Long-term safety of a non-chlorofluorocarbon-containing triamcinolone acetonide inhalation aerosol in patients with asthma

In response to environmental concerns regarding chlorofluorocarbon (CFC), t wo new triamcinolone acetonide (TAA) inhalation aerosol (Azmacort Inhalatio n Aerosol) formulations have been developed using a more environmentally fa vorable propellant, HFA-134a (1,1,1,2-tetrafluoroethane). This multicenter, open-label study evaluated the safety of switching asthma patients from TA A-CFC to one of two TAA-HFA formulations. After a 2- or 4-week baseline per iod during which patients received only CFC-containing TAA Inhaler, 552 pat ients were randomized to receive TAA-HFA 75 or 225 mu g for 6 or 12 months. A total of 493 patients completed treatment. Seven patients discontinued b ecause of adverse events and two because of ineffective asthma control. The incidence of adverse events was similar in the two treatment groups, and m ost events were mild to moderate in severity and were not considered relate d to study medication. No clinically relevant suppression of the hypophysea l-pituitary-adrenal (HPA) axis was observed. Pulmonary function tests were not adversely affected by use of either study medication, and improvements were noted in forced expiratory volume in 1 sec (FEV1) and forced expirator y flow between 25% and 75% of forced vital capacity (FEF25%-75%) throughout the course of treatment. This study confirms that TAA-HFA provides effecti ve, long-term asthma control and can safely be substituted for the currentl y marketed CFC-containing TAA product.