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Quadrupling the Dose of Inhaled Corticosteroid to Prevent Asthma Exacerbations

A Randomized, Double-blind, Placebo-controlled, Parallel-Group Clinical Trial

¹ Division of Respiratory Medicine and ² Division of Epidemiology and Public Health, Respiratory Biomedical Research Unit, University of Nottingham, Nottingham, United Kingdom

Correspondence and requests for reprints should be addressed to Janet Oborne, Division of Respiratory Medicine, Respiratory Biomedical Research Unit, Clinical Sciences Building, City Hospital, Hucknall Road, Nottingham NG5 1PB, UK. E-mail: janet.oborne{at}nottingham.ac.uk

Rationale: Asthma exacerbations are unpredictable, disruptive, and frightening, and are therefore important to prevent.

Objectives: We investigated whether a policy of quadrupling the dose of inhaled corticosteroid when asthma control starts to deteriorate reduces asthma exacerbations requiring treatment with oral corticosteroids.

Methods: A total of 403 people with asthma were given a self-management plan and randomized to take an active or placebo corticosteroid inhaler in addition to their usual asthma treatment when their PEF fell by 15% on 2 consecutive days or by 30% on 1 day. The study inhalers provided a quadrupling or no change in corticosteroid dose.

Measurements and Main Results: Eighteen of 197 (9%) and 29 of 203 (14%) participants had an exacerbation of asthma requiring treatment with oral corticosteroids in the active and placebo groups, respectively, giving a risk ratio of 0.64 (95% confidence interval, 0.37–1.11, P = 0.11). Of the 94 participants who started the study inhaler far fewer required treatment with oral corticosteroids in the active compared with the placebo group: 12 of 56 (21%) in the active group and 19 of 38 (50%) in the placebo group, giving a risk ratio of 0.43 (95% confidence interval, 0.24–0.78, P = 0.004).

Conclusions: Although our primary outcome did not reach statistical significance, quadrupling the dose of inhaled corticosteroid when asthma control starts to deteriorate appears to reduce acute exacerbations of asthma and deserves further investigation.

Clinical trial registered with www.controlled-trials.com (ISRCTN 46018181).

Key Words: fourfold • steroids • asthma management

AT A GLANCE COMMENTARY Scientific Knowledge on the Subject Temporarily doubling the dose of inhaled corticosteroid at the time of deteriorating asthma control has been shown to be ineffective at preventing asthma exacerbations in two randomized controlled trials. Whether a more substantial increase in dose of inhaled corticosteroid when asthma control starts to deteriorate would be effective is not known. What This Study Adds to the Field Providing patients with asthma with a self-management plan incorporating a fourfold increase in dose of inhaled corticosteroid when asthma control starts to deteriorate may be effective at preventing exacerbations and deserves further investigation.

 

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