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Volume 337:1405-1411 November 13, 1997 Number 20 Next

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ABSTRACT

Background The role of long-acting, inhaled ₂-agonists in treating asthma is uncertain. In a double-blind study, we evaluated the effects of adding inhaled formoterol to both lower and higher doses of the inhaled glucocorticoid budesonide.

Methods After a four-week run-in period of treatment with budesonide (800 µg twice daily), 852 patients being treated with glucocorticoids were randomly assigned to one of four treatments given twice daily by means of a dry-powder inhaler (Turbuhaler): 100 µg of budesonide plus placebo, 100 µg of budesonide plus 12 µg of formoterol, 400 µg of budesonide plus placebo, or 400 µg of budesonide plus 12 µg of formoterol. Terbutaline was permitted as needed. Treatment continued for one year; we compared the frequency of exacerbations of asthma, symptoms, and lung function in the four groups. A severe exacerbation was defined by the need for oral glucocorticoids or a decrease in the peak flow to more than 30 percent below the base-line value on two consecutive days.

Results The rates of severe and mild exacerbations were reduced by 26 percent and 40 percent, respectively, when formoterol was added to the lower dose of budesonide. The higher dose of budesonide alone reduced the rates of severe and mild exacerbations by 49 percent and 37 percent, respectively. Patients treated with formoterol and the higher dose of budesonide had the greatest reductions — 63 percent and 62 percent, respectively. Symptoms of asthma and lung function improved with both formoterol and the higher dose of budesonide, but the improvements with formoterol were greater.

Conclusions In patients who have persistent symptoms of asthma despite treatment with inhaled glucocorticoids, the addition of formoterol to budesonide therapy or the use of a higher dose of budesonide may be beneficial. The addition of formoterol to budesonide therapy improves symptoms and lung function without lessening the control of asthma.

Source Information

From the Department of Respiratory Diseases, University Hospital, Ghent, Belgium (R.A.P.); the Department of Respiratory Medicine, University Hospital, Lund, Sweden (C.-G.L.); the Division of Respiratory Disease, University Hospital, Groningen, the Netherlands (D.S.P.); the Division of Respiratory Medicine, City Hospital, Nottingham, United Kingdom (A.E.T.); the Department of Respirology, McMaster University, Hamilton, Ont., Canada (P.O.); the National Heart and Lung Institute, Imperial College, London (P.J.B.); and Clinical Research and Development, Astra Draco, Lund, Sweden (A.U.).

Address reprint requests to Dr. Pauwels at the Department of Respiratory Diseases, University Hospital, De Pintelaan 185, B9000 Ghent, Belgium.

Full Text of this Article

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Effect of Inhaled Formoterol and Budesonide on Exacerbations of Asthma
FitzGerald J. M., Salvi S., Pauwels R. A., Tattersfield A. E., Löfdahl C.-G.
Extract | Full Text  
N Engl J Med 1998; 338:1071-1073, Apr 9, 1998. Correspondence

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