Aerovance, a biopharmaceutical company, has received clearance from the FDA and the UK Medicines and Healthcare products Regulatory Agency to initiate its Phase IIb clinical trial, AeroTrial, of inhaled dry powder Aerovant in patients with uncontrolled asthma.
Study initiation has begun in the US for AeroTrial, a double-blind, randomized, placebo-controlled, Phase IIb dose-ranging study. Aerovance expects to enroll approximately 500 patients with moderate to severe asthma, in the US and Europe, who are poorly controlled by the combination of inhaled corticosteroids (ICS) and long-acting beta agonists (LABA).
Patients will be randomly assigned to receive one of three Aerovant doses (1mg, 3mg or 10mg) or placebo by inhalation twice daily for 12 weeks, during which time their standard ICS and LABA therapies will be gradually withdrawn.
The primary endpoint is exacerbation incidence on Aerovant therapy as compared to placebo. Secondary endpoints include pulmonary function, time to exacerbation, daily peak expiratory flow and symptom scores, immunoglobulin E levels, and fractional concentration of expired nitric oxide.
Mark Perry, president and CEO of Aerovance, said: Regulatory clearance and initiation of AeroTrial are significant milestones for Aerovance and potentially for patients living with uncontrolled asthma. The efficacy and safety data from our completed Aerovant studies are promising, and we are pleased to begin evaluation of this compound in a large number of moderate to severe asthmatics.