Elsevier

The Lancet

Volume 363, Issue 9405, 24 January 2004, Pages 271-275
The Lancet

Articles
Doubling the dose of inhaled corticosteroid to prevent asthma exacerbations: randomised controlled trial

https://doi.org/10.1016/S0140-6736(03)15384-6Get rights and content

Summary

Background

Asthma self-management plans that include doubling the dose of inhaled corticosteroid when the condition deteriorates improve asthma control. Whether doubling the dose of corticosteroid in isolation is effective is unknown. We undertook a randomised controlled trial to investigate the effects of doubling the dose of inhaled corticosteriods when asthma deteriorates.

Methods

390 individuals with asthma who were at risk of an exacerbation monitored their morning peak flow and asthma symptoms for up to 12 months. When peak flow or symptoms started to deteriorate, participants added an active or placebo corticosteroid inhaler to their usual corticosteroid for 14 days to produce a doubling or no change in dose. The primary outcome was the number of individuals starting oral prednisolone in each group.

Findings

During 12 months, 207 (53%) started their study inhaler and 46 (12%) started prednisolone—22 (11%) of 192 and 24 (12%) of 198 in the active and placebo groups, respectively. The risk ratio for starting prednisolone was therefore 0·95 (95% CI 0·55–1·64, p=0·8).

Interpretation

We recorded little evidence to support the widely recommended intervention of doubling the dose of inhaled corticosteroid when asthma control starts to deteriorate.

Introduction

Asthma guidelines recommend regular inhaled corticosteroid treatment for patients with persistent asthma and daily symptoms needing β-agonist treatment.1, 2 In patients with symptomatic but fairly stable asthma, doubling3, 4 or quadrupling5 the dose of inhaled corticosteroid leads to modest changes in spirometry and peak flow. Doubling the dose of inhaled corticosteroid when asthma control deteriorates is widely advocated but is of unproven value. We aimed to investigate whether doubling the dose of inhaled corticosteroid when asthma control starts to deteriorate reduces the number of patients needing prednisolone, and to establish the effect on the severity and duration of the subsequent exacerbation.

Section snippets

Patients

We recruited individuals aged 16 years and older with a clinical diagnosis of asthma and taking an inhaled corticosteroid (100 to 2000 μg per day) on a regular basis from local general practices and our asthma research register. To be included, individuals had to have taken a course of oral corticosteroids or doubled their dose of inhaled corticosteroid temporarily in the previous 12 months to treat or prevent an asthma exacerbation. Exclusion criteria were history of smoking of more than 10

Results

Table 1 shows details of 390 participants who fulfilled the entry criteria and were randomly allocated to provide two well matched treatment groups. 17 and 20 individuals withdrew from the active and placebo groups, respectively (ten and 11 were lost to follow-up, three and seven for personal reasons, and four and two on the advice of their general practitioner [figure 1]). About half (207) started the study inhaler; almost 60% in the active group and about 50% in the placebo group. Of the 207

Discussion

We have recorded little evidence to lend support to the widely recommended intervention of doubling the dose of inhaled corticosteroid when asthma control starts to deteriorate. When compared with placebo, doubling the dose of inhaled corticosteroid had no effect on the number of patients needing prednisolone, lowest peak flow recorded, rise in symptom scores, highest symptom score recorded, or time to recovery for peak flow and symptom scores. The fall in peak flow while taking the study

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