HOME HELP FEEDBACK SUBSCRIPTIONS ARCHIVE SEARCH TABLE OF CONTENTS		QUICK SEARCH:   [advanced] Author: Keyword(s): Year:  Vol:  Page:
Guest Access | Sign In via User Name/Password

This Article Services Similar articles in this journal Alert me to new issues of the journal Download to citation manager Citing Articles Citing Articles via Google Scholar Google Scholar Articles by Hanania, N. Articles by Hanrahan, J. Search for Related Content PubMed Articles by Hanania, N. Articles by Hanrahan, J.

LONG-TERM SAFETY AND EFFICACY OF NEBULIZED ARFORMOTEROL IN SUBJECTS WITH COPD

Baylor College of Medicine, Houston, TX

PURPOSE:The long-term safety and efficacy of two long-acting β2-agonists (LABAs) arformoterol (administered via nebulization) and racemic formoterol DPI were compared in subjects with COPD in a multi-center, 6-month randomized, double-blind, double-dummy clinical trial.

METHODS:COPD subjects (mean FEV1 1.21 L, 41.0 % predicted) were randomized to receive either nebulized arformoterol (15µg BID [n=149]: 25µg BID [n=147]) or formoterol (12µg BID [n=147]). The primary endpoint was frequency of adverse events (AEs). Secondary endpoints included evaluation of pulmonary function and use of rescue medication.

RESULTS:The frequency of any adverse event for arformoterol 15 µg BID, 25 µg BID and racemic formoterol DPI 12 µg BID were 67.8%, 76.2% and 66.7%, respectively. The cumulative frequency of serious adverse events (SAEs) were 13.4%, 6.8%, and 9.5%, respectively, and 6.0%, 2.7%, and 4.1% for respiratory SAEs. Study discontinuations due to an AE occurred in 10.1%, 10.9%, and 8.2% of subjects in the 3 treatment groups, respectively. COPD exacerbations occurred in 31.5%, 29.3% and 22.4% of subjects, respectively. In all groups, exacerbations occurred with less frequency after 3- to 6-months of treatment compared with the first 3-months. Following the first study dose, mean FEV1AUC0–6 improved significantly from baseline for all treatment groups (arformoterol 15µg: 19.4%, 25 µg: 23.1%, formoterol: 16.9%). This improvement was sustained at 6-months (18.8%, 22.5%, and 16.2%; respectively). The 24-hour trough FEV1 also improved significantly for all treatment groups both after first dose (arformoterol 15µg: 14.9%, 25µg: 14.4%, formoterol: 14.1%) and at 6-months (10.2%, 13.4%, and 10.1%, respectively). Similarly, peak FEV1 improved significantly from baseline post-first dose (range: 26.3% to 32.3%), increases that were sustained at 6-months (range: 25.7% to 31.6%). Use of the short acting bronchodilators ipratropium and albuterol demonstrated significant decreases of -0.8 to -1.3 actuations/day for each of the treatments and remained stable over the entire 6-months.

CONCLUSION:In this study, all LABA treatments were well-tolerated, improved pulmonary function, and reduced short-acting inhaled bronchodilator use over 6-months.

CLINICAL IMPLICATIONS:Arformoterol and formoterol are effective maintenance bronchodilators in COPD subjects.Study supported by Sepracor Inc.

DISCLOSURE:Nicola Hanania, Consultant fee, speaker bureau, advisory committee, etc. Dr. Hanania participated in an Advisory Board meeting sponsored by Sepracor Inc.; No Product/Research Disclosure Information