ABSTRACT
In the treatment of asthma, the conventional measures used to monitor a patient's progress and health status do not address the impact of functional impairments associated with the disease that may affect the patient's daily life. Unlike those measures, health-related quality of life (HRQL) reflects the physical, psychological, and social difficulties a patient perceives on a day-to-day basis. This study was conducted to determine the effects of once-daily budesonide inhalation powder via the Pulmicort Turbuhaler on the HRQL in adult patients with asthma previously treated with other inhaled corticosteroids. A total of 184 patients 18 to 70 years of age who previously received inhaled corticosteroids were enrolled in this double-blind, placebo-controlled, parallel-group, multicenter study. Patients were randomly assigned to budesonide 400 microg once daily or to placebo for 12 weeks. Each patient's HRQL was assessed at randomization and at weeks 4 and 12 with the Asthma Quality of Life Questionnaire (AQLQ). More patients receiving budesonide than those receiving placebo reported statistically significant (P < or = .05) improvements in HRQL at weeks 4 and 12. With the exception of the domain pertaining to exposure to environmental stimuli, differences from placebo in overall AQLQ scores and individual domain scores were clinically important (> or = 0.5 units). In addition, 2.4 patients needed to be treated with once-daily budesonide for 1 patient to demonstrate clinically important improvement. Budesonide 400 microg administered once daily via the Pulmicort Turbuhaler provides statistically significant and clinically important HRQL benefit in adult patients with asthma previously receiving inhaled corticosteroids.
Subject(s)
Asthma/prevention & control , Bronchodilator Agents/therapeutic use , Budesonide/therapeutic use , Administration, Inhalation , Adolescent , Adult , Aged , Asthma/psychology , Bronchodilator Agents/administration & dosage , Bronchodilator Agents/chemistry , Budesonide/administration & dosage , Budesonide/chemistry , Chemistry, Pharmaceutical , Double-Blind Method , Drug Administration Schedule , Female , Humans , Male , Middle Aged , Quality of Life , Treatment Outcome , United StatesABSTRACT
This 12-week, double-blind, placebo-controlled, multicenter study evaluated the efficacy and safety of budesonide 400 microg administered once daily via Turbuhaler in adults previously treated with at least twice-daily dosing of inhaled corticosteroids. Pulmonary function (FEV1, PEF, FVC, FEF(25-75%)), asthma symptom scores, quality of life, and breakthrough medication use were significantly (p < 0.05) different in patients receiving once-daily budesonide Turbuhaler compared to placebo, and significantly (p < 0.001) more patients receiving placebo discontinued the study. Adverse events were similar between study groups. Once-daily administration of budesonide Turbuhaler was safe and efficacious in patients previously treated with inhaled corticosteroids.