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

NCT ID: NCT01431950

Last Updated: 2017-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 238 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2012-10-31

Brief Summary

A randomised, double-blind, multi-centre study to evaluate the efficacy and safety of two doses of inhaled fluticasone furoate in the treatment of persistent asthma in adults and adolescents currently receiving mid to high strength inhaled corticosteroids.

Detailed Description

This will be a multi-centre, randomised, 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 four week Run-In period during which they will remain on their baseline ICS medication. In addition, all subjects will be provided with albuterol/salbutamol for relief of asthma symptoms. 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. Subjects will receive a contact (Phone Contact 1/optional office visit (1b)) during Run-In to reinforce compliance with Run-In medication and diary monitoring. Those subjects who meet the eligibility criteria at the end of the Run-In period will be stratified in an approximately 1:1 ratio according to their baseline FEV1 as a percentage of predicted normal - one stratum for those with FEV1 percent predicted ≥40% to ≤65% and one for those with FEV1 percent predicted >65% to ≤90%. Once stratified, subjects will be randomised to one of the following treatments and enter into a 24 week double-blind treatment period:1) Fluticasone furoate 100mcg once daily in the evening or 2) Fluticasone furoate 200mcg once daily in the evening.

Subjects will then attend 6 on-treatment visits at Visits 3, 4, 5, 6, 7 and 8 (Weeks 2, 4, 8, 12, 18 and 24 respectively). All visits including Visit 1 must be conducted in the evening between 5 PM and 11 PM. Subjects will receive treatment for 24 weeks. Twenty four hour urinary cortisol assessments will be collected at the end of Run-In (Visit 2) and at end of treatment (Visit 8) visits. 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 29 weeks (including screening, treatment and follow-up contact). In addition, partially used NDPIs will be collected in a subset of subjects. For subjects who have consented for pharmacogenetics, a blood sample will also be taken for pharmacogenetic analysis.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

FF 100mcg once daily

Inhaled corticosteroid (ICS)

Group Type: EXPERIMENTAL

fluticasone furoate

Intervention Type: DRUG

Inhaled corticosteroid

albuterol/salbutamol

Intervention Type: DRUG

Provided as rescue relief of asthma symptoms

FF 200mcg once daily

Inhaled corticosteroid

Group Type: EXPERIMENTAL

fluticasone furoate

Intervention Type: DRUG

Inhaled corticosteroid

albuterol/salbutamol

Intervention Type: DRUG

Provided as rescue relief of asthma symptoms

Interventions

fluticasone furoate

Inhaled corticosteroid

Intervention Type: DRUG

albuterol/salbutamol

Provided as rescue relief of asthma symptoms

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Signed informed consent
• Outpatient at least 12 years of age with 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
• Pre-bronchodilator FEV1 of 40-90% predicted
• Reversibility FEV1 of at least 12% and 200mLs
• Current asthma therapy that includes inhaled corticosteroid for at least 4 weeks prior to first visit

Exclusion Criteria

• History of life threatening asthma
• Respiratory infection or candidiasis
• Asthma exacerbation requiring OCS within last 4 weeks or overnight hospital stay within the last 3 months
• Concurrent respiratory disease or other disease that would confound study participation of 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 the study
• Previous treatment with FF or FF/VI in a phase II or III study
• Night shift workers
• Children in care

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Long Beach, California, United States

GSK Investigational Site

Newport Beach, California, United States

GSK Investigational Site

Colorado Springs, Colorado, United States

GSK Investigational Site

Clearwater, Florida, United States

GSK Investigational Site

Albany, Georgia, United States

GSK Investigational Site

Lexington, Kentucky, United States

GSK Investigational Site

Metairie, Louisiana, United States

GSK Investigational Site

Sunset, Louisiana, United States

GSK Investigational Site

Bethesda, Maryland, United States

GSK Investigational Site

Plymouth, Minnesota, United States

GSK Investigational Site

Las Vegas, Nevada, United States

GSK Investigational Site

Brick, New Jersey, United States

GSK Investigational Site

Utica, New York, United States

GSK Investigational Site

Canton, Ohio, United States

GSK Investigational Site

Cincinnati, Ohio, United States

GSK Investigational Site

Toledo, Ohio, United States

GSK Investigational Site

Oklahoma City, Oklahoma, United States

GSK Investigational Site

Orangeburg, South Carolina, United States

GSK Investigational Site

Corsicana, Texas, United States

GSK Investigational Site

Mendoza, Mendoza Province, Argentina

GSK Investigational Site

Buenos Aires, , Argentina

GSK Investigational Site

Buenos Aires, , Argentina

GSK Investigational Site

Buenos Aires, , Argentina

GSK Investigational Site

San Miguel de Tucumán, , Argentina

GSK Investigational Site

Valparaíso, Región de Valparaíso, Chile

GSK Investigational Site

Puente Alto - Santiago, Región Metro de Santiago, Chile

GSK Investigational Site

Santiago, Región Metro de Santiago, Chile

GSK Investigational Site

Aigrefeuille-sur-Maine, , France

GSK Investigational Site

Bourg-des-Comptes, , France

GSK Investigational Site

Châlons-en-Champagne, , France

GSK Investigational Site

Laon, , France

GSK Investigational Site

Nantes, , France

GSK Investigational Site

Vannes, , France

GSK Investigational Site

Villahermosa, Tabasco, Mexico

GSK Investigational Site

Mexico City, , Mexico

GSK Investigational Site

Belgorod, , Russia

GSK Investigational Site

Kazan', , Russia

GSK Investigational Site

Novokuznetsk, , Russia

GSK Investigational Site

Penza, , Russia

GSK Investigational Site

Pyatigorsk, , Russia

Countries

United States; Argentina; Chile; France; Mexico; Russia

References

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)

Woodcock A, Lotvall J, Busse WW, Bateman ED, Stone S, Ellsworth A, Jacques L. Efficacy and safety of fluticasone furoate 100 mug and 200 mug once daily in the treatment of moderate-severe asthma in adults and adolescents: a 24-week randomised study. BMC Pulm Med. 2014 Jul 9;14:113. doi: 10.1186/1471-2466-14-113.

Reference Type: DERIVED

PMID: 25007865 (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)

Svedsater H, Dale P, Garrill K, Walker R, Woepse MW. Qualitative assessment of attributes and ease of use of the ELLIPTA dry powder inhaler for delivery of maintenance therapy for asthma and COPD. BMC Pulm Med. 2013 Dec 7;13:72. doi: 10.1186/1471-2466-13-72.

Reference Type: DERIVED

PMID: 24314123 (View on PubMed)

Study Documents

Document Type: Annotated Case Report 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: Informed Consent Form

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: Clinical Study Report

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: Study Protocol

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

View Document

Related Links

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Other Identifiers

114496

Identifier Type: -

Identifier Source: org_study_id