Clinical trial NCT01431950: Evaluating the Efficacy and Safety of Fluticasone Furoate in the Treatment of Asthma in Adults and Adolescents
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: fluticasone furoate
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-09-12
Enrollment: 238
Sex: ALL
Minimum age (years): 12
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 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
timeFrame: Baseline and Week 24
Secondary outcomes:
measure: Change From Baseline in the Percentage of Rescue-free 24-hour (hr) Periods Over the 24-week Treatment Period
timeFrame: From Baseline up to Week 24
measure: Change From Baseline in Daily Evening (PM) Peak Expiratory Flow (PEF) Averaged Over the 24-week Treatment Period
timeFrame: From Baseline up to Week 24
measure: Change From Baseline in Daily Morning (AM) PEF Averaged Over the 24-week Treatment Period
timeFrame: From Baseline up to Week 24
measure: Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods Over the 24-week Treatment Period
timeFrame: From Baseline up to Week 24
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: GSK Investigational Site
state: California
city: Newport Beach
country: United States
facility: GSK Investigational Site
state: California
city: Colorado Springs
country: United States
facility: GSK Investigational Site
state: Colorado
city: Clearwater
country: United States
facility: GSK Investigational Site
state: Florida
city: Albany
country: United States
facility: GSK Investigational Site
state: Georgia
city: Lexington
country: United States
facility: GSK Investigational Site
state: Kentucky
city: Metairie
country: United States
facility: GSK Investigational Site
state: Louisiana
city: Sunset
country: United States
facility: GSK Investigational Site
state: Louisiana
city: Bethesda
country: United States
facility: GSK Investigational Site
state: Maryland
city: Plymouth
country: United States
facility: GSK Investigational Site
state: Minnesota
city: Las Vegas
country: United States
facility: GSK Investigational Site
state: Nevada
city: Brick
country: United States
facility: GSK Investigational Site
state: New Jersey
city: Utica
country: United States
facility: GSK Investigational Site
state: New York
city: Canton
country: United States
facility: GSK Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: GSK Investigational Site
state: Ohio
city: Toledo
country: United States
facility: GSK Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: GSK Investigational Site
state: Oklahoma
city: Orangeburg
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Corsicana
country: United States
facility: GSK Investigational Site
state: Texas
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: GSK Investigational Site
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: GSK Investigational Site
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: GSK Investigational Site
city: Mendoza
country: Argentina
facility: GSK Investigational Site
city: San Miguel de Tucumán
country: Argentina
facility: GSK Investigational Site
city: Puente Alto - Santiago
country: Chile
facility: GSK Investigational Site
state: Región Metro De Santiago
city: Santiago
country: Chile
facility: GSK Investigational Site
state: Región Metro De Santiago
city: Valparaiso
country: Chile
facility: GSK Investigational Site
state: Valparaíso
city: Aigrefeuille Sur Maine
country: France
facility: GSK Investigational Site
city: Bourg Des Comptes
country: France
facility: GSK Investigational Site
city: Chalons en Champagne
country: France
facility: GSK Investigational Site
city: Laon
country: France
facility: GSK Investigational Site
city: Nantes
country: France
facility: GSK Investigational Site
city: Vannes
country: France
facility: GSK Investigational Site
city: Villahermosa
country: Mexico
facility: GSK Investigational Site
state: Tabasco
city: Mexico City
country: Mexico
facility: GSK Investigational Site
city: Belgorod
country: Russian Federation
facility: GSK Investigational Site
city: Kazan
country: Russian Federation
facility: GSK Investigational Site
city: Novokuznetsk
country: Russian Federation
facility: GSK Investigational Site
city: Penza
country: Russian Federation
facility: GSK Investigational Site
city: Pyatigorsk
country: Russian Federation
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.