Assessment of Adverse Drug Reactions and Health-Related Quality of Life Among COPD Patients Receiving Triple Inhaler Therapy: A Prospective Observational Study

Background:Chronic Obstructive Pulmonary Disease (COPD) is a leading cause of morbidity and mortality worldwide. Triple inhaler therapy comprising inhaled corticosteroids (ICS), long-acting β₂ agonists (LABA), and long-acting muscarinic antagonists (LAMA) is widely used in moderate to severe COPD. However, prolonged use may lead to adverse drug reactions (ADRs) that could influence treatment adherence and health-related quality of life (HRQOL).Objective:To evaluate the prevalence and pattern of ADRs and to assess their association with HRQOL among COPD patients receiving triple therapyMethods:A prospective observational study was conducted over six months in the respiratory medicine department of a tertiary care hospital. A total of 129 COPD patients aged ≥40 years receiving triple therapy (tiotropium, formoterol, budesonide) were included. ADRs were assessed using the Naranjo causality scale, and HRQOL was measured using the St George’s Respiratory Questionnaire (SGRQ). Statistical analysis was performed using SPSS with chi-square testing.Results:Among 129 participants, males constituted 58% and the majority were aged 60–69 years. ADRs were reported in a substantial proportion of patients, with dry mouth and oral candidiasis being the most frequent. Most ADRs were classified as probable or possible. HRQOL scores indicated moderate to severe impairment. There was no statistically significant association between ADR occurrence and HRQOL; however, age and comorbidities showed a significant relationship with poorer QOL outcomes.Conclusion:Triple therapy is associated with a notable incidence of ADRs, although these did not significantly affect HRQOL. Comorbidities and aging appear to be stronger determinants of reduced quality of life. Continuous monitoring and individualized management strategies are recommended to optimize outcomes.