Efficacy and safety of formoterol fumarate delivered by nebulization to COPD patients
Nicholas J Gross, Harold S Nelson, Robert J Lapidus, Leonard Dunn, Lon Lynn, Mike Rinehart, Kimberly Denis-Mize, Formoterol Study Group, Charles Andrews, Donald Auerbach, George Bensch, Shari Brazinsky, William Busse, B Lauren Charous, Edward Cordasco, Leonard Dunn, Charles Fogarty, Glenn Giessel, Gregory Gottschlich, Nicholas Gross, Edward Hines Jr, Thomas M Hyers, Harold Kaiser, Edward M Kerwin, Kenneth T Kim, Robert Lapidus, Lauro Lapuz, James F Lawless, Lydia Lawson, Irene P Leech, Bernard Levine, Mark Lindley, William Lumry, Lon Lynn, Frank P Maggiacomo, Manuel R Modiano, Anjuli Nayak, Harold Nelson, Michael Noonan, Parimal Parikh, Keith Popovich, Albert Razzetti, Mercedes Samson, Paul Scanlon, Thomas M Siler, Selwyn Spangenthal, Robert Sussman, Manuel S Villareal, Steven F Weinstein, Jan H Westerman, Bram D Wieskopf, Robert Wolfe, Richard ZuWallack, Nicholas J Gross, Harold S Nelson, Robert J Lapidus, Leonard Dunn, Lon Lynn, Mike Rinehart, Kimberly Denis-Mize, Formoterol Study Group, Charles Andrews, Donald Auerbach, George Bensch, Shari Brazinsky, William Busse, B Lauren Charous, Edward Cordasco, Leonard Dunn, Charles Fogarty, Glenn Giessel, Gregory Gottschlich, Nicholas Gross, Edward Hines Jr, Thomas M Hyers, Harold Kaiser, Edward M Kerwin, Kenneth T Kim, Robert Lapidus, Lauro Lapuz, James F Lawless, Lydia Lawson, Irene P Leech, Bernard Levine, Mark Lindley, William Lumry, Lon Lynn, Frank P Maggiacomo, Manuel R Modiano, Anjuli Nayak, Harold Nelson, Michael Noonan, Parimal Parikh, Keith Popovich, Albert Razzetti, Mercedes Samson, Paul Scanlon, Thomas M Siler, Selwyn Spangenthal, Robert Sussman, Manuel S Villareal, Steven F Weinstein, Jan H Westerman, Bram D Wieskopf, Robert Wolfe, Richard ZuWallack
Abstract
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 beta2-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 microg) or DPI (Foradil Aerolizer; FA 12 microg), 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<0.0001). No evidence of tachyphylaxis was observed as indicated by maintained FEV1 AUC and reduced rescue albuterol use throughout treatment. FFIS also significantly increased peak FEV1, trough FEV1, and standardized FVC AUC0-12h compared with placebo. SGRQ assessment at Week 12 demonstrated significant and clinically meaningful improvements in total score (FFIS vs placebo, -4.9, p=0.0067), symptom, and impact scores. No significant differences in efficacy were observed between the two active treatments. Drug related AEs in the FFIS arm with a frequency > or = 1% and exceeding placebo were dry mouth, nausea, and insomnia. Nebulized FFIS provided significant improvement in respiratory status and quality of life in subjects with COPD relative to placebo and was well tolerated. The efficacy and safety profile of FFIS was comparable to FA DPI.
Source: PubMed