Montelukast–Acebrophylline Combination: Favorable Safety and Clinical Benefits in Asthma, finds study
A new study published in The Journal of Asthma showed that the fixed-dose combination (FDC) of montelukast and acebrophylline showed a good safety profile and was linked to improvements in lung function and asthma symptoms, which indicates that it may be a well-tolerated treatment option for managing asthma.
Due in large part to poor inhaler technique and inadequate adherence to inhaled corticosteroids, asthma management is still poor worldwide despite the availability of therapies. This research assesses the safety and therapeutic effectiveness of a once-daily oral fixed dosage combination of montelukast and acebrophylline for enhancing patients' asthma control in order to get over these obstacles.
Adult patients with moderate to severe asthma participated in this clinical research. Patients who satisfied the GINA guidelines' qualifying requirements were included. Before starting the 12-week therapy, they had a washout. Screening and enrollment visits were part of the study, as were follow-ups on days 28, 56, and 84.
The primary objective was the number of adverse events (AEs), with secondary outcomes included changes in trough forced expiratory volume in one second (FEV1), forced vital capacity (FVC), Asthma Symptom Utility Index (ASUI) scores, and usage of rescue medicine.
There were 211 asthmatic patients in all. The average age and body mass index (BMI) were 39.52 ± 11.68 years and 23.83 ± 4.37 kg/m2, respectively.
10.9% of patients had adverse events (AEs), the majority of which were minor in severity.
Treatment discontinuation was the outcome of one severe adverse event that was unrelated to the therapy.
With mean improvements 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), lung function significantly improved.
By Day 84, fewer patients needed rescue medicine as its use gradually declined.
Overall, the results show that the FDC of acebrophylline SR 200 mg and montelukast 10 mg has a good safety profile and is linked to improvements in lung function and asthma symptoms in Indian patients.
Over the course of the 12-week treatment period, the therapy led to statistically significant improvements in lung function measures (FEV1 and FVC), ASUI scores, and a decrease in the need of rescue medications.
Source:
Ludam, R., Agrawal, M., Patel, K. M., Singh, A., Kumar, P. S., Murthy, M. G. K., Parmar, K., Mishra, V. D., Rao, S. N., Pandharkar, V., Kumari, S. L., Shetty, A., Saha, S., Patil, D., Ghadge, P., & Mehta, S. (2026). Clinical outcomes with a fixed-dose combination of oral montelukast and acebrophylline in bronchial asthma: a prospective, single-arm clinical study. The Journal of Asthma: Official Journal of the Association for the Care of Asthma, 1–11. https://doi.org/10.1080/02770903.2026.2706358
