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| |  New Combivent Combines Two Bronchodilators For Bronchitis, Emphysema RIDGEFIELD, Conn., June 17, 1997 -- Combivent(R) (ipratropium bromide and albuterol sulfate) Inhalation Aerosol, a preparation that combines two widely prescribed medicines in a single, convenient metered dose inhaler is now available to treat chronic obstructive pulmonary disease (COPD), known collectively as chronic bronchitis and emphysema. Combivent Inhalation Aerosol is indicated for use in patients with COPD on a regular aerosol bronchodilator who continue to have evidence of bronchospasm (spasmodic airway muscle contraction) and who require a second bronchodilator to widen, or dilate, constricted airways, i.e., the tubes carrying air to the lungs. "Combivent Inhalation Aerosol not only offers patients dosing convenience, it also combines the rapid symptom relief of albuterol with the increased bronchodilation and longer action of ipratropium," said Thomas L. Petty, MD, Professor of Medicine, University of Colorado Health Sciences Center, Denver. "Because the average wholesale cost is less for Combivent Inhalation Aerosol than for two separate inhalers*, patients should also be able to save money," he added. COPD is a progressive, debilitating, and life-threatening respiratory disease that affects more than 16 million Americans and, according to the American Lung Association, accounted for nearly 96,000 deaths in 1993, making it the fourth leading cause of death in the United States. Tobacco smoking is the sole identifiable cause in 80 percent to 90 percent of cases, and COPD patients commonly have a smoking history of 20 or more cigarettes a day for 20 years.(2) Clinical Trials Combivent(R) (ipratropium bromide and albuterol sulfate) Inhalation Aerosol has been compared with each of its components administered alone, or with a commercially available preparation of albuterol, in four large, double-blind, randomized, multicenter clinical trials. Combivent Inhalation Aerosol delivered the same doses of ipratropium and albuterol as were delivered separately by each of the single-drug inhalers. One of these trials was a 12-week study involving 534 COPD patients given Combivent Inhalation Aerosol, ipratropium bromide, or albuterol sulfate. Combivent Inhalation Aerosol achieved an average increase in FEV1 -- a standard measure of lung function -- that was 16 percent to 30 percent greater than the increase with ipratropium alone and 18 percent to 28 percent greater than the increase with albuterol alone.(4) (FEV1 is the volume of air a patient can forcefully exhale in one second after a full inhalation.) The Combivent Inhalation Aerosol group maintained a statistically significant increase in FEV1 over ipratropium bromide or albuterol sulfate alone from day 1 through day 85. Combivent Inhalation Aerosol has a strong safety profile and showed no potentiation of side effects over either single component alone. In 12-week controlled clinical trials, the most frequently reported adverse events for Combivent Inhalation Aerosol (n=358), ipratropium bromide (n=362) and albuterol sulfate (n=347) were bronchitis: 12.3 percent, 12.4 percent and 17.9 percent; upper respiratory tract infection: 10.9 percent, 12.7 percent and 13.0 percent; and headache: 5.6 percent, 3.9 percent and 6.6 percent, respectively. The recommended dosing for Combivent is two puffs four times a day. Patients may take additional puffs as needed to control respiratory symptoms, but the total number of puffs should not exceed 12 in 24 hours. Safety and efficacy of additional doses Combivent or extra doses of ipratropium bromide or albuterol sulfate in addition to recommended doses of Combivent have not been studied. The Relentless Progression of COPD COPD develops over a period of years but produces no visible symptoms in the early years of the disease. As the disease progresses, lung function declines at an accelerated rate -- faster than the decline that normally accompanies aging -- and symptoms, such as cough or breathlessness, begin to appear. Many people give little thought to these symptoms, dismissing them as "smokers cough" or attributing them to "just getting old." If the symptoms are brought to a doctor's attention, however, and COPD is diagnosed, therapy can be started. Smoking cessation is the essential first step in treating the disease. Combivent Inhalation Aerosol is available by prescription only and is a product of original research at Boehringer Ingelheim Pharmaceuticals Inc., Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, Connecticut, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation (Ridgefield, Conn.).
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