Real-World Effectiveness of Budesonide Monotherapy via Pressurized Metered-Dose Inhaler in Steroid-Naive Pediatric Asthma.

BACKGROUND

Inhaled corticosteroids (ICS) remain the cornerstone of asthma management in children. However, real-world evidence evaluating the effectiveness of budesonide monotherapy in steroid-naive pediatric patients is limited. This study aimed to assess the impact of inhaled budesonide delivered via a pressurized metered-dose inhaler (pMDI) on pulmonary function and asthma control in steroid-naive children with bronchial asthma.

METHODS

This prospective observational study was conducted in the Asthma Clinic, Department of Pediatrics, King George's Medical University, Lucknow, from April 2022 to March 2023 after ethical approval. A total of 108 children aged 5-12 years with physician-diagnosed asthma were screened. After applying inclusion and exclusion criteria, 50 steroid-naive children were enrolled. Steroid-naive status was defined as no prior regular ICS use and no systemic corticosteroid exposure within the preceding three months. All participants received inhaled budesonide monotherapy at a low- to medium-dose of 200-400 μg/day, as per Global Initiative for Asthma (GINA) recommendations, via pMDI with spacer. Baseline and three-month assessments included spirometry (forced expiratory volume in one second (FEV₁), FEV₁% predicted, forced expiratory flow between 25% and 75% (FEF25-75% predicted)), Childhood Asthma Control Test (CACT), Mini Pediatric Asthma Quality of Life Questionnaire (MiniPAQLQ), and Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ). Paired comparisons were performed, and p<0.05 was considered statistically significant.

RESULTS

Significant improvement was observed in pulmonary function parameters after three months of budesonide therapy. Post-bronchodilator FEV₁ increased significantly (p<0.001), and FEV₁% predicted improved by 28.7% (p<0.001). FEF25-75% predicted showed a 17.1% increase, indicating improvement in small airway function. Asthma control improved substantially, with 56% of children achieving controlled asthma status at three months compared to none at baseline (p<0.001). Mean CACT scores increased significantly, accompanied by clinically meaningful improvements in MiniPAQLQ and PACQLQ scores (p<0.001 for all comparisons). Budesonide was well tolerated, with no serious adverse effects reported.

CONCLUSION

Inhaled budesonide monotherapy administered via pMDI significantly improves pulmonary function, asthma control, and quality of life in steroid-naive pediatric asthma patients within three months. These findings suggest that budesonide alone is an effective and reliable controller therapy in real-world clinical settings.