Clinical efficacy and safety of fluticasone propionate 1 mg per day administered via a HFA 134a pressurized metered dose inhaler to patients with moderate to severe asthma. International study group.

摘要: This multi-national, double-blind, randomized, parallel-group study compared the efficacy and tolerability of fluticasone propionate 500 microg twice daily propelled either by non-chlorofluorocarbon (CFC) propellant, hydrofluoroalkane (HFA) 134a, or CFC propellants 11 12 used in established pressurized metered dose inhaler (pMDI). The period was months involved 412 subjects with moderate to severe asthma (HFA 134a pMDI: n = 203; 209). For first 3 months, kept a record card attended clinic every 4 weeks. Thereafter, they diaries for 2 weeks before each assessment, which were performed at end 6, 9 months. Mean morning peak expiratory flow (PEF) increased during week both treatment groups. By adjusted mean increase from baseline PEF 21 23 l min(-1) HFA pMDI groups, respectively, this maintained throughout 12-month period. Similar improvements detected other diary parameters lung function measurements. two groups shown be clinically equivalent terms all variables there no differences tolerability. There few reports low serum cortisol levels period, similar after In conclusion, new is as effective safe when dosage 1 mg day(-1).