The drug, MAP0005, is a combination of a corticosteroid and a long-acting beta2-agonist delivered to the respiratory tract using MAP Pharmaceuticals’ Tempo inhaler.
The primary endpoints of the trial are the change in forced expiratory volume in one second (FEV1) from baseline, the time to maximum change in FEV1 and the plasma levels for the inhaled corticosteroid.
The Phase IIa clinical trial is a randomized, open-label, active-controlled, crossover, safety and dose response study investigating the pharmacokinetics and pharmacodynamics of MAP0005 in approximately 18 adult asthmatic patients. The trial compares two different doses of MAP0005 with one dose of a commercially marketed combination product, all administered by inhalation.
Map Pharmaceuticals believes that by combining drugs at the micron or submicron particle level, rather than as separate particles, as practiced with current inhaled combination therapies, the synergistic effect of the drugs can be enhanced leading to increased dosing efficiency and consistency.