Does continuous use of inhaled corticosteroids improve outcomes in mild asthma? A double-blind randomised controlled trial

Abstract

Aim: To compare the effects of fluticasone and placebo on asthma control in patients with mild asthma.Method: Adults with FEV1 >80% predicted and reliever use <2 times/week were randomised to receive fluticasone 250 mcg/day or placebo double-blind for 11 months. Exacerbations were treated with four weeks' fluticasone 500 mcg/day. Primary outcomes were electronically-recorded morning PEF and FEV1, analysed by mixed model regression.Results: 44 subjects were randomised (23-fluticasone, 21-placebo). Fluticasone led to significantly better morning FEV1 (mean difference 5.4% predicted, p<0.0001), morning PEF, clinic spirometry, exhaled nitric oxide levels, and airway hyperresponsiveness, but there were no differences in reliever use, symptoms or quality of life. Fewer patients had mild exacerbations on fluticasone (22% vs 62%, p=0.02). Conclusion:The goals of asthma treatment include not only control of symptoms, but also prevention of future adverse outcomes such as exacerbations -which can occur even in mild asthma. This study showed that treatment with low dose inhaled corticosteroids led to significant improvements in lung function, exacerbations, and in pathophysiological predictors of future risk, even though symptoms were minimal at entry. For patients with mild asthma, discussion about treatment needs to consider not only short-term benefit, side effects and cost, but also long-term reduction of risk.This study was completed prior to mandatory registration for clinical trials.

Variability of methacholine bronchoprovocation and the effect of inhaled corticosteroids in mild asthma

“…This is in agreement with a meta-analysis including 11 studies in steroid-naive patients with mild asthma that did not show a dose–response effect, 7 but conflicts with a meta-analysis of 25 placebo-controlled trials evaluating the dose–response of ICS on AHR in patients with asthma with varying degrees of disease severity that concluded that higher doses of ICS produced greater improvement in AHR. 8 The lack of a consistent dose-dependent pattern of change in PC 20 in the present study could be because the treatment period with ICS was too short to affect AHR.…”

An Official American Thoracic Society/European Respiratory Society Statement: Asthma Control and Exacerbations

“…With ICS, significant between-group differences can be seen as early as 1 to 4 days (26,119,120). With electronic spirometric monitoring, significant between-group differences can be seen even in very mild asthma, where no differences in symptoms are detectable (121). Morning PEF continues to improve for around 2 to 3 months with ICS treatment (122,123).…”

Ventilation heterogeneity predicts asthma control in adults following inhaled corticosteroid dose titration

“…Symptoms can improve with increased ICS dose even if the FEV 1 is normal. 5 Although low FEV 1 at baseline is a predictor of poor asthma control in large longitudinal cohorts over several years, 6 it does not identify patients whose symptoms might recur in the weeks following Sacin: Ventilation heterogeneity in diffusion-dependent airways Scond: Ventilation heterogeneity in convection-dependent airways downtitration. 7 AHR may be clinically useful in predicting the symptom response following ICS dose adjustment.…”