The purpose of the present study is to demonstrate the higher efficacy of Foster® NEXThaler® 100/6 extra fine (two inhalations b.i.d.) versus Seretide® Accuhaler® 250/50 (one inhalation b.i.d.), in terms of pulmonary function (change from baseline to the end of treatment in post-dose peripheral airway resistance) in patients with asthma.
Asthma is a chronic inflammatory disease characterised by variable airflow obstruction and bronchial hyper responsiveness. Asthma affects both the large and the small airways and there is a growing body of evidence that small airways impairment is an important contributor to the pathogenesis and clinical expression of the disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
108
Foster® NEXThaler® (beclomethasone dipropionate 100 µg plus formoterol 6 µg per actuation), 2 inhalations b.i.d. (daily dose of BDP 400 µg plus FF 24 µg)
Seretide® Accuhaler® (fluticasone propionate 250 μg plus salmeterol xinafoate 50 μg per actuation), 1 inhalation b.i.d. (daily dose of fluticasone 500 μg plus salmeterol 100 μg)
Dipartimento Cardio-Polmonare - Azienda Ospedaliero-Universitaria - Padiglione Rasori
Parma, Italy
Change from baseline to end of treatment in post-dose peripheral airway resistance [R(5Hz)-R(20Hz)].
Time frame: Baseline and 3 months
Changes from baseline at each clinic visit in pre and post-dose Impulse Oscillometry (IOS)/plethysmographic/spirometric parameters
Time frame: After 4, 8, 12 weeks of treatment
Asthma exacerbations (severe)
Time frame: Up to 12 weeks of treatment
Clinical measures of asthma control
Time frame: Up to 12 weeks of treatment
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