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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

248 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2012-08-31

Brief Summary

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A randomised, double-blind, placebo-controlled (with rescue medication), multi-centre study to evaluate the efficacy and safety of inhaled fluticasone furoate in the treatment of persistent asthma in adults and adolescents not currently receiving inhaled corticosteroids

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Detailed Description

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This will be a multi-centre, randomised, placebo controlled (with rescue medication), double-blind, 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 score and rescue albuterol/salbutamol use. At Visit 2 (end of run-in/Randomisation Visit), subjects meeting the eligibility criteria will be randomised to either inhaled Fluticasone Furoate 50 mcg or inhaled placebo. In addition all subjects will be supplied with albuterol/salbutamol inhalation aerosol to use as required to treat symptoms. Subjects will attend 4 on-treatment visits at Visits 3, 4, 5, and 6 (Weeks 2, 4, 8 and 12 respectively). Subjects will receive treatment for 84 days (12 weeks). A follow-up contact will be performed 1-week after completing study medication (Visit 7). Subjects will participate in the study for up to a maximum of 15 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 50mcg

Inhalation powder delivered by Novel Dry Powder Inhaler

Group Type EXPERIMENTAL

Fluticasone furoate 50mcg

Intervention Type DRUG

Inhalation powder delivered by Novel Dry Powder Inhaler

Placebo

Inhalation powder delivered by Novel Dry Powder Inhaler

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Inhalation powder delivered by Novel Dry Powder Inhaler

Interventions

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Fluticasone furoate 50mcg

Inhalation powder delivered by Novel Dry Powder Inhaler

Intervention Type DRUG

Placebo

Inhalation powder delivered by Novel Dry Powder Inhaler

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Signed informed consent
* Outpatient at least 12 years of age with diagnosis of asthma at least 12 weeks before 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 200mls
* Current asthma therapy that includes a non-corticosteroid controller and/or short-acting beta agonist

Exclusion Criteria

* History of life-threatening asthma exacerbation within the past 10 years
* Asthma exacerbation requiring treatment with oral corticosteroids within the last 3 months or that required overnight hospital stay within 6 months
* Current or recent respiratory infection or current oral candida infection
* Presence of another significant respiratory disease or medical condition that is not controlled or that could affect subject safety or study outcome
* Known or suspected allergy to study drug or materials
* Taking another investigational medication or prohibited medication during the study
* Previous treatment with inhaled fluticasone furoate in a phase II or III study
* Current smokers or former smokers with significant tobacco exposure
* Children in Care

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

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

Long Beach, California, United States

Site Status

GSK Investigational Site

Los Angeles, California, United States

Site Status

GSK Investigational Site

Newport Beach, California, United States

Site Status

GSK Investigational Site

Albany, Georgia, United States

Site Status

GSK Investigational Site

Columbia, Missouri, United States

Site Status

GSK Investigational Site

Oklahoma City, Oklahoma, United States

Site Status

GSK Investigational Site

Orangeburg, South Carolina, United States

Site Status

GSK Investigational Site

Spartanburg, South Carolina, United States

Site Status

GSK Investigational Site

Corsicana, Texas, United States

Site Status

GSK Investigational Site

Waco, Texas, United States

Site Status

GSK Investigational Site

Zapopan, Jalisco, Mexico

Site Status

GSK Investigational Site

Morelia, Michoacán, Mexico

Site Status

GSK Investigational Site

Villahermosa, Tabasco, Mexico

Site Status

GSK Investigational Site

Lima, Lima Province, Peru

Site Status

GSK Investigational Site

Lima, Lima Province, Peru

Site Status

GSK Investigational Site

Lima, Lima Province, Peru

Site Status

GSK Investigational Site

San Borja, Lima region, Peru

Site Status

GSK Investigational Site

San Miguel, Lima region, Peru

Site Status

GSK Investigational Site

Klin, , Russia

Site Status

GSK Investigational Site

Moscow, , Russia

Site Status

GSK Investigational Site

Saint Petersburg, , Russia

Site Status

GSK Investigational Site

Saratov, , Russia

Site Status

GSK Investigational Site

Voronezh, , Russia

Site Status

GSK Investigational Site

Yaroslavl, , Russia

Site Status

Countries

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United States Mexico Peru 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)

O'Byrne PM, Woodcock A, Bleecker ER, Bateman ED, Lotvall J, Forth R, Medley H, Jacques L, Busse WW. Efficacy and safety of once-daily fluticasone furoate 50 mcg in adults with persistent asthma: a 12-week randomized trial. Respir Res. 2014 Aug 11;15(1):88. doi: 10.1186/s12931-014-0088-z.

Reference Type DERIVED

PMID: 25108545 (View on PubMed)

Svedsater H, Jacques L, Goldfrad C, Bleecker ER. Ease of use of the ELLIPTA dry powder inhaler: data from three randomised controlled trials in patients with asthma. NPJ Prim Care Respir Med. 2014 Jun 26;24:14019. doi: 10.1038/npjpcrm.2014.19. No abstract available.

Reference Type DERIVED

PMID: 24966061 (View on PubMed)

Study Documents

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