This novel approach to therapy is intended to provide the same efficacy as the currently marketed nebulizer product, but with a lower dose delivered in less time.
The phase II clinical trial will assess the efficacy of two doses of Map0010 and will be conducted at multiple clinical sites in the US as a randomized, double-blind, placebo-controlled study in approximately 225 pediatric and adolescent asthma patients.
The primary endpoint for the study will be asthma control, as assessed by changes in daily and evening asthma symptoms (coughing, wheezing, breathlessness) compared to placebo, with secondary endpoints that will evaluate changes in pulmonary function. Safety evaluations will be made throughout the duration of the clinical trial period.
“We are optimistic that the unique features of our proprietary formulation will demonstrate significant delivery advantages and rapid therapeutic benefit to patients over existing asthma treatments,” said Dr Stephen Shrewsbury, vice president of clinical and regulatory affairs at Map.