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CFC-free Azmacort Just As Effective As Existing Formulation BERLIN, GERMANY -- September 25, 1997 -- Three new studies demonstrate the new chloroflurocarbon (CFC)-free formulation of the asthma treatment Azmacort(R) (triamcinolone acetonide) is just as safe and effective as the existing CFC formulation. The studies included 1,525 patients, both adults and children and confirm that Azmacort CFC-free is a suitable alternative to the CFC-containing formulation, the top-selling inhaled bronchial steroid in the United States. The studies were presented at the European Respiratory Society meeting in Berlin. The first study was presented by Dr. Jacques Caldwell, M.D., medical director of the Halifax Clinical Research Center in Daytona, Florida. This double-blind, placebo-controlled study included 514 adult patients with moderate asthma and was intended to establish the dose-related efficacy of Azmacort CFC-free, using the current formulation as a reference. After removal from their usual inhaled corticosteroid treatment during a baseline of five to 21 days, patients received placebo or total daily doses of 150, 300 and 600 mcg of CFC-free Azmacort, as one, two or four puffs twice daily for eight weeks. Both formulations of Azmacort produced significant dose-related improvements over placebo, with no serious adverse events. These improvements were seen in daily symptom scores, pulmonary function assessment and the use of a beta-agonist(A) (salbutamol) to control asthma. The second study was a double-blind, placebo-controlled study, whose goal was to determine the efficacy and safety of the current CFC formulation of Azmacort, at a dose of 75 mcg per puff and of the CFC-free formulation at a dose of 225 mcg per puff. This study, led by Dr. Paul Chervinsky, M.D., president of the New England Research Center in North Dartmouth, Massachusetts, included 538 adult patients with moderate to moderately-severe asthma from 45 centers in the United States. After a baseline period of five to 21 days of daily treatment with 150 mcg CFC-formulation Azmacort, patients received total daily doses of 450 or 900 mcg of Azmacort CFC formulation (three or six puffs, 100 mcg twice daily), 450, 900 or 1,800 mcg of Azmacort CFC-free (one, two or four puffs, 225 mcg twice daily), or placebo, for 12 weeks. Both formulations were significantly more active than placebo in terms of forced expiratory volume in one second (FEV1)(B) and use of beta-agonists. No serious adverse events related to Azmacort, CFC-free or the original formulation, were reported. The last study, also presented by Dr. Chervinsky, was a double-blind, dose-ranging, multicenter study, whose goal was to compare the efficacy of Azmacort CFC-formulation with Azmacort CFC-free in 473 children aged six to 12 years, from 45 centers in the United States. Patients were randomly given either Azmacort or Azmacort CFC-free at doses of 150, 300 or 600 mcg per day (one, two and four puffs twice daily) for 12 weeks. When comparing FEV1 and the use of beta-agonists, there were no significant differences between Azmacort and Azmacort CFC-free. Both formulations were efficacious and their efficacy increased over the dose range. Both formulations were well tolerated and were not associated with any serious adverse events. In clinical trials with Azmacort, the most commonly reported side effects were pharyngitis, hoarseness, dry and irritated throat and dry mouth. As with all inhaled bronchial steroids, adrenal insufficiency may occur when transferring patients from systemic steroids. Asthma is a chronic inflammatory condition that affects at least 13 million Americans -- including 4.8 million children -- and can be life-threatening, the risk being considerably higher for poorly managed patients. It accounts for an estimated three million lost workdays annually and is the number one cause of absenteeism from school and hospitalization among children. In the European Union it is estimated five percent of the population suffers from asthma. According to a study published in 1992, the prevalence of asthma in adults in most industrialized countries varies from three to seven percent and there is evidence from many countries that this prevalence is rising E-mail this page to a friend or colleague! To print, use this version