A controlled trial of chlorofluorocarbon-free triamcinolone acetonide inhalation aerosol in the treatment of adult patients with persistent asthma

Study objective: To compare the dose response, efficacy, and safety of inha led triamcinolone acetonide (TAA) with a hydrofluoroalkane (HFA) propellant (75 mu g/puff), TAA with a chlorofluorocarbon propellant (dichlorodifluoro methane [P-12]; 75 mu g/puff), and placebo in adult patients with persisten t asthma. Design: Multicenter, randomized, double-blind, placebo-controlled parallel- group study of 514 adult patients with persistent asthma. Interventions cmd measurements: Patients received 8 weeks of treatment with 150, 300, or 600 mu g/d of TAA. HFA, the same doses of TAA P-12, or placeb o following a 5- to 21-day baseline period. Efficacy was assessed by spirom etry, and by daily recordings of albuterol use, peak expiratory flow (PEF), asthma symptom ratings, and nighttime awakenings throughout the study. Results: Linear trend analysis showed that both formulations of TAA at all doses produced statistically significant improvements compared with placebo in spirometry, asthma symptom scores, albuterol use, and PEF. Significant improvement was seen as early as 24 h for morning PEF and as early as 1 wee k for FEV1 (TAA HFA, 600 mu g/d; TAA P-12, 300 and 600 mu g/d) and albutero l use (all doses of both formulations). The P-12 and HFA formulations had c omparable efficacy A dose response showing greater improvement with higher doses was evident for the majority of parameters for both formulations. The incidences of adverse events were similar across all treatment groups with no dose-related trends. Conclusion: HFA and P-12 formulations of TAB inhalation aerosol were therap eutically equivalent and showed comparable safety and dose-related efficacy in the treatment of patients with persistent asthma.