Evaluating the Efficacy and Safety of Fluticasone Furoate in the Treatment of Asthma in Adults and Adolescents
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
238 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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