Inhaled fluticasone propionate for chronic asthma

Abstract

Background: Inhaled fluticasone propionate (FP) is a relatively new inhaled corticosteroid for the treatment of asthma.

Objectives: 1. To assess efficacy and safety outcomes in studies that compared FP to placebo for treatment of chronic asthma. 2. To explore the presence of a dose-response effect.

Search strategy: We searched the Cochrane Airways Group Trial Register (1999), reference lists of articles, contacted trialists and searched abstracts of major respiratory society meetings (1997-1999).

Selection criteria: Randomised trials in children and adults comparing FP to placebo in the treatment of chronic asthma. Two reviewers independently assessed articles for inclusion and methodological quality.

Data collection and analysis: One reviewer extracted data. Quantitative analyses where undertaken using Review Manager 4.0.3 with MetaView 3.1.

Main results: 28 studies were selected for inclusion (5788 subjects). Methodological quality was high. In non-oral steroid treated asthmatics with mild-moderate disease FP produced improvements from baseline compared to placebo: FEV1 Weighted Mean Difference (WMD) 0.31 litres (95% confidence interval (CI) 0.27 to 0.36 litres); morning PEF WMD 29 /min (95% CI 24 to 33 L/min); symptom scores Standardised Mean Difference (SMD) 0.59 (95% CI 0.47 to 0.71); reduction in rescue beta2 agonist use WMD 1.1 puffs/d (95% CI 0.9 to 1.4). Similar effects were seen for all doses up to 1000 mcg/d. A shallow dose response effect was apparent: eg change in morning PEF with FP 1000 mcg/d WMD 49 L/min (95% CI 41 to 58 L/min). High dose FP reduced the number of patients dependent on prednisolone: FP 1000-1500 mcg/d Peto Odds Ratio 0.07 (95% CI 0.05 to 0.10). FP at all doses led to a greater likelihood of sore throat, hoarseness and oral Candidiasis.

Reviewer's conclusions: Doses of FP in the range 100-1000 mcg/d are effective. Although there appears to be a dose-response effect, in most patients with mild-moderate asthma improvements with low dose FP are only a little less than those with high doses. High dose FP appears to have worthwhile oral-corticosteroid reducing properties. FP use is accompanied by an increased likelihood of oropharyngeal side effects and this appears to be dose dependent.