Comparative Efficacy of Formoterol Combined Section with Glycopyrronium versus Budesonide in Managing Chronic Obstructive Pulmonary Disease: A Randomised Clinical Trial

Introduction: Chronic Obstructive Pulmonary Disease (COPD) is a leading global health issue, often resulting from prolonged exposure to harmful particles or gases. The 2022 Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines suggest using combinations of Long-acting Beta Agonist plus Inhaled Corticosteroid (LABA+ICS), Long-acting Beta Agonist plus Long-Acting Muscarinic Antagonist (LABA+LAMA) or LAMA for treatment, but do not specify which combination is most effective. Studies have shown mixed results regarding the superiority of LABA+ICS over LABA+LAMA, with some suggesting better outcomes for LABA+ICS, while others report similar or even better efficacy for LABA+LAMA. Aim: To compare the effects of Formoterol+Glycopyrronium (LABA+LAMA) versus Formoterol+Budesonide (LABA+ICS) in COPD patients by evaluating changes in spirometry, 6-minute walk test performance, side-effects and Quality Of Life (QOL). Materials and Methods: This double-blinded Randomised Clinical Trial (RCT) included 70 COPD patients visiting the Department of Respiratory Medicine at BLDE (Deemed to be University) Shri BM Patil Medical College, Hospital and Research Centre, Vijayapura, Karnataka, India. The study compared two treatment regimens: LABA+LAMA (Formoterol+Glycopyrronium) FM-GP group and LABA+ICS (Formoterol+Budesonide) FM-PD group. The study’s sample size was 70 patients, with 35 in each group. Inclusion criteria included patients aged over 40, of either sex and willing to provide informed consent. Several tools were used to assess the severity and prognosis of COPD, including spirometry, the Six-minute Walk Test (6MWT), the Body Mass Index, Airflow Obstruction, Dyspnoea and Exercise Capacity (BODE) index, the COPD Assessment Test (CAT), the Clinical COPD Questionnaire (CCQ) and the modified Medical Research Council (mMRC) scale. Follow-up assessments took place after three months. The data were analysed using Statistical Package for the Social Sciences (SPSS) version 20.0 and the results are presented as mean±SD, median, interquartile range and percentages. Results: The mean age was 64.41 years in the FM-BD group and 64.75 years in the FM-GP group, respectively. In a study of 70 COPD patients, both the Formoterol-Budesonide (FM-BD) and FormoterolGlycopyrronium (FM-GP) groups showed improvements in various parameters over three months. The FM-GP group exhibited a significant improvement in predicted Forced Expiratory Volume in One Second (FEV1) (p=0.001) and a more substantial reduction in the BODE index (p=0.04). Both groups showed significant improvements in mMRC scores, with the FM-GP group showing a slightly better outcome (p=0.019). The FM-BD group had more adverse effects and hospitalisations, including higher rates of exacerbations and Intensive Care Unit (ICU) admissions. Conclusion: The FM-GP group showed significant improvement in mMRC and BODE Index and reduced adverse effects and rates of exacerbations compared to the FM-BD group. The mean change in post-bronchodilator FEV1 was significant in the FM-BD group compared to the FM-GP group.