Efficacy of Inhaled Steroids (Beclomethasone Dipropionate) for Treatment of Mild to Moderately Severe Asthma in the Emergency Department: A Randomized Clinical Trial,☆☆,,★★

Presented at the Annual Meeting of the Royal College of Physicians and Surgeons of Canada, Canadian Association of Emergency Physicians, September 1995, Montréal, Québec, Canada.
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Abstract

Study objective: To examine the efficacy of an inhaled steroid, when added to a standard regimen of β-agonist therapy, in the treatment of patients with mild to moderately severe asthma in the emergency department. Methods: A convenience sample of adult patients with asthma (FEV1 %predicted 40% to 69%) presenting to the ED was randomly assigned in a double-blind fashion into 2 treatment groups. The first group received 2.5 mg nebulized salbutamol plus 1 mg (4 puffs) of beclomethasone dipropionate (BDP) at baseline, 30 minutes, and at 1, 2, and 4 hours, delivered by a metered-dose inhaler (MDI) attached to a spacer device (Vent-AH-aler, Glaxo). The second group was given the same salbutamol regimen plus MDI placebo through the Vent-AH-aler. The primary endpoint was improvement in FEV1 %predicted at 6 hours. Results: Of 54 patients enrolled, 28 were assigned to the BDP group and 26 to the placebo group. Spirometry improved significantly in both groups over the 6 hours compared with baseline (ANOVA, P <.001). At 6 hours, the mean absolute improvement in FEV1 %predicted for BDP was 18% versus 17% for placebo (95% confidence interval for the absolute difference of 1% [–8% to 10%]). The proportion of patients in the BDP group who were hospitalized was 7% compared with 19% for patients in the placebo group (95% confidence interval for the difference of 12% [–6%, 30%]). Conclusion: In this group of patients with mild to moderately severe asthma, 5 mg BDP delivered by MDI during the initial 4 hours of an emergency visit was of no added benefit over standard therapy, as measured by improvement in FEV1 %predicted at 6 hours. However, a trend toward a difference in admission favoring BDP was observed. [Afilalo M, Guttman A, Colacone A, Dankoff J, Tselios C, Stern E, Wolkove N, Kreisman H: Efficacy of inhaled steroids (beclomethasone dipropionate) for treatment of mild to moderately severe asthma in the emergency department: A randomized clinical trial. Ann Emerg Med March 1999;33:304-309.]

Section snippets

INTRODUCTION

In acute severe asthma exacerbations, systemic steroids are considered an essential component of treatment.1 Corticosteroids have been shown to be effective in speeding recovery and reducing the number of hospitalizations.2 The most common methods of steroid administration in the emergency department are the intravenous and oral routes.

Inhaled steroids, routinely used to treat chronic refractory asthma, have demonstrated an oral steroid–sparing effect, permitting some patients to reduce or even

METHODS AND MATERIALS

Patients who presented to the ED of the Sir Mortimer B. Davis–Jewish General Hospital with acute asthma5 and who met the following inclusion criteria were enrolled in the study: (1) 18 years of age or older, (2) able to perform spirometry, (3) FEV1 %pred 40% to 69%, and (4) written informed consent. Patients were excluded if any of these criteria were met: (1) patient in extremis, (2) long-term systemic steroid therapy (>1 month) within the last 6 months, (3) use of high-dose inhaled steroids

RESULTS

As shown in the trial profile (Figure 1), 54 patients were enrolled in the study; 28 were randomly assigned to the BDP group and 26 to the placebo group.

. Trial profile.

Included in the intention-to-treat analyses were 3 patients who discharged themselves early (BDP=1, placebo=2), and 2 patients (BDP=1, placebo=1) who were withdrawn from the protocol because of worsening respiratory status. There was never an occasion to break any code during the trial. No other asthma medications were given

DISCUSSION

Asthma is primarily an inflammatory disease on which bronchospasm is superimposed.9 Guidelines emphasize that therapy must be geared toward managing both the bronchoconstriction, as well as the inflammatory component of the disease.1 As a result, this has led to recommendations for the early use of steroids in acute asthma.1 Inhaled steroids are increasingly used in the outpatient management of asthma, and are preferred over the systemic route because of their better therapeutic index. In

Acknowledgements

The authors acknowledge the diligent work and support of the emergency physicians and nurses in the realization of this project.

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Supported by a grant from Glaxo Canada and the Brownstein Endowment Fund. Dr Kreisman has participated in symposia and postgraduate courses funded by Glaxo Canada.

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Address for reprints: Marc Afilalo, MD, MCFP(EM), FRCP(C), Director Emergency Department, Sir Mortimer B. Davis–Jewish General Hospital, 3755 Chemin Côte Ste. Catherine, Room D-012, Montréal, Québec, H3T 1E2, Canada.

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