PURPOSE: In patients of bronchial asthma not adequately controlled by inhaled corticosteroids (ICS) alone, the addition of long acting beta agonists is recommended. We evaluated the safety and efficacy of a new HFA propelled pressurized metered dose inhaler (pMDI) containing a combination of Fluticasone and Formoterol compared to the combination of Budesonide/Formoterol.
METHODS: This was a multicenter randomized double-blind parallel group study. There was a 2-4 week run in period during which patients received 400 mcg budesonide daily. Those who were inadequately controlled were randomized to receive a combination inhaler containing Fluticasone/Formoterol (FF) 125/6 mcg or Budesonide/Formoterol (BF) 200/6 mcg, 2 inhalations twice a day, both through an HFA pMDI for a period of 12 weeks. The primary end point was morning peak expiratory flow rate (mPEFR).
RESULTS: There were 232 patients, 137 males and 95 females. The mean age was 41.4 years. Baseline characteristics were similar in both groups. At the end of 12 weeks, improvement in mPEFR were similar in both groups, 48.07 L/m in the FF group and 49.03 L/m in the BF group, a difference of -0.96 L/m (CI: -5.6 to +0.46). Mean changes in Forced expiratory Volume in 1 second (FEV1) were also similar (0.19 L in the FF group and 0.20 L in the BF group). Improvements in symptoms, rescue medication and evening PEFR were also similar. Adverse events occurred in 10.2% of patients in the FF group and 8.7% in the BF group. 2 patients in the BF group discontinued the study, 1 due to worsening of asthma and another due to a fracture.
CONCLUSION: Fluticasone/Formoterol combination is as effective and as well tolerated as Budesonide/Formoterol in patients with bronchial asthma.
CLINICAL IMPLICATIONS: The combination of Fluticasone/Formoterol HFA pMDI is a new option in the treatment of patients with bronchial asthma not adequately controlled by ICS alone.
DISCLOSURE: Jaideep Gogtay, Employee I am a full time employee of Cipla Ltd; Other The study was supported by Cipla Ltd; No Product/Research Disclosure Information