Treatment of Nocturnal Asthma by Addition of Oral Slow-Release Albuterol to Standard Treatment in Stable Asthma Patients

Abstract

Nocturnal and early-morning complaints in asthma patients are sometimes difficult to treat. We investigated the efficacy of an oral osmotically controlled release (OR) formulation of albuterol 8 mg in 35 patients with stable asthma and nocturnal complaints and/or morning dipping of the peak expiratory flow (PEF). The mean age was 45 years (range 22-70), the FEV₁ was 61 ± 20% of predicted, and inhaled steroids were used by 32 patients. Albuterol OR was added to their usual treatment. The use of theophyllines and oral adrenergics was not allowed. Twice-daily (b.i.d.) dosing was compared to one dose at night and to placebo. The three-period crossover study was double-blind placebo-controlled with treatment periods of 2 weeks. Responses have been analyzed by means of multiple regression analysis at a significance level of 5%. There was no significant difference of the FEV₁ or the weekly means of PEFs between the periods. During the b.i.d. treatment, the daytime and nocturnal symptom scores, used rescue medication, subjective sleep quality, and nocturnal waking tended to be better. Mental fitness was improved, but significantly only in the morning. We concluded that additional treatment with albuterol 8 mg OR once or twice daily did not lead to an overall clinical improvement in this group of patients with nocturnal asthma during standard treatment. In view of the tendency to improvement, it may be worth trying this treatment in individual patients.