On-demand intermittent beclomethasone is effective for mild asthma in Brazil

Abstract

Background: Daily inhaled corticosteroids are widely recommended for mild persistent asthma. This study aimed to assess the efficacy of the intermittent use of beclomethasone as an alternative treatment for mild persistent asthma. Methods: In this 16-week trial, children aged 6-18 years were evaluated. Subjects in the continuous treatment arm of the study received 500 μg/day of beclomethasone, whereas the intermittent ones were given 1000 μg/day (250 μg every 6 h) in combination with albuterol for 7 days upon exacerbations or worsening of symptoms. Primary outcome (i.e., treatment failure) was the occurrence of any asthma exacerbation requiring prednisone, and co-secondary outcomes were the mean/median differences for both, (1) the pre-bronchodilator FEV1 (% predicted) and (2) asthma control test (ACT/cACT) scores, from randomization to the last follow-up visit, and beclomethasone and albuterol consumption. Results: Ninety-four subjects from each treatment arm were included. They were comparable regarding all baseline characteristics; prednisone was used by 10 (10.6%) and 7 (7.4%) patients, respectively (95% CI - 6.1 to 12.6%, for the difference; p = 0.47). Statistical analysis showed no statistically significant differences with respect to both FEV1 (p = 0.39) and ACT/cACT scores (p = 0.38). As assessed through canister weighting, children used from 0.5 to 0.7 and from 1.6 to 1.8 puffs per day of beclomethasone in the intermittent and continuous regimens, respectively. Regarding albuterol, received 0.3-0.4 (intermittent) and 0.1-0.2 (continuous) inhalations per day. There were no relevant clinical or functional differences between the two treatment regimens. Conclusion: Clinicians might consider intermittent inhaled steroid therapy as a therapeutic regimen for mild persistent asthma. Trial registration The Portuguese and English versions of the study protocol were submitted, approved, and registered in the Brazilian Network Platform for Clinical Trials (http://www.ensaiosclinicos.gov.br) under the primary identifier number "RBR-3gbyhk". This platform is part of the Primary Registries in the World Health Organization Registry Network, where the trial is registered under the following Universal Trial Number: 1111-1149-4774