Clinical outcomes with a fixed-dose combination of oral Montelukast and Acebrophylline in bronchial asthma: a prospective, single-arm clinical study

Objective To evaluate the safety and clinical improvements with once daily fixed dose combination (FDC) of montelukast 10 mg and acebrophylline sustained-release 200 mg tablet in patients with asthma.Methods This multicenter, single-arm, open-label, prospective, phase IV clinical trial included adult patients with moderate to severe asthma. Patients meeting eligibility criteria based on GINA guidelines were included. They underwent a washout before initiating the 12-week treatment. Study visits included screening and enrollment visits, and follow-ups on days 28, 56, and 84.The primary outcome was the incidence of adverse events (AEs), while secondary outcomes included changes in trough forced expiratory volume in one second (FEV1), forced vital capacity (FVC), Asthma Symptom Utility Index (ASUI) scores, and rescue medication use.Results A total of 211 patients with asthma were included. The mean ± SD age and body mass index (BMI) were 39.52 ± 11.68 years and 23.83 ± 4.37 kg/m2, respectively. AEs were reported in 10.9% of patients, and most AEs were of mild severity. One serious AE, unrelated to treatment, resulted in treatment withdrawal. Lung function showed significant improvement, with mean changes from baseline to Day 84 of 0.61 ± 0.56 L in FEV1, 0.51 ± 0.65 L in FVC, and 0.17 ± 0.14 in ASUI scores (p < 0.0001 for all). Rescue medication use decreased progressively, with fewer patients requiring it by Day 84.Conclusion The findings demonstrate that the FDC of montelukast and acebrophylline has a favorable safety profile and is associated with improvements in lung function and asthma symptoms.Trial registration: CTRI/2020/02/023237 [Registered on: 11/02/2020] Trial Registered Prospectively, URL: https://ctri.nic.in/Clinicaltrials/pmaindet2.php?