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

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ClinicalTrials.gov Identifier: NCT01431950

Recruitment Status : Completed

First Posted : September 12, 2011

Results First Posted : September 3, 2014

Last Update Posted : January 9, 2017

Sponsor:

Information provided by (Responsible Party):

GlaxoSmithKline

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Asthma	Drug: fluticasone furoate Drug: albuterol/salbutamol	Phase 3

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	238 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	A Randomised, Double-blind, Multi-centre Study to Evaluate the Efficacy and Safety of Inhaled Fluticasone Furoate in the Treatment of Persistent Asthma in Adults and Adolescents Currently Receiving Mid to High Strength Inhaled Corticosteroids.
Study Start Date :	September 2011
Actual Primary Completion Date :	October 2012
Actual Study Completion Date :	October 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma Steroids

Drug Information available for: Fluticasone propionate Fluticasone Fluticasone furoate

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: FF 100mcg once daily Inhaled corticosteroid (ICS)	Drug: fluticasone furoate Inhaled corticosteroid Drug: albuterol/salbutamol Provided as rescue relief of asthma symptoms
Experimental: FF 200mcg once daily Inhaled corticosteroid	Drug: fluticasone furoate Inhaled corticosteroid Drug: albuterol/salbutamol Provided as rescue relief of asthma symptoms

Outcome Measures

Primary Outcome Measures :

Change From Baseline in Clinic Visit Evening (Pre-bronchodilator and Pre-dose) Forced Expiratory Volume in One Second (FEV1) at the End of the 24-week Treatment Period [ Time Frame: Baseline and Week 24 ]
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Evening clinic visit FEV1 is defined as the clinic visit (pre-bronchodilator and pre-dose) FEV1 measurement taken at the Week 24 clinic visit. Pre-dose and pre-rescue albuterol/salbutamol trough FEV1 were measured electronically by spirometry in the evening at the Baseline through Week 24 clinic visits. The highest of 3 technically acceptable measurements was recorded. Baseline was the pre-dose value obtained at Visit 2. Change from Baseline was calculated as the Week 24 value minus the Baseline value. Analysis was performed using analysis of covariance (ANCOVA) with covariates of Baseline, region, sex, age, and treatment. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing, pre-dose, post-Baseline on-treatment measurement at scheduled clinic visits was used to impute the missing value.

Secondary Outcome Measures :

Change From Baseline in the Percentage of Rescue-free 24-hour (hr) Periods Over the 24-week Treatment Period [ Time Frame: From Baseline up to Week 24 ]
The number of inhalations of rescue bronchodilator, albuterol/salbutamol inhalation aerosol, used during the day and night was recorded by the participants in a daily electronic diary (eDiary). A 24-hour period in which a participant's responses to both the morning and evening assessments indicated no use of rescue medication was considered to be rescue free. A 24-hour period was considered as missing if both day time and night time values were missing or if one of the day time or night time values were missing and the other value indicated no use of rescue medication. The Baseline value is the average of the values over the last 7 days of the daily eDiary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 24-week Treatment Period minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.
Change From Baseline in Daily Evening (PM) Peak Expiratory Flow (PEF) Averaged Over the 24-week Treatment Period [ Time Frame: From Baseline up to Week 24 ]
PEF is a measure of lung function and is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each morning and evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Change from Baseline (defined as the average of the values of the last 7 days prior to randomization of the participants) was calculated as the value of the averaged daily trough PM PEF over the 24-week Treatment Period minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.
Change From Baseline in Daily Morning (AM) PEF Averaged Over the 24-week Treatment Period [ Time Frame: From Baseline up to Week 24 ]
PEF is a measure of lung function and is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each morning and evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Change from Baseline (defined as the average of the values of the last 7 days prior to randomization of the participants) was calculated as the value of the averaged daily AM PEF over the 24-week Treatment Period minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.
Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods Over the 24-week Treatment Period [ Time Frame: From Baseline up to Week 24 ]
Asthma symptoms were recorded in a daily eDairy by the participants every day in the morning and evening before taking any rescue or study medication and before the peak expiratory flow measurement. A 24-hour period in which a participant's responses to both the morning and evening assessments indicated no symptoms was considered to be symptom free. A 24-hour period was considered as missing if both the day time and night time data were missing or if one was symptom-free but the other was missing. The Baseline value was the average of the values of the last 7 days of the daily eDiary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 24-week Treatment Period minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.

Eligibility Criteria

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Ages Eligible for Study:	12 Years to 100 Years (Child, Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01431950

Locations

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United States, California
GSK Investigational Site
Long Beach, California, United States, 90808
GSK Investigational Site
Newport Beach, California, United States, 92663
United States, Colorado
GSK Investigational Site
Colorado Springs, Colorado, United States, 80907
United States, Florida
GSK Investigational Site
Clearwater, Florida, United States, 33756
United States, Georgia
GSK Investigational Site
Albany, Georgia, United States, 31707
United States, Kentucky
GSK Investigational Site
Lexington, Kentucky, United States, 40503
United States, Louisiana
GSK Investigational Site
Metairie, Louisiana, United States, 70006
GSK Investigational Site
Sunset, Louisiana, United States, 70584
United States, Maryland
GSK Investigational Site
Bethesda, Maryland, United States, 20814
United States, Minnesota
GSK Investigational Site
Plymouth, Minnesota, United States, 55441
United States, Nevada
GSK Investigational Site
Las Vegas, Nevada, United States, 89119
United States, New Jersey
GSK Investigational Site
Brick, New Jersey, United States, 08724
United States, New York
GSK Investigational Site
Utica, New York, United States, 13502
United States, Ohio
GSK Investigational Site
Canton, Ohio, United States, 44718
GSK Investigational Site
Cincinnati, Ohio, United States, 45242
GSK Investigational Site
Toledo, Ohio, United States, 43617
United States, Oklahoma
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73103
United States, South Carolina
GSK Investigational Site
Orangeburg, South Carolina, United States, 29118
United States, Texas
GSK Investigational Site
Corsicana, Texas, United States, 75110
Argentina
GSK Investigational Site
Ciudad Autonoma de Buenos Aires, Argentina, C1425BEN
GSK Investigational Site
Ciudad Autónoma de Buenos Aires, Argentina, C1121ABE
GSK Investigational Site
Ciudad Autónoma de Buenos Aires, Argentina, C1426ABP
GSK Investigational Site
Mendoza, Argentina, M5500CCG
GSK Investigational Site
San Miguel de Tucumán, Argentina, 4000
Chile
GSK Investigational Site
Puente Alto - Santiago, Región Metro De Santiago, Chile, 8207257
GSK Investigational Site
Santiago, Región Metro De Santiago, Chile, 7500800
GSK Investigational Site
Valparaiso, Valparaíso, Chile, 2341131
France
GSK Investigational Site
Aigrefeuille Sur Maine, France, 44140
GSK Investigational Site
Bourg Des Comptes, France, 35890
GSK Investigational Site
Chalons en Champagne, France, 51000
GSK Investigational Site
Laon, France, 02000
GSK Investigational Site
Nantes, France, 44300
GSK Investigational Site
Vannes, France, 56000
Mexico
GSK Investigational Site
Villahermosa, Tabasco, Mexico, 86100
GSK Investigational Site
Mexico City, Mexico, 07760
Russian Federation
GSK Investigational Site
Belgorod, Russian Federation, 308007
GSK Investigational Site
Kazan, Russian Federation, 420015
GSK Investigational Site
Novokuznetsk, Russian Federation, 654063
GSK Investigational Site
Penza, Russian Federation, 440067
GSK Investigational Site
Pyatigorsk, Russian Federation, 357538

Sponsors and Collaborators

GlaxoSmithKline

Investigators

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Study Director:	GSK Clinical Trials	GlaxoSmithKline

More Information

Additional Information:

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