Effects of 2 weeks of treatment with fluticasone propionate 100 mcg b.d. by comparison with zafirlukast 20 mg b.d. on bronchial hyper-responsiveness in patients with mild to moderate asthma.

This study was designed to compare the effects of low-dose inhaled fluticasone propionate (100 mcg twice daily) with those of the leukotriene antagonist, zafirlukast (20 mg twice daily), on bronchial hyper-responsiveness. The study recruited 30 patients (nine men, 21 women; mean age 45 years) with forced expiratory volume in 1 sec (FEV1) > 50% and airway reversibility to salbutamol > or =15%. This was a single centre, double-blind, double-dummy cross-over study, composed of two successive 2-week treatment periods, each preceded by a 2-4 week single-blind placebo period. Following 2 weeks of treatment with fluticasone propionate and zafirlukast, the mean provocational concentration causing a 20% fall in FEV1 (PC20) histamine was 1.61 mg ml(-1) (SD 2.34) and 0.99 mg ml(-1) (SD 1.74) respectively. Taking baseline differences into account, the difference between treatments was equivalent to 0.77 doubling doses of histamine (95% CI, 0.05-1.50; P=0.037). Morning peak flow values were significantly higher (17 l min(-1); P=0.049) after treatment with fluticasone propionate during the second week of treatment. Both treatments were well tolerated. The results of this short-term study show that compared with zafirlukast, a low dose of fluticasone propionate offers greater clinical benefit and is more cost effective.

RCT Entities:   Population Interventions Outcomes