High strength extrafine pMDI beclometasone/formoterol (200/6 µg) is effective in asthma patients not adequately controlled on medium-high dose of inhaled corticosteroids

This was a randomized, double-blind study that evaluated the efficacy and safety of beclometasone/formoterol via pMDI versus beclomethasone in 376 adult asthma patients who were inadequately controlled on high- or medium-dose inhaled corticosteroids plus a LABA. The primary endpoint was change in average pre-dose morning PEF; secondary endpoints were pre-dose evening PEF, PEF daily variability, pre-dose clinic FEV1, rescue medication usage, day- and night-time symptom scores, proportion of asthma control days, ACQ score, and rate of moderate/severe exacerbations. Patients used a Vitalograph In2itive e-Diary to measure and record daily pre-dose morning and evening PEF, and to record daily rescue and study medication usage, and symptom scores for cough, wheeze, chest tightness, and breathlessness.