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The Effect of High-Dose Inhaled Beclomethasone Dipropionate in Patients With Stable COPD^*

^* From the Department of Respiratory Medicine, Graduate School of Medicine (formerly the Chest Disease Research Institute), Kyoto University, Sakyo-ku, Kyoto, Japan.

Background: The benefits of inhaled corticosteroids in the management of COPD are less apparent than they are in asthma therapy, and the potential for adverse systemic effects of high-dose inhaled corticosteroids has been recognized recently. It is therefore essential to know the maximal obtainable benefits in order to assess the risk/benefit ratio of this treatment.

Purpose: The aim of this study was to investigate the maximal obtainable benefits of high-dose inhaled corticosteroids, 3 mg/d of beclomethasone dipropionate (BDP), when used in combination with adequate doses of regular bronchodilators in patients with stable COPD.

Study Design: Thirty patients with stable COPD completed a randomized, double-blind, placebo-controlled cross-over trial with either 3 mg/d of BDP or with a matching placebo using a metered-dose inhaler with a spacer device for 4 weeks during each treatment period. All of the patients continued to inhale both 400 µg of salbutamol qid and 80 µg of ipratropium bromide qid.

Results: The mean prebronchodilator FEV₁ was 0.97 ± 0.35 L during the placebo period and 1.08 ± 0.38 L during the BDP period (p < 0.001). While on BDP, five patients demonstrated a response in their FEV₁ of more than 8.5% of the predicted value, which was above the range that covered 95% of the distribution of the placebo response. The mean absolute improvement in the FEV₁ in these 5 objective responders was 0.34 ± 0.10 L, compared to 0.06 ± 0.09 L in the 25 objective nonresponders. Symptom scores for wheezing and dyspnea were significantly better with BDP than with placebo. Hoarseness and sore throat were associated more with BDP treatment.

Conclusion: Although a considerable minority of patients benefited substantially from this treatment, the overall outcome does not seem to justify the widespread use of this treatment in the light of increasing recognition of the potential adverse systemic effects of high-dose inhaled corticosteroids.

Key Words: beclomethasone dipropionate • COPD • corticosteroid

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