Efficacy and safety of formoterol fumarate delivered by nebulization to COPD patients

Summary Nebulized solutions of long-acting bronchodilators provide an alternative to DPI and MDI delivery, particularly for COPD patients unable to use hand-held devices easily or correctly. The long-acting β2 -agonist, formoterol fumarate, is differentiated by its onset of significant bronchodilation within 5 min of administration. In a randomized, double-blind, double-dummy trial, COPD subjects ( n =351, mean forced expiratory volume FEV1 =1.3 L, 44% predicted) received nebulized formoterol fumarate (Perforomist™ inhalation solution; FFIS 20 μg) or DPI (Foradil® Aerolizer® ; FA 12 μg), or placebo twice daily for 12 weeks. Efficacy was assessed with 12-h pulmonary function tests, and quality of life was assessed before and after treatment with the St. George's Respiratory Questionnaire (SGRQ). At the 12-week endpoint, FFIS significantly increased FEV1 AUC0–12h relative to placebo ( p