[Control of asthma by treatment with inhaled corticosteroids and prolonged action beta 2-agonists in free or fixed combination. Results of the ALISE study]

Abstract

Context: The basics of asthma treatment are well defined in the guidelines, however the criteria for the choice between fixed and free combinations of inhaled corticosteroids and long acting beta 2-agonist have not been clearly established.

Method: A modified Juniper questionnaire (using peak expiratory flow rather than maximal expiratory volume per second) was used by 421 general practitioners to assess asthma control in 861 adult patients (aged 47 +/- 17 years) having received inhaled corticosteroids and long-acting beta 2-agonist in a fixed (n = 413) or free (n = 448) combination for at least 6 weeks.

Results: Treatment groups were comparable for demographics, asthma history and severity as assessed by the physician. Despite better compliance to treatment in the fixed combination group and a mean daily dose of corticosteroids around two-fold greater compared with free combination group (913 +/- 450 micrograms/d vs 401 +/- 178 micrograms/d), the mean Juniper score was lower in the free combination group (1.60 +/- 0.94 vs 1.73 +/- 0.96) with a greater percentage of patients controlled (Juniper score < 2): 67.6% vs 60.8%. Other treatments for asthma were significantly less frequent with the free combination (14.2% vs 22.3%), as were local side effects and notably voice changes (3.3% vs 9.5%.

Comments: The apparently greater efficacy/safety ratio of the free combination was probably due to the greater severity of asthma in the patients treated with a fixed combination. This highlights the interest of free combinations as first-line therapy for patient with mild to moderate asthma.