Symptomatic use of beclomethasone plus albuterol and regular use of beclomethasone did not differ for control of mild asthma.

نویسنده

P John Rees

چکیده

M e t h o d s Design: Randomized controlled trial (Beclomethasone plus Salbutamol Treatment [BEST] study). Allocation: Unclear allocation concealment.* Blinding: Blinded (unclear).* Follow-up period: 6 months. Setting: 25 centers in Italy, Austria, Poland, and Spain. Patients: 466 patients, 18 to 65 years of age, with mild, persistent asthma for ≥ 6 months, prebronchodilator FEV1≥ 75% of predicted value, and controlled asthma during 4-week run-in (beclomethasone, 250 μg, twice daily plus albuterol, 100 μg, as needed). Exclusion criteria included current or past smoker (> 10 packs/y), chronic obstructive pulmonary disease, history of serious asthma (near-fatal or hospitalization in past 1 y), ≥ 3 courses of oral corticosteroids, and > 6 months of regular treatment with beclomethasone, ≥ 500 μg/d, or equivalent. Intervention: 4 groups: 2 groups with placebo twice daily plus either as-needed combination therapy (n = 124) or as-needed control therapy (albuterol, 100 μg, n = 119); and 2 groups with regular twice-daily treatment using either beclomethasone, 250 μg, (n = 110) or combination therapy (n = 113), plus as-needed albuterol, 100 μg. Combination therapy consisted of beclomethasone, 250 μg, and albuterol, 100 μg, in a single inhaler. Outcomes: Mean morning peak expiratory flow (PEF) during weeks 23 and 24. Secondary outcomes included asthma exacerbations, lung function measures, asthma scores, and percentage of days without asthma symptoms or use of albuterol. Equivalence between groups was defined as < 10% (40 L/min) difference on the primary PEF outcome. Patient follow-up: 84% (modified intentionto-treat analysis included 455 patients [mean age 39 y, 59% women]).

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