Effect of Theophylline as Adjunct to Inhaled Corticosteroids on Exacerbations in Patients With COPD: A Randomized Clinical Trial

Background: Chronic Obstructive Pulmonary Disease (COPD) is a progressive lung disease characterized by chronic inflammation and irreversible airflow obstruction, leading to frequent exacerbations that significantly impair quality of life.Standard treatments, including inhaled corticosteroids (ICS), show variable efficacy in preventing exacerbations, highlighting the need for adjunct therapies.Objective: This study aims to investigate the efficacy and safety of adding low-dose theophylline to ICS therapy in reducing the frequency and severity of exacerbations in COPD patients. Methods:A randomized, double-blind, placebo-controlled clinical trial was conducted from March 2024 to October 2024, involving 200 adults diagnosed with COPD.Participants were assigned to receive either ICS plus low-dose theophylline (200 mg twice daily) or ICS alone.The primary outcome was the frequency of exacerbations requiring antibiotics or corticosteroids over 6 months, with secondary outcomes including lung function, quality of life, and adverse events. Results:The addition of low-dose theophylline significantly reduced the mean number of exacerbations (2.27 vs. 2.76, P < 0.0001) and hospital admissions (0.15 vs. 0.27, P < 0.0001) compared to ICS alone.Improvements in FEV1 % predicted and COPD Assessment Test (CAT) scores were also observed, with significant differences noted at 6 months.Safety analysis indicated a higher incidence of non-serious and serious adverse drug reactions in the combination group, but pneumonia cases and mortality rates were comparable between groups. Conclusion:The study concludes that low-dose theophylline as an adjunct to ICS therapy provides significant clinical benefits in managing COPD, including reduced exacerbations, improved lung function, and enhanced quality of life, with an acceptable safety profile.Further research is warranted to validate these findings and explore optimal dosing strategies.