Revolutionary Inhaler Treats COPD

The inhaler has a status window whose color changes from red to green when a dose has been effectively delivered, and registers an audible click at the same time. A faint taste lingers to further confirm dose delivery. A dose indicator warns patients when only 10 doses remain and the device locks out when its 30-day supply is exhausted to prevent patients continuing to inhale dry-powder residue that lacks active medication.

The inhaler is currently in two parallel phase III trials that have recruited 1600 patients. Data from an earlier phase IIa study showed a single dose of aclidinium bromide provides a rapid and long-acting bronchodilatory effect, significantly improving lung function over 24 hours. The drug is also being developed in a fixed-dose combination with the long-acting beta agonist formoterol and in combination with an as-yet-undisclosed inhaled corticosteroid. The new inhaler is being developed by Almirall (Barcelona, Spain).

"We think aclidinium bromide will be a real star - a jewel in our crown,” said Dr. Gozalo de Miguet, Almirall's global research and development (R&D) medical director. "No patients have withdrawn from clinical trials on account of side effects.”

Aclidinium bromide is an anticholinergic that has a strong selectivity for the M3 receptor in the airway and dissociates very slowly from it. In vitro, aclidinium bromide demonstrates comparable anticholinergic action to other antimuscarinic drugs, tiotropium and ipratropium, but acts faster than tiotropium and works for longer than ipratropium. This results in a sustained bronchodilator effect that improves measures of lung function such as forced expiratory volume in 1 second (FEV1).


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