A Cochrane review [Abstract] 1 included 86 studies with a total of 16 160 subjects. Methodological quality was high. In non-oral steroid treated asthmatics with mild and moderate disease fluticasone propionate (FP) resulted in improvements from baseline compared with placebo across all dose ranges (100 to 1000 mcg/d) in FEV1 (between 0.1 to 0.43 litres); morning PEF (between 23 and 46 l/min); symptom scores (based on a standardised scale, between 0.44 and 0.7); reduction in rescue beta-2 agonist use (between 1 and 1.4 puffs/day). High dose FP reduced the number of patients dependent on prednisolone: FP 1000-1500 µg/d Peto Odds Ratio 14.07 (95% CI 7.17 to 27.57). FP at all doses led to greater likelihood of sore throat, hoarseness and oral candidiasis.
Another Cochrane review 2 (abstract , review [Abstract]) included 51 studies (representing 55 group comparisons) with a total of 10 797 participants. Methodological quality was high. In asthmatics with mild to moderate disease who were not on oral steroids, FP did not exhibit a dose-response effect in the lower dose comparisons in FEV1 (50 µg, 100 µg, 200 µg and 4-500 µg daily). There were no statisitically significant differences between 4-500 µg and 800-1000 µg, and between 50-100 and 800-1000 µg of FP. When 200 µg was compared with 800-1000 µg daily FEV1 favoured the four/five fold increase. For PEF, a dose response was present with FP when low and moderate, and low and high doses of FP were compared. There was no dose-response effect on symptoms or rescue beta-2 agonist use. The likelihood of hoarseness and oral candidiasis was significantly greater for the higher doses (800 to 1000 µg/day). People with oral steroid-dependent asthma treated with FP (2000 µg/day) were significantly more likely to reduce oral prednisolone than those on 1000 to 1500 µg/day (OR 2.8, 95% CI 1.3 to 6.3). The highest dose also allowed a significant reduction in daily oral prednisolone dose compared to 1000 to 1500 µg/day (WMD 2.0 mg/day, 95% CI 0.1 to 4.0 mg/day).
Primary/Secondary Keywords