Aerovance Inc. announced that it has received clearance from the U.S. Food and Drug Administration (FDA) and the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) to initiate Aerovance's Phase IIb clinical trial, AeroTrial, of inhaled dry powder Aerovant in patients with uncontrolled asthma.
Study initiation began this week in the United States 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 United States 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 (1 mg, 3 mg or 10 mg) 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by inhalation twice daily for 12 weeks, during which time their standard ICS and LABA therapies will be gradually withdrawn.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 (PEF) and symptom scores, immunoglobulin E (IgE) levels, and fractional concentration of expired nitric oxide (FeNO).