Objective: To assess quality of life changes in pediatric asthmatic patients switched into a single inhaler device of Budesonide/Formoterol.
Methods: Thirty pediatric patients (ages 6-15 years) with moderate to severe chronic asthma previously treated with inhaled beclometasone dipropionate at a daily dose of 400 g were selected to participate in an open label study. At the baseline- phase (one month), pulmonary function tests (PFTs), indicators of asthma control, and a quality of life assessment (using a special questionnaire) were evaluated. Patients were initiated on a single inhaler device containing budesonide 160 g/formoterol 4.5 microg, one inhalation twice daily instead of their previous inhaled corticosteroid and followed for two months. PFTs, indicators of asthma control, and a quality of life assessment were evaluated at each visit.
Results: After switching to the new therapy, patients showed significant changes towards better quality of life in all aspects. The overall score dropped from 1.75+/- 0.04 to 0.80 +/- 0.07 (mean +/- SEM), p< 0.001 (Score scale varies between 0: excellent to 2: very bad Health related quality of life). There was an improvement in the PFTs, where the FEV1% improved from 62.7+/- 2.8 to 87.4 +/- 4.6 (mean +/- SEM), and the FVC% improved from 83.2 +/- 3.5 to 101.9 +/- 5.3 (mean +/-SEM), p < 0.001, and better control of asthma.
Conclusion: Switching treatment from beclomethasone dipropionate to budesonide/formoterol combination appeared to improve quality of life in the patient population evaluated and in the appropriate clinical indices.