A 12 week, randomized, double-blind, multicenter, active controlled, 2-arm parallel group study testing the superiority of CHF 1535 pMDI 800/24μg total daily dose (fixed combination of
extrafine beclomethasone dipropionate plus formoterol fumarate) compared to CHF 718 pMDI 800μg total daily dose (extrafine beclomethasone dipropionate) in adults with asthma on medium
or high-dose inhaled corticosteroid.
Criteria:· Age of patient: 18-75 (inclusive)
· A documented history of asthma for at least 1 year, with onset before age 40
· Use of medium-dose ICS with or without a LABA or high dose ICS alone for 3 months
· Subjects with a pre-bronchodilator FEV1 ≥40% and ≤85% of predicted, after appropriate washout from bronchodilators
· Reversibility of at least 12% on their lung function tests within 30 minutes after 4 inhalations of albuterol