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Evaluating the Efficacy and Safety of Fluticasone Furoate Inhalation Powder in the Treatment of Asthma in Adults and Adolescents

NCT ID: NCT01159912

Last Updated: 2017-11-09

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2012-01-16

Brief Summary

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A randomised, double-blind, double-dummy, placebo controlled (with rescue medication), multicenter study to evaluate the efficacy and safety of Fluticasone Furoate inhalation powder in the treatment of persistent asthma in adults and adolescents.

Detailed Description

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This is a multi-center, randomized, double-blind, double-dummy, parallel-group study to compare the efficacy and safety of Fluticasone Furoate Inhalation Powder 100mcg once daily and Fluticasone Propionate Inhalation Powder 250mcg twice daily with Placebo. Subjects will participate in the study for up to a maximum of 29 weeks (including screening, treatment and follow-up contact). The primary endpoint consists of change from baseline in clinic visit trough (pre-bronchodilator and pre-dose) FEV1 at the end of the 24 week treatment period. The nominated powered secondary endpoint is the change from baseline in the percentage of rescue-free 24 hour periods during the 24-week treatment period. Safety assessments include adverse events, oropharyngeal examinations, clinical chemistry and urine cortisol excretion. For subjects who have consented for pharmacogenetics, a blood sample will also be taken for pharmacogenetic analysis.

Conditions

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Asthma

Keywords

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fluticasone propionate Fluticasone furoate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Fluticasone Furoate OD and Placebo BID

Fluticasone furoate inhalation powder once daily and placebo inhalation powder twice daily for 24 weeks

Group Type EXPERIMENTAL

Fluticasone furoate

Intervention Type DRUG

Fluticasone furoate inhalation powder, 100 µg

Placebo

Intervention Type DRUG

Placebo inhalation powder

Fluticasone Propionate BID and Placebo OD

Fluticasone propionate inhalation powder twice daily and placebo inhalation powder once daily for 24 weeks

Group Type ACTIVE_COMPARATOR

Fluticasone propionate

Intervention Type DRUG

Fluticasone propionate inhalation powder, 250 µg

Placebo

Intervention Type DRUG

Placebo inhalation powder

Placebo only BID

Placebo inhalation powder twice daily for 24 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo inhalation powder

Interventions

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Fluticasone propionate

Fluticasone propionate inhalation powder, 250 µg

Intervention Type DRUG

Fluticasone furoate

Fluticasone furoate inhalation powder, 100 µg

Intervention Type DRUG

Placebo

Placebo inhalation powder

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Signed informed consent
* Outpatient at least 12 years of age
* Both genders; females of child bearing potential must be willing to use approved birth control method
* Pre-bronchodilator FEV1 of 40-90% predicted
* Reversibility FEV1 of at least 12% and 200mLs
* Current asthma therapy that includes an inhaled corticosteroid for at least 4 weeks prior to first visit

Exclusion Criteria

* History of life threatening asthma
* Respiratory infection or candidiasis
* Asthma exacerbation within 6 months prior to first visit
* Concurrent respiratory disease or other disease that would confound study participation or affect subject safety
* Allergies to study drugs, study drug excipients, medications related to study drugs
* Taking another investigational medication or medication prohibited for use during this study
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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Montgomery, Alabama, United States

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Green Valley, Arizona, United States

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Little Rock, Arkansas, United States

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Bakersfield, California, United States

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Encinitas, 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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Long Beach, California, United States

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Newport Beach, California, United States

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Orange, 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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San Diego, California, United States

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San Diego, California, United States

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San Diego, California, United States

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San Diego, California, United States

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San Jose, California, United States

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Cutler Bay, Florida, United States

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Edgewater, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Orlando, Florida, United States

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Albany, Georgia, United States

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Columbus, Georgia, United States

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Shiloh, Illinois, United States

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Lenexa, Kansas, 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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Columbia, Missouri, United States

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St Louis, Missouri, United States

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Bellevue, Nebraska, United States

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Las Vegas, Nevada, United States

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Shelby, North Carolina, United States

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Canton, Ohio, United States

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Dayton, Ohio, United States

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Franklin, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Medford, Oregon, United States

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Collegeville, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Greenville, South Carolina, United States

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Orangeburg, South Carolina, United States

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Austin, Texas, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Kerrville, Texas, United States

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San Antonio, Texas, United States

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San Antonio, Texas, United States

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San Antonio, Texas, United States

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Waco, Texas, United States

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Richmond, Virginia, United States

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Gozée, , Belgium

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Halen, , Belgium

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Natoye, , Belgium

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Tremelo, , Belgium

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Rüdersdorf, Brandenburg, Germany

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Schwedt, Brandenburg, Germany

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Eschwege, Hesse, Germany

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Hanover, Lower Saxony, Germany

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Essen, North Rhine-Westphalia, Germany

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Magdeburg, Saxony-Anhalt, Germany

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Erfurt, Thuringia, Germany

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Schmölln, Thuringia, Germany

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Berlin, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Dębica, , Poland

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Kielce, , Poland

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Lodz, , Poland

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Sopot, , Poland

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Szczecin, , Poland

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Łomża, , Poland

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Bucharest, , Romania

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Bucharest, , Romania

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Bucharest, , Romania

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Bucharest, , Romania

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Bucharest, , Romania

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Iași, , Romania

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Countries

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United States Belgium Germany Poland Romania

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)

Study Documents

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Document Type: Dataset Specification

View Document

Document Type: Clinical Study Report

View Document

Document Type: Individual Participant Data Set

View Document

Document Type: Annotated Case Report Form

View Document

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Related Links

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https://www.clinicalstudydatarequest.com

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Other Identifiers

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112059

Identifier Type: -

Identifier Source: org_study_id