Inhaled budesonide for adults with mild-to-moderate asthma: a randomized placebo-controlled, double-blind clinical trial

Sao Paulo Medical Journal

Ana Luisa Godoy Fernandes²  Sonia Maria Faresin²  Maria Marta Amorim²  Carlos Cézar Fritscher¹  Carlos Alberto De Castro Pereira¹  José Roberto Jardim² 

[1] ,Universidade Federal de São Paulo Escola Paulista de Medicina Hospital São PauloSão Paulo,Brazil

关键词: Asthma;    Inhaled corticosteroid;    Budesonide;    Asma;    Corticóide inalatório;    Budesonida;   

DOI  :  10.1590/S1516-31802001000500004

来源: SciELO

【 摘 要 】

CONTEXT: Budesonide is an inhaled corticosteroid with high topical potency and low systemic activity recommended in the treatment of chronic asthma. OBJECTIVE: This study was conducted to determine the efficacy and safety of inhaled budesonide via a breath-activated, multi-dose, dry-powder inhaler. TYPE OF STUDY: Multicenter randomized parallel-group, placebo-controlled, double-blind, clinical trial. SETTING: Multicenter study in the university units. PARTICIPANTS: Adult patients with mild-to-moderate asthma that was not controlled using bronchodilator therapy alone. PROCEDURES: Comparison of budesonide 400 µg administered twice daily via a breath-activated, multi-dose, dry-powder inhaler with placebo, in 43 adult patients (aged 15 to 78 years) with mild-to-moderate asthma (FEV1 71% of predicted normal) that was not controlled using bronchodilator therapy alone. MAIN MEASUREMENTS: Efficacy was assessed by pulmonary function tests and asthma symptom control (as perceived by the patients) and the use of rescue medication. RESULTS: Budesonide 400 µg (bid) was significantly more effective than placebo in improving morning peak expiratory flow (mean difference: 67.9 l/min; P < 0.005) and FEV1 (mean difference: 0.60 l; P < 0.005) over the 8-week treatment period. Onset of action, assessed by morning peak expiratory flow, occurred within the first two weeks of treatment. CONCLUSIONS: Budesonide via a breath-activated, multi-dose, dry-powder inhaler results in a rapid onset of asthma control, which is maintained over time and is well tolerated in adults with mild-to-moderate asthma.

【 授权许可】

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