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.