Current issues of ACP Journal Club are published in Annals of Internal Medicine


Therapeutics

Inhaled budesonide improved airway responsiveness and reduced asthma severity in nonsteroid-dependent asthma

ACP J Club.1991 Jan-Feb;114:3. doi:10.7326/ACPJC-1991-114-1-003


Source Citation

Juniper EF, Kline PA, Vanzieleghem MA, et al. Effect of long-term treatment with an inhaled corticosteroid (budesonide) on airway hyperresponsiveness and clinical asthma in nonsteroid-dependent asthmatics. Am Rev Respir Dis. 1990;142:832-6.


Abstract

Objective

To evaluate whether prolonged use of inhaled corticosteroid leads to full recovery from airway hyperresponsiveness among stable, adult asthmatics requiring bronchodilators alone.

Design

Randomized, double-blind, controlled trial of budesonide (200 µg twice daily) compared with placebo inhalations (twice daily) for 1 year.

Setting

Regional chest and allergy clinic and university medical center in Hamilton, Ontario, Canada.

Patients

32 adult asthmatics were selected from those attending a referral pulmonary clinic. Inclusion criteria included airway hyper-responsiveness to methacholine aerosol and current asthma symptoms that were controlled on 800 µg or less salbutamol daily. Patients were excluded if they had used inhaled or oral steroids or cromoglycate within 6 weeks of starting the study, or if they were nursing, pregnant, or not reliably protected from pregnancy. 91% completed the study.

Intervention

Patients received budesonide, a potent inhaled corticosteroid, 200 µg twice daily (n = 16), or a placebo aerosol (n = 16), both given with a 750-mL spacing device.

Main outcome measures

Patients attended monthly clinics for assessments of airway responsiveness to methacholine and of clinical asthma severity. Severity was measured by bronchodilator use, questionnaire, and the number of asthma exacerbations requiring additional therapy.

Main results

Patients treated with budesonide showed a 4-fold improvement in airway responsiveness to methacholine compared with a small worsening for those treated with placebo (P < 0.001). Improved airway responsiveness was seen in 15 of 16 patients (94%) who were prescribed budesonide. {This absolute risk improvement of 56% means that 2 patients would need to be treated with budesonide (compared with placebo) to improve airway responsiveness in 1 additional patient, 95% CI 1 to 4; The relative risk improvement was 150%, CI 46% to 411%.}* 5 of the 15 patients treated with budesonide had some inprovement in airway responsiveness to the normal range. The greatest improvements in responsiveness occurred in the first 3 months and increased with time. In comparison with patients treated with placebo, patients prescribed budesonide showed reduction in asthma severity on questionnaire (P < 0.009), used bronchodilators less (P < 0.05), and had fewer asthma exacerbations (P < 0.001). No serious adverse effects were observed.

Conclusion

Regular use of inhaled budesonide by nonsteroid-dependent asthmatics improved airway responsiveness and reduces asthma severity.

Source of funding: Astra Pharma Inc.

Address for article reprint: Professor E. F. Juniper, McMaster University Medical Center, 1200 Main Street West, Hamilton, Ontario, Canada L8N 3Z5.

*Numbers calculated from data in article.


Commentary

The treatment of asthma and chronic lung disease is undergoing rapid change. Preventive therapy for asthma has traditionally been aimed at the bronchial spastic component of the disease. Current research suggests that the focus should now be shifted to anti-inflammatory drugs. The benefit of this type of therapy is highlighted by the demonstration that airway hyperresponsiveness, thought to be central to the genesis of asthmatic attacks, can be greatly diminished by the use of inhaled steroid medications. Most clinical trials of anti-inflammatory therapy in asthma have been relatively short (less than 8 weeks) (1). The advantages of the current study include the length of the trial (1 year) and the detailed assessment of disease severity with multiple methods. Despite the performance of the trial in a referral center, the patient population appears generalizable to most clinical practices. Physicians should consider prescribing inhaled steroids along with bronchodilators from the earliest phases of therapeutic intervention for adults with asthma.

Scott T. Weiss, MD, MS
Channing LaboratoryBoston, Massachusetts, USA


Reference

1. Jenkins CR, Woolcock AJ. Effect of prednisone and bedomethasone diproprionate on airway responsiveness in asthma: a comparative study. Thorax. 1988;43:378-84.