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Title: Foradil Aerolizer (Formoterol) Improves Lung Function/Quality of Life In Chronic Obstructive Pulmonary Disease
URL: http://www.pslgroup.com/dg/207526.htm
Doctor's Guide
September 27, 2001


EAST HANOVER, NJ -- September 27, 2001 -- In the first head-to-head study between Foradil® Aerolizer™ (formoterol fumarate inhalation powder) and Atrovent® (ipratropium bromide), Foradil Aerolizer (12mcg twice daily) showed statistically significant (p < 0.025) improvement in lung function when compared with Atrovent (40mg four times daily).
The findings were published in the September issue of the American Journal of Respiratory and Critical Care Medicine.

In this study, while both Foradil Aerolizer and Atrovent were better than placebo in increasing lung function, Foradil Aerolizer was significantly better than Atrovent at opening the airways (bronchodilation) -- as early as five minutes after dosing and was still evident up to 12 hours. Compared with Atrovent, Foradil Aerolizer also significantly reduced symptoms (including the ability to perform usual daily activity, breathlessness over the past 24 hours, waking at night due to respiratory symptoms, breathlessness on rising, cough and sputum production), the frequency of 'bad days' (as self-reported in patient diaries), and the use of rescue medication.

"The goal of treating [chronic obstructive pulmonary disease] COPD is managing patients' symptoms throughout the course of the day," said Victor Marchione, M.D., FCCP, Director of Clinical Trials and Pulmonary Medicine at the Institute for Better Breathing in Jersey City, New Jersey.

"This study shows that Foradil Aerolizer taken twice daily provides better 24-hour symptom relief with reduced need for rescue medication. My clinical experience using Foradil Aerolizer in my COPD patients supports these research findings," he added. While not an investigator in this study, Dr. Marchione is familiar with these study results.

The multi-center, head-to-head, double-blind, placebo-controlled study was designed to compare the effectiveness of Foradil Aerolizer to Atrovent in 780 patients with COPD. In this study, both treatments appeared to have similar safety and tolerability profiles. The most frequent adverse events were viral infections, exacerbations of COPD, headache, upper respiratory tract infection, pharyngitis, chest pain, coughing and dyspnea, without significant differences between treatment groups.

"Results from this head-to-head study demonstrate that Foradil Aerolizer is an effective first-line therapy for COPD patients that can improve their quality of life," said Paulo Costa, President and Chief Executive Officer, Novartis Pharmaceuticals Corporation.

COPD, or "smoker's lung," is a smoking-related lung disease characterized by airflow obstruction, and includes chronic bronchitis and emphysema. Even though COPD is the fourth leading cause of death in the U.S., this disease remains under-diagnosed and under-treated. An estimated 30 to 35 million Americans may be suffering from COPD. Yet, just over half, or 16 million, of these sufferers have actually been diagnosed with the disease. Chronic obstructive pulmonary disease is a continuum that ranges from slight breathlessness to breathlessness bad enough to limit activities of daily living, such as getting dressed, walking up stairs and going shopping.

"Foradil Aerolizer eases bronchospasm -- opening the breathing passages in the lungs, allowing many patients with COPD to breathe easier," Dr. Marchione added.

The most frequent cause of COPD is a long history of smoking. Long-term smoking is the cause of 80 to 90 percent of all COPD cases. Other known causes are heredity, second-hand smoke, exposure to air pollution and a history of frequent lung infections. If not diagnosed and treated in its early stages, COPD can gradually progress to chronic hypoxemia (decreased oxygen in the blood), oxygen dependence, and in terminal stages, ventilator dependence and even death.

SOURCE: Novartis Pharmaceuticals Corporation



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