A comparator study to assess safety and efficacy of Flutiform® compared with symbicort turbohaler in asthma patients with moderate to severe persistent, reversible asthma.
This is a study involving a 2-4 week run-in phase followed by a 12 week double blind treatment phase. During the run-in phase, subjects receive Flixotide®. In the treatment phase subjects will be randomised to one of the two treatment groups and will receive either FlutiForm® and placebo inhaler for symbicort® turbohaler® or symbicort® turbohaler® and placebo inhaler for Flutiform ® . Efficacy will be assessed by lung function tests, asthma symptoms, sleep disturbance due to asthma and rescue medication use. Safety will be assessed by adverse events, lab tests, ECGs and vital signs.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
261
inhaler 2 puffs bd daily
2 puffs bd daily
Unnamed facility
Sofia, Bulgaria
Csongrád Megyei Önkormányzat Mellkasi Betegségek Szakkórháza Tüdőgondozó Intézet
Szeged, Hungary
Unnamed facility
Indore, India
Unnamed facility
Krakow, Poland
Unnamed facility
Brasov, Romania
non-inferiority in the efficacy of FlutiForm®
To show non-inferiority in the efficacy of FlutiForm® pMDI 125/5 µg (2 puffs bid) vs Symbicort® Turbohaler® 200/6 µg (2 puffs bid), based on the mean change in the pre morning dose value of forced expiratory volume in the first second (FEV1) from baseline (end of run-in period) to the end of the 12 week treatment period.
Time frame: baseline to the end of the 12 week treatment
Additional efficacy and safety assessments
efficacy assessments include patient centered outcome assessments such as asthma quality of life questionnaire, subject's assessment of study medication, amount of rescue medication use, asthma symptom scores, sleep disturbance due to asthma, discontinuations due to lack of efficacy, compliance with study medication use \& asthma exacerbations. Post dose FEV1, peak expiratory flow rates \& other lung function parameters. Safety assessments include incidence \& type of spontaneously reported adverse events, vital signs, laboratory tests and 12-lead ECGs.
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