Placebo-controlled, comparative study of the efficacy and safety of triamcinolone acetonide inhalation aerosol with the non-CFC propellant HFA-134a in patients with asthma

Background: Triamcinolone acetonide (TAA) inhalation aerosol (Azmacort(R) I nhalation Aerosol), a well-established corticosteroid treatment for bronchi al asthma, utilizes the chlorofluorocarbon (CFC) propellant P-12, which wil l be phased out because of environmental concerns. Two TAA aerosol formulat ions have been developed using a non-chlorofluorocarbon propellant, HFA-134 a (Azmacort(R) HFA Inhalation Aerosol delivering TAA 75 mu g/puff or 225 mu g/puff). Objective: This study compared the efficacy and safety of the new 225 mu g/ puff formulation (TAA-HFA 225) to the marketed TAA inhalation aerosol (TAA- CFC) and to placebo in adult patients with moderate-to-severe persistent as thma, Methods: After a 5-day to 21-day baseline period during which all patients received TAA-CFC 150 mu g/day, 538 patients were randomized to one of the f ollowing treatment schedules: TAA-HFA 450, 900, or 1800 mu g/day; TAA-CFC 4 50 or 900 mu g/day; or placebo for 12 weeks. Results: All active treatment groups showed statistically significant impro vement compared with placebo in pulmonary function (FEV1, FEF25-75%, mornin g and evening PEF), use of rescue albuterol, and asthma symptom scores. Imp rovements in all variables occurred within 1 week of treatment. Conclusions: The TAA-HFA 225 exhibited similar safety and efficacy profiles to the two equivalent doses of TAA-CFC studied. Our findings indicate that TAA-HFA is a safe and effective replacement for the currently marketed CFC -containing product. The higher strength 225 mu g/puff formulation provides effective control of asthma with fewer inhalations.