Background In a previous study, we found that two years of treatmentwith an inhaled corticosteroid, budesonide, was more effectivethan treatment with an inhaled 2-agonist, terbutaline, in patientswith newly diagnosed, generally mild asthma. We continued thisstudy for a third year to investigate whether the steroid dosecould be reduced or discontinued and what effect crossover ofpatients from 2-agonist therapy to corticosteroid therapy wouldhave.
Methods A total of 37 patients treated for two years with inhaledbudesonide at a dose of 1200 µg per day were randomlyassigned to treatment with 400 µg of budesonide per day(19 patients) or placebo (18 patients) in a double-blind manner.Another 37 patients, who had received terbutaline during thefirst two years, were crossed over in an open-label manner totreatment with 1200 µg of budesonide per day during thethird year.
Results Treatment with the reduced dose of budesonide was sufficientlyeffective in 74 percent of the patients to maintain bronchialresponsiveness at a level similar to that achieved with thehigher dose. In contrast, improvement was maintained in only33 percent of the patients receiving placebo, and the differencesin pulmonary function between the steroid and placebo groupswere significant (for forced expiratory volume in one second,P = 0.007; for bronchial responsiveness to histamine, P = 0.025;and for peak expiratory flow in the morning, P = 0.040). Thecondition of patients who were crossed over from terbutalinetherapy to treatment with 1200 µg of budesonide per dayimproved. However, the degree of improvement in these patientsappeared to be less than in those who were treated with budesonideat the beginning of the three-year study.
Conclusions Early treatment with inhaled budesonide resultsin long-lasting control of mild asthma. Maintenance therapycan usually be given at a reduced dose, but discontinuationof treatment is often accompanied by exacerbation of the disease.
Source Information
From Helsinki University Central Hospital, Helsinki, Finland (T.H., K.K., A.S., B.S.-A., L.A.L.); Kanta-Hame Central Hospital, Hameenlinna, Finland (M.J.); Pohjois-Karjala Central Hospital, Joensuu, Finland (T.K.); Kiljava Hospital, Kiljava, Finland (S.K., R.T.); Etela-Saimaa Central Hospital, Lappeenranta, Finland (K.L.); and Astra Draco AB, Lund, Sweden (K.N., T.P., O.S., T.S.).
Address reprint requests to Dr. Haahtela at the Department of Allergic Diseases, Helsinki University Central Hospital, Meilahdentie 2, SF-00250 Helsinki, Finland.
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