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Background Treatment guidelines recommend the regular use of inhaled corticosteroids for patients with mild persistent asthma. We investigated whether the symptom-driven use of a combination of beclomethasone dipropionate and albuterol (also known as salbutamol) in a single inhaler would be as effective as the regular use of inhaled beclomethasone and superior to the as-needed use of inhaled albuterol.
Methods We conducted a 6-month, double-blind, double-dummy, randomized, parallel-group trial. After a 4-week run-in, patients with mild asthma were randomly assigned to receive one of four inhaled treatments: placebo twice daily plus 250 µg of beclomethasone and 100 µg of albuterol in a single inhaler as needed (as-needed combination therapy); placebo twice daily plus 100 µg of albuterol as needed (as-needed albuterol therapy); 250 µg of beclomethasone twice daily and 100 µg of albuterol as needed (regular beclomethasone therapy); or 250 µg of beclomethasone and 100 µg of albuterol in a single inhaler twice daily plus 100 µg of albuterol as needed (regular combination therapy). The primary outcome was the morning peak expiratory flow rate.
Results In 455 patients with mild asthma who had a forced expiratory volume in 1 second of 2.96 liters (88.36% of the predicted value), the morning peak expiratory flow rate during the last 2 weeks of the 6-month treatment was higher (P=0.04) and the number of exacerbations during the 6-month treatment was lower (P=0.002) in the as-needed combination therapy group than in the as-needed albuterol therapy group, but the values in the as-needed combination therapy group were not significantly different from those in the groups receiving regular beclomethasone therapy or regular combination therapy. The cumulative dose of inhaled beclomethasone was lower in the as-needed combination therapy group than in the groups receiving regular beclomethasone therapy or regular combination therapy (P<0.001 for both comparisons).
Conclusions In patients with mild asthma, the symptom-driven use of inhaled beclomethasone (250 µg) and albuterol (100 µg) in a single inhaler is as effective as regular use of inhaled beclomethasone (250 µg twice daily) and is associated with a lower 6-month cumulative dose of the inhaled corticosteroid. (ClinicalTrials.gov number, NCT00382889
[ClinicalTrials.gov]
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Source Information
From Università di Ferrara, Ferrara (A.P.); Università di Genova, Genoa (G.W.C.); Università di Padova, Padua (P.M.); Università di Pisa, Pisa (P.P.); Università di Parma (D.O.) and Chiesi Farmaceutici (G.N.) — both in Parma; Università di Pavia, Pavia (E.P.); Università di Catania, Catania (N.C.); Università di Palermo, Palermo (A.M.V.); Contract Research Organization Statistics and Data Management, Verona (P.M.); and Università di Modena, Modena e Reggio Emilia, Modena (L.M.F.) — all in Italy.
Dr. Vignola is deceased.
Address reprint requests to Dr. Fabbri at Clinica di Malattie dell'Apparato Respiratorio, Dipartimento di Oncologia, Ematologia e Pneumologia, Università di Modena e Reggio Emilia, Largo del Pozzo, 71-41100 Modena, Italy, or at fabbri.leonardo{at}unimore.it.
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