Year: 2026 | Month: July-September | Volume: 11 | Issue: 3 | Pages: 274-285
DOI: https://doi.org/10.52403/ijshr.20260331
Comparative Study to Evaluate the Effect of Tiotropium and Formoterol versus Glycopyrronium and Formoterol Combination on Pulmonary Functions in Patients with Chronic Obstructive Pulmonary Disease
Shalini1, Atul Jain2, Arpita Singh3, Abhishek Verma4
1Assistant Professor, Department of Pharmacology, A.S.J.S.A.T.D.S Medical College (ASMC), Fatehpur
2Professor, Department of Pharmacology, Dr. RMLIMS, Lucknow
3Professor & HOD, Department of Pharmacology, Dr. RMLIMS, Lucknow
4Assistant Professor, Department of Respiratory Medicine, Dr. RMLIMS, Lucknow
Corresponding Author: Dr. Shalini
ABSTRACT
Background: Chronic Obstructive Pulmonary Disease (COPD) is characterized by persistent airflow limitation with symptoms such as dyspnea, sputum production and cough reported by patients. It is the 4th leading cause of death worldwide and 2nd in India. Bronchodilator agents, Long-Acting β-2 Agonists (LABA) and Long-Acting Muscarinic Antagonists (LAMA) are the cornerstone of all stages of COPD treatment. Long-acting bronchodilator therapy is known to improve lung function and quality of life in patients with COPD.
Aim: To Evaluate the effect of Tiotropium and Formoterol Vs Glycopyrronium and Formoterol Combination on Pulmonary Functions in Patients with Chronic Obstructive Pulmonary Disease
Objectives: The primary objective is to compare the pulmonary function parameters (FEV1 and FEV1/FVC) in COPD patients treated with TFF (Tiotropium and Formoterol) versus GFF (Glycopyrronium and Formoterol). The secondary objective is to compare the quality of life in COPD patients treated with TFF versus GFF.
Methodology: This comparative, two-group, single-centre observational longitudinal study included patients with COPD who were already receiving either Tiotropium and Formoterol (TFF) or Glycopyrronium and Formoterol (GFF) treatment for more than 3 months before enrolment. Patients were classified into the TFF or GFF group according to the treatment combination they were already receiving; no investigator-directed random allocation was performed. A total of 280 eligible patients were enrolled at baseline, with 140 patients in each group. Follow-up assessments were performed at baseline, 3 months and 6 months. Pulmonary function parameters (FEV1 and FEV1/FVC) and health-related quality of life (SGRQ; St. George’s Respiratory Questionnaire score) were assessed.
Results: Follow-up data were available for 262 patients at 3 months (130 in the TFF group and 132 in the GFF group) and 252 patients at 6 months (126 in each group). FEV1, FEV1/FVC and SGRQ scores improved over time in both treatment groups. Longitudinal analysis demonstrated a significant effect of time for FEV1, FEV1/FVC and SGRQ (p<0.001 for each) and a significant group × time interaction for FEV1 (p<0.001), FEV1/FVC (p<0.001) and SGRQ (p=0.005), indicating that the pattern of change over time differed between the treatment groups.
Conclusion: Both Tiotropium/Formoterol and Glycopyrronium/Formoterol were associated with significant improvement in pulmonary function and health-related quality of life over the 6-month follow-up period. The longitudinal analysis indicated differences in the pattern of response between the two treatment groups. As this was an observational study, these findings do not establish equivalence or non-inferiority between the two treatment combinations.
Keywords: Chronic Obstructive Pulmonary Disease, Tiotropium, Glycopyrronium, Formoterol Fumarate, Forced Expiratory Volume in 1 second, Forced Vital Capacity, St. George’s Respiratory Questionnaire