Asthma Clinical Trial
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.
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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