK Investigational Site	Aschaffenburg	Bayern
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Bochum	Nordrhein-Westfalen
Germany	GSK Investigational Site	Cottbus	Brandenburg
Germany	GSK Investigational Site	Deggingen	Baden-Wuerttemberg
Germany	GSK Investigational Site	Dortmund	Nordrhein-Westfalen
Germany	GSK Investigational Site	Erfurt	Thueringen
Germany	GSK Investigational Site	Essen	Nordrhein-Westfalen
Germany	GSK Investigational Site	Frankfurt	Hessen
Germany	GSK Investigational Site	Frankfurt	Hessen
Germany	GSK Investigational Site	Gelsenkirchen	Nordrhein-Westfalen
Germany	GSK Investigational Site	Goch	Nordrhein-Westfalen
Germany	GSK Investigational Site	Grossheirath	Bayern
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Koblenz	Rheinland-Pfalz
Germany	GSK Investigational Site	Leipzig	Sachsen
Germany	GSK Investigational Site	Mainz	Rheinland-Pfalz
Germany	GSK Investigational Site	Marburg	Hessen
Germany	GSK Investigational Site	Potsdam	Brandenburg
Germany	GSK Investigational Site	Rhaunen	Rheinland-Pfalz
Germany	GSK Investigational Site	Ruedersdorf	Brandenburg
Germany	GSK Investigational Site	Solingen	Nordrhein-Westfalen
Germany	GSK Investigational Site	Vilshofen	Bayern
Germany	GSK Investigational Site	Weinheim	Baden-Wuerttemberg
Germany	GSK Investigational Site	Witten	Nordrhein-Westfalen
Japan	GSK Investigational Site	Fukuoka
Japan	GSK Investigational Site	Fukuoka
Japan	GSK Investigational Site	Hokkaido
Japan	GSK Investigational Site	Kagoshima
Japan	GSK Investigational Site	Kagoshima
Japan	GSK Investigational Site	Kanagawa
Japan	GSK Investigational Site	Kyoto
Japan	GSK Investigational Site	Kyoto
Japan	GSK Investigational Site	Saitama
Japan	GSK Investigational Site	Tokyo
Japan	GSK Investigational Site	Tokyo
Japan	GSK Investigational Site	Tokyo
Japan	GSK Investigational Site	Tokyo
Japan	GSK Investigational Site	Tokyo
Mexico	GSK Investigational Site	Guadalajara	Jalisco
Mexico	GSK Investigational Site	Mexico city
Mexico	GSK Investigational Site	Mexico City
Mexico	GSK Investigational Site	Monterrey NL	Nuevo León
Mexico	GSK Investigational Site	Villahermosa	Tabasco
Mexico	GSK Investigational Site	Zapopan	Jalisco
Philippines	GSK Investigational Site	Iloilo City
Philippines	GSK Investigational Site	Lipa City
Philippines	GSK Investigational Site	Marilao, Bulacan
Philippines	GSK Investigational Site	Quezon City
Philippines	GSK Investigational Site	Quezon City
Poland	GSK Investigational Site	Bydgoszcz
Poland	GSK Investigational Site	Debica
Poland	GSK Investigational Site	Gdansk
Poland	GSK Investigational Site	Kielce
Poland	GSK Investigational Site	Koszalin
Poland	GSK Investigational Site	Krakow
Poland	GSK Investigational Site	Lublin
Poland	GSK Investigational Site	Lublin
Poland	GSK Investigational Site	Olsztyn
Poland	GSK Investigational Site	Poznan
Poland	GSK Investigational Site	Poznan
Poland	GSK Investigational Site	Rzeszow
Poland	GSK Investigational Site	Wolomin
Poland	GSK Investigational Site	Wroclaw
Poland	GSK Investigational Site	Wroclaw
Romania	GSK Investigational Site	Bucharest
Romania	GSK Investigational Site	Bucharest
Romania	GSK Investigational Site	Craiova
Romania	GSK Investigational Site	Deva
Romania	GSK Investigational Site	Pitesti
Romania	GSK Investigational Site	Sibiu
Russian Federation	GSK Investigational Site	Barnaul
Russian Federation	GSK Investigational Site	Blagoveshchensk
Russian Federation	GSK Investigational Site	Chelyabinsk
Russian Federation	GSK Investigational Site	Kazan
Russian Federation	GSK Investigational Site	Krasnodar
Russian Federation	GSK Investigational Site	Novosibirsk
Russian Federation	GSK Investigational Site	Novosibirsk
Russian Federation	GSK Investigational Site	Penza
Russian Federation	GSK Investigational Site	Perm
Russian Federation	GSK Investigational Site	Pyatigorsk
Russian Federation	GSK Investigational Site	Saint-Petersburg
Russian Federation	GSK Investigational Site	Saratov
Russian Federation	GSK Investigational Site	St. Petersburg
Russian Federation	GSK Investigational Site	Tomsk
Russian Federation	GSK Investigational Site	Volgodonsk
Russian Federation	GSK Investigational Site	Voronezh
Ukraine	GSK Investigational Site	Dnipropetrovsk
Ukraine	GSK Investigational Site	Donetsk
Ukraine	GSK Investigational Site	Kyiv
Ukraine	GSK Investigational Site	Kyiv
Ukraine	GSK Investigational Site	Kyiv
Ukraine	GSK Investigational Site	Kyiv
Ukraine	GSK Investigational Site	Kyiv
Ukraine	GSK Investigational Site	Kyiv
Ukraine	GSK Investigational Site	Kyiv
Ukraine	GSK Investigational Site	Simferopol
Ukraine	GSK Investigational Site	Vinnytsia
Ukraine	GSK Investigational Site	Yalta
Ukraine	GSK Investigational Site	Zaporizhia
Ukraine	GSK Investigational Site	Zaporizhia
United States	GSK Investigational Site	Albany	Georgia
United States	GSK Investigational Site	Austin	Texas
United States	GSK Investigational Site	Baltimore	Maryland
United States	GSK Investigational Site	Bell Gardens	California
United States	GSK Investigational Site	Bellingham	Washington
United States	GSK Investigational Site	Birmingham	Alabama
United States	GSK Investigational Site	Bronx	New York
United States	GSK Investigational Site	Canton	Ohio
United States	GSK Investigational Site	Charleston	South Carolina
United States	GSK Investigational Site	Cincinnati	Ohio
United States	GSK Investigational Site	Cocoa	Florida
United States	GSK Investigational Site	Coeur d'Alene	Idaho
United States	GSK Investigational Site	Collegeville	Pennsylvania
United States	GSK Investigational Site	Columbus	Georgia
United States	GSK Investigational Site	Denver	Colorado
United States	GSK Investigational Site	Englewood	Colorado
United States	GSK Investigational Site	Eugene	Oregon
United States	GSK Investigational Site	Fresno	California
United States	GSK Investigational Site	Gaffney	South Carolina
United States	GSK Investigational Site	Hazard	Kentucky
United States	GSK Investigational Site	Houston	Texas
United States	GSK Investigational Site	Houston	Texas
United States	GSK Investigational Site	Huntington Beach	California
United States	GSK Investigational Site	Indianapolis	Indiana
United States	GSK Investigational Site	Killeen	Texas
United States	GSK Investigational Site	Knoxville	Tennessee
United States	GSK Investigational Site	La Crosse	Wisconsin
United States	GSK Investigational Site	Lawrenceville	Georgia
United States	GSK Investigational Site	Long Beach	California
United States	GSK Investigational Site	Los Angeles	California
United States	GSK Investigational Site	Medford	Oregon
United States	GSK Investigational Site	Metairie	Louisiana
United States	GSK Investigational Site	Miami	Florida
United States	GSK Investigational Site	Mission Viejo	California
United States	GSK Investigational Site	Mobile	Alabama
United States	GSK Investigational Site	Napa	California
United States	GSK Investigational Site	Oklahoma City	Oklahoma
United States	GSK Investigational Site	Oklahoma City	Oklahoma
United States	GSK Investigational Site	Owensboro	Kentucky
United States	GSK Investigational Site	Oxford	Alabama
United States	GSK Investigational Site	Philadelphia	Pennsylvania
United States	GSK Investigational Site	Philadelphia	Pennsylvania
United States	GSK Investigational Site	Phoenix	Arizona
United States	GSK Investigational Site	Pittsburgh	Pennsylvania
United States	GSK Investigational Site	Rancho Mirage	California
United States	GSK Investigational Site	River Forest	Illinois
United States	GSK Investigational Site	Riverside	California
United States	GSK Investigational Site	Rockville Center	New York
United States	GSK Investigational Site	Rolling Hills Estates	California
United States	GSK Investigational Site	Roseville	California
United States	GSK Investigational Site	San Antonio	Texas
United States	GSK Investigational Site	San Diego	California
United States	GSK Investigational Site	Scottsdale	Arizona
United States	GSK Investigational Site	South Burlington	Vermont
United States	GSK Investigational Site	Spartanburg	South Carolina
United States	GSK Investigational Site	Stockton	California
United States	GSK Investigational Site	Sunset	Louisiana
United States	GSK Investigational Site	Sylvania	Ohio
United States	GSK Investigational Site	Torrance	California
United States	GSK Investigational Site	Tucson	Arizona
United States	GSK Investigational Site	Union	South Carolina
United States	GSK Investigational Site	Valrico	Florida
United States	GSK Investigational Site	Waco	Texas
United States	GSK Investigational Site	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Germany,  Japan,  Mexico,  Philippines,  Poland,  Romania,  Russian Federation,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Baseline to Follow-up (up to 76 weeks of treatment)
Secondary	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.	Baseline and Week 36

External Links

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