BROVANA(TM) (Arformoterol Tartrate) Inhalation Solution Study Data Presented at American College of Chest Physicians Annual Conference
October 23, 2006 07:00:28 (ET)
MARLBOROUGH, Mass., Oct 23, 2006 (BUSINESS WIRE) -- Sepracor Inc. (SEPR, Trade) today announced that it presented data from a Phase III pivotal trial of BROVANA(TM) (arformoterol tartrate) Inhalation Solution at CHEST 2006, the annual meeting of the American College of Chest Physicians (ACCP), in Salt Lake City.
Efficacy and Safety of Nebulized Arformoterol in COPD: A Prospective Phase III Clinical Trial
Results of a double-blind, randomized, placebo-controlled multi-center Phase III study that included 739 adult patients with chronic obstructive pulmonary disease (COPD) were presented. The study evaluated airway function improvement with BROVANA and salmeterol (SEREVENT(R)) metered-dose inhaler compared with placebo over a period of 12 weeks in patients with COPD.
"In this study, treatment with nebulized BROVANA resulted in rapid bronchodilation and maintenance improvement, providing beneficial therapeutic effects for patients with COPD," said William J. Calhoun M.D., Sealy and Smith Distinguished Professor of Internal Medicine; Director, Division of Allergy, Pulmonary, Immunology, CCM, and Sleep at the University of Texas Medical Branch, Galveston, Texas. "We've successfully used nebulizers for many patients with pulmonary diseases for years, and I'm excited that BROVANA received FDA approval, making it the first nebulized long-acting bronchodilator for use in COPD."
Patients treated with BROVANA demonstrated clinically meaningful and statistically significant improvement in morning trough FEV1 throughout the 12-week study period versus patients administered placebo. Morning trough FEV1 refers to the measure of forced expiratory volume in one second, obtained just prior to the morning dose. At Week 0, representing the first day of treatment, patients treated with BROVANA 15 mcg demonstrated mean percent improvement in morning trough FEV1 change from baseline of 21.8% versus 6.3% for those administered placebo (p<0.001). At Week 12, patients treated with BROVANA 15 mcg showed a mean percent improvement in morning trough FEV1 change from baseline of 14% versus 4.7% for those administered placebo (p=0.003).
In the study, the percentage of patients in the BROVANA 15 mcg treatment group who achieved improvement in FEV1 that was greater than or equal to 10% from predose was 88.3% versus 55.1% for patients administered placebo, at Week 0. The median time to achieve this response was 3.3 minutes in the BROVANA 15 mcg group and 213.7 minutes for those administered placebo. At Week 12, 84.3% of patients administered BROVANA 15 mcg demonstrated a 10% or greater increase in FEV1 while 40.7% of patients in the placebo group achieved a 10% or greater improvement in FEV1. At Week 12, the median time to achieve this response was 10.0 minutes for the BROVANA 15 mcg group and not applicable for the placebo treatment group, given that less than 50% of subjects responded. BROVANA was well tolerated in this study. |
