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Clinical Study Evaluating Safety and Efficacy of Fluticasone Furoate and Fluticasone Propionate in People With Asthma

NCT ID: NCT01436110

Last Updated: 2017-01-09

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

351 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2012-09-30

Brief Summary

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A randomised, double-blind, double-dummy, placebo controlled multi-centre study to evaluate the efficacy and safety of fluticasone furoate inhalation powder and fluticasone propionate inhalation powder in the treatment of asthma in adults and adolescents not currently treated with inhaled corticosteroids

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Detailed Description

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This will be a multi-centre, randomised, placebo and active controlled (with rescue medication), double-blind, double-dummy, parallel-group study. Subjects meeting all the inclusion criteria and none of the exclusion criteria during Visit 1 (Screening Visit) will enter a two week Run-in Period. Subjects failing screening will not be eligible for re-screening. During the run-in and double-blind treatment periods subjects will maintain an electronic daily diary to record morning and evening peak expiratory flow (PEF), asthma symptom scores and rescue albuterol/salbutamol use. At Visit 2 (end of run-in/Randomisation Visit), subjects meeting the eligibility criteria will be randomised receive treatment with either fluticasone furoate 50 mcg once daily, fluticasone propionate 100 mcg twice daily or placebo. In addition all subjects will be supplied with albuterol/salbutamol inhalation aerosol to use as required to treat symptoms. Subjects will attend 6 on-treatment visits at Visits 3, 4, 5, 6, 7 and 8 (Weeks 2, 4, 8, 12, 18 and 24 respectively). Subjects will receive treatment for 24 weeks. A follow-up contact will be performed 1-week after completing study medication (Visit 9). Subjects will participate in the study for up to a maximum of 27 weeks (including screening, treatment and follow-up contact).

Conditions

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Asthma

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 50 mcg

Once daily inhalation powder via Novel Dry Powder Inhaler

Group Type EXPERIMENTAL

Fluticasone furoate 50mcg

Intervention Type DRUG

Once daily inhalation powder via Novel Dry Powder Inhaler

Fluticasone propionate 100mcg

Twice daily inhalation powder via DISKUS/ ACCUHALER

Group Type ACTIVE_COMPARATOR

Fluticasone propionate 100mcg

Intervention Type DRUG

Twice daily inhalation powder via DISKUS/ACCUHALER

Placebo

Inhalation Powder via Novel Dry Powder Inhaler and DISKUS/ ACCUHALER

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Inhalation powder via Novel Dry Powder Inhaler and DISKUS?ACCUHALER

Interventions

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Fluticasone furoate 50mcg

Once daily inhalation powder via Novel Dry Powder Inhaler

Intervention Type DRUG

Fluticasone propionate 100mcg

Twice daily inhalation powder via DISKUS/ACCUHALER

Intervention Type DRUG

Placebo

Inhalation powder via Novel Dry Powder Inhaler and DISKUS?ACCUHALER

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Signed informed consent
* Outpatient at least 12 years of age with a diagnosis of asthma at least 12 weeks prior to first visit
* Both genders; females of child bearing potential must be willing to use appropriate contraception during the study
* Pre-bronchodilator FEV1 of at least 60% predicted
* FEV1 reversibility of at least 12% and 200ml
* Current asthma therapy that includes a non-corticosteroid controller and/or short acting beta-agonist

Exclusion Criteria

* History of life-threatening asthma exacerbation with the past 10 years
* Asthma exacerbation requiring oral corticosteroids within the past 3 months or overnight hospital stay within the past 6 months
* Current or recent respiratory infection or current oral candida infection
* Presence of a significant respiratory disease or other medical condition that is uncontrolled or that could affect subject safety or study outcome
* Known or suspected allergy to study medication or materials
* Taking another investigational medication or prohibited medication during the study
* Current smokers or former smokers with significant tobacco exposure
* Previous treatment with fluticasone furoate in a phase II or III study
* Children in Care
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

Los Angeles, California, United States

Site Status

GSK Investigational Site

Rolling Hills Estates, California, United States

Site Status

GSK Investigational Site

Sacramento, California, United States

Site Status

GSK Investigational Site

San Jose, California, United States

Site Status

GSK Investigational Site

Aventura, Florida, United States

Site Status

GSK Investigational Site

Clearwater, Florida, United States

Site Status

GSK Investigational Site

Hialeah, Florida, United States

Site Status

GSK Investigational Site

Orlando, Florida, United States

Site Status

GSK Investigational Site

Metairie, Louisiana, United States

Site Status

GSK Investigational Site

Sunset, Louisiana, United States

Site Status

GSK Investigational Site

Bethesda, Maryland, United States

Site Status

GSK Investigational Site

Columbia, Missouri, United States

Site Status

GSK Investigational Site

Las Vegas, Nevada, United States

Site Status

GSK Investigational Site

Brick, New Jersey, United States

Site Status

GSK Investigational Site

Utica, New York, United States

Site Status

GSK Investigational Site

Cincinnati, Ohio, United States

Site Status

GSK Investigational Site

Orangeburg, South Carolina, United States

Site Status

GSK Investigational Site

Corsicana, Texas, United States

Site Status

GSK Investigational Site

El Paso, Texas, United States

Site Status

GSK Investigational Site

Waco, Texas, United States

Site Status

GSK Investigational Site

Guadalajara, Jalisco, Mexico

Site Status

GSK Investigational Site

Zapopan, Jalisco, Mexico

Site Status

GSK Investigational Site

Mexico City, , Mexico

Site Status

GSK Investigational Site

Almelo, , Netherlands

Site Status

GSK Investigational Site

Eindhoven, , Netherlands

Site Status

GSK Investigational Site

Eindhoven, , Netherlands

Site Status

GSK Investigational Site

Hoogwoud, , Netherlands

Site Status

GSK Investigational Site

Zutphen, , Netherlands

Site Status

GSK Investigational Site

Lima, Lima Province, Peru

Site Status

GSK Investigational Site

Lima, Lima Province, Peru

Site Status

GSK Investigational Site

San Miguel, Lima region, Peru

Site Status

GSK Investigational Site

Lima, , Peru

Site Status

GSK Investigational Site

Bydgoszcz, , Poland

Site Status

GSK Investigational Site

Krakow, , Poland

Site Status

GSK Investigational Site

Lodz, , Poland

Site Status

GSK Investigational Site

Lublin, , Poland

Site Status

GSK Investigational Site

Poznan, , Poland

Site Status

GSK Investigational Site

Wroclaw, , Poland

Site Status

GSK Investigational Site

Kemerovo, , Russia

Site Status

GSK Investigational Site

Moscow, , Russia

Site Status

GSK Investigational Site

Novosibirsk, , Russia

Site Status

GSK Investigational Site

Saint Petersburg, , Russia

Site Status

Countries

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United States Mexico Netherlands Peru Poland Russia

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: Study Protocol

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

View Document

Document Type: Annotated Case Report Form

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: Statistical Analysis Plan

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: Clinical Study Report

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

Related Links

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https://www.clinicalstudydatarequest.com

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Other Identifiers

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115285

Identifier Type: -

Identifier Source: org_study_id

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