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Initial Improvements in Lung Function and Bronchial Hyperresponsiveness Are Maintained During 5 Years of Treatment With Inhaled Beclomethasone Dipropionate and Terbutaline^*

W. Rob Douma, PhD; Huib A. M. Kerstjens, PhD; Ad de Gooijer, MD; Shelley E. Overbeek, PhD; Gerard H. Koëter, PhD and Dirkje S. Postma, PhD; the Dutch Chronic Nonspecific Lung Disease Study Group

^* From the Department of Pulmonology (Drs. Douma, Kerstjens, Koëter, and Postma), University Hospital Groningen, Groningen; the Intensive Care Unit (Dr. de Gooijer), Hospital Gelderse Vallei, Ede; and the Department of Pulmonology (Dr. Overbeek), University Hospital Rotterdam, Rotterdam, the Netherlands. A complete list of participants is given in the ^Appendix.

Correspondence to: Dirkje S. Postma, PhD, University Hospital Groningen, Department of Pulmonology, Hanzeplein 1, 9713 GZ Groningen, the Netherlands

Objectives: Treatment with inhaled corticosteroids reduces bronchial hyperresponsiveness and relieves airways obstruction in patients with asthma. Up to now, it is unknown whether initial improvements are maintained over a long period of time. Therefore, we assessed whether initial improvements in FEV₁, provocative concentration of histamine causing a 20% fall in FEV₁ (PC₂₀), and peak expiratory flow (PEF) persist with a constant dose of inhaled corticosteroids. Furthermore, we investigated whether FEV₁, PC₂₀, PEF indexes, and symptom scores improve after increasing the dose of inhaled corticosteroids in patients who did not respond sufficiently to treatment with beclomethasone dipropionate (BDP), 800 µg/d.

Methods: Sixty-eight patients with bronchial hyperresponsiveness and airways obstruction completed a previous study on 3 years of treatment with terbutaline, 500 µg qid, and BDP, 200 µg qid. Fifty-eight of these patients participated in the current extension of another 2.5 years of follow-up. Every 6 months, FEV₁ and PC₂₀ were measured. Five patients dropped out of the study, one for pulmonary reasons. Forty-four patients continued treatment with BDP, 800 µg/d (BDP-800 group), and 9 patients received a higher dose of BDP (500 µg tid; BDP-1,500 group) after the first 3 years because of a rapid decline in FEV₁ (> 50 mL/yr) despite BDP treatment during the previous study period.

Results: After the initial improvement, the mean slope of individual regression lines for FEV₁, PC₂₀, and morning PEF were - 28 mL/yr, - 0.01 doubling concentrations per year, and 0.6 L/min/yr, respectively, in the BDP-800 group. In the BDP-1,500 group, there were no statistically significant improvements in FEV₁, PC₂₀, PEF indexes, and symptom scores after increasing the dose of BDP.

Conclusions: We conclude that initial improvements in FEV₁, PC₂₀, and PEF are well preserved over 5 years in patients with obstructive airways diseases who are treated with terbutaline and BDP. In the patients who responded sufficiently to 800 µg/d of BDP, there was no accelerated decline in FEV₁ compared with the general population. Increasing the dose of BDP in a small group of patients with an accelerated fall in FEV₁ (initially treated with a moderate dose of BDP) resulted in no significant improvement in FEV₁, PC₂₀, PEF indexes, and symptom scores.

Key Words: inhaled corticosteroids • long-term study • obstructive airways disease

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