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Asthma Exacerbation Study

NCT ID: NCT01086384

Last Updated: 2018-01-24

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

2020 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-22

Study Completion Date

2011-09-15

Brief Summary

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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.

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Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Fluticasone furoate/GW642444

Group Type EXPERIMENTAL

Fluticasone Furoate/GW642444

Intervention Type DRUG

Combination inhaled corticosteroid and long-acting beta2-agonist

fluticasone furoate

Group Type EXPERIMENTAL

Fluticasone furoate

Intervention Type DRUG

Inhaled corticosteroid

Interventions

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Fluticasone Furoate/GW642444

Combination inhaled corticosteroid and long-acting beta2-agonist

Intervention Type DRUG

Fluticasone furoate

Inhaled corticosteroid

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Birmingham, Alabama, United States

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Mobile, Alabama, United States

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Oxford, Alabama, United States

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Phoenix, Arizona, United States

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Scottsdale, Arizona, United States

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Tucson, Arizona, United States

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Bell Gardens, California, United States

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Fresno, California, United States

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Huntington Beach, California, United States

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Long Beach, California, United States

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Los Angeles, California, United States

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Mission Viejo, California, United States

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Napa, California, United States

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Rancho Mirage, California, United States

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Riverside, California, United States

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Rolling Hills Estates, California, United States

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Roseville, California, United States

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San Diego, California, United States

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Stockton, California, United States

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Torrance, California, United States

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Denver, Colorado, United States

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Englewood, Colorado, United States

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Cocoa, Florida, United States

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Miami, Florida, United States

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Valrico, Florida, United States

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Winter Park, Florida, United States

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Albany, Georgia, United States

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Columbus, Georgia, United States

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Lawrenceville, Georgia, United States

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Coeur d'Alene, Idaho, United States

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River Forest, Illinois, United States

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Indianapolis, Indiana, United States

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Hazard, Kentucky, United States

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Owensboro, Kentucky, United States

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Metairie, Louisiana, United States

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Sunset, Louisiana, United States

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Baltimore, Maryland, United States

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Rockville Centre, New York, United States

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The Bronx, New York, United States

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Canton, Ohio, United States

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Cincinnati, Ohio, United States

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Sylvania, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Oklahoma City, Oklahoma, United States

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Eugene, Oregon, United States

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Medford, Oregon, United States

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Collegeville, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Charleston, South Carolina, United States

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Gaffney, South Carolina, United States

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Spartanburg, South Carolina, United States

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Union, South Carolina, United States

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Knoxville, Tennessee, United States

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Austin, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Killeen, Texas, United States

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San Antonio, Texas, United States

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Waco, Texas, United States

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South Burlington, Vermont, United States

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Bellingham, Washington, United States

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La Crosse, Wisconsin, United States

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Quilmes, Buenos Aires, Argentina

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Paraná, Entre Ríos Province, Argentina

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Rosario, Santa Fe Province, Argentina

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Buenos Aires, , Argentina

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Buenos Aires, , Argentina

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Buenos Aires, , Argentina

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Buenos Aires, , Argentina

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Mendoza, , Argentina

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San Miguel de Tucumán, , Argentina

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Garran, Australian Capital Territory, Australia

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Blacktown, New South Wales, Australia

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Hornsby, New South Wales, Australia

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Auchenflower, Queensland, Australia

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Toorak Gardens, South Australia, Australia

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Clayton, Victoria, Australia

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Deggingen, Baden-Wurttemberg, Germany

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Weinheim, Baden-Wurttemberg, Germany

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Aschaffenburg, Bavaria, Germany

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Großheirath, Bavaria, Germany

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Vilshofen, Bavaria, Germany

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Cottbus, Brandenburg, Germany

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Potsdam, Brandenburg, Germany

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Rüdersdorf, Brandenburg, Germany

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Frankfurt am Main, Hesse, Germany

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Frankfurt am Main, Hesse, Germany

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Marburg, Hesse, Germany

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Bochum, North Rhine-Westphalia, Germany

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Dortmund, North Rhine-Westphalia, Germany

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Essen, North Rhine-Westphalia, Germany

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Gelsenkirchen, North Rhine-Westphalia, Germany

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Goch, North Rhine-Westphalia, Germany

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Solingen, North Rhine-Westphalia, Germany

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Witten, North Rhine-Westphalia, Germany

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Koblenz, Rhineland-Palatinate, Germany

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Mainz, Rhineland-Palatinate, Germany

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Rhaunen, Rhineland-Palatinate, Germany

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Leipzig, Saxony, Germany

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Erfurt, Thuringia, Germany

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Berlin, , Germany

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Hamburg, , Germany

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Hamburg, , Germany

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Hamburg, , Germany

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Hamburg, , Germany

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Fukuoka, , Japan

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Fukuoka, , Japan

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Hokkaido, , Japan

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Kagoshima, , Japan

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Kagoshima, , Japan

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Kanagawa, , Japan

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Kyoto, , Japan

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Kyoto, , Japan

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Saitama, , Japan

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Tokyo, , Japan

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Tokyo, , Japan

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Tokyo, , Japan

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Tokyo, , Japan

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Tokyo, , Japan

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Guadalajara, Jalisco, Mexico

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Zapopan, Jalisco, Mexico

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Monterrey NL, Nuevo León, Mexico

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Villahermosa, Tabasco, Mexico

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Mexico City, , Mexico

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Mexico City, , Mexico

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Iloilo City, , Philippines

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Lipa City, , Philippines

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Marilao, Bulacan, , Philippines

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Quezon City, , Philippines

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Quezon City, , Philippines

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Bydgoszcz, , Poland

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Dębica, , Poland

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Gdansk, , Poland

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Kielce, , Poland

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Koszalin, , Poland

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Krakow, , Poland

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Lublin, , Poland

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Lublin, , Poland

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Olsztyn, , Poland

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Poznan, , Poland

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Poznan, , Poland

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Rzeszów, , Poland

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Wołomin, , Poland

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Wroclaw, , Poland

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Wroclaw, , Poland

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Bucharest, , Romania

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Bucharest, , Romania

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Craiova, , Romania

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Deva, , Romania

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Piteşti, , Romania

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Sibiu, , Romania

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Barnaul, , Russia

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Blagoveshchensk, , Russia

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Chelyabinsk, , Russia

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Kazan', , Russia

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Krasnodar, , Russia

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Novosibirsk, , Russia

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Novosibirsk, , Russia

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Penza, , Russia

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Perm, , Russia

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Pyatigorsk, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saratov, , Russia

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Tomsk, , Russia

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Volgodonsk, , Russia

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Voronezh, , Russia

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Dnipropetrovsk, , Ukraine

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Donetsk, , Ukraine

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Kyiv, , Ukraine

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Kyiv, , Ukraine

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Kyiv, , Ukraine

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Kyiv, , Ukraine

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Kyiv, , Ukraine

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Kyiv, , Ukraine

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Kyiv, , Ukraine

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Simferopol, , Ukraine

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Vinnytsia, , Ukraine

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Yalta, , Ukraine

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Zaporizhia, , Ukraine

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Zaporizhia, , Ukraine

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Countries

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United States Argentina Australia Germany Japan Mexico Philippines Poland Romania Russia Ukraine

References

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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.

Reference Type DERIVED
PMID: 27881132 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26704701 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24253831 (View on PubMed)

Study Documents

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Document Type: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

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https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

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106837

Identifier Type: -

Identifier Source: org_study_id

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