A clinical study of 211 adults in India found that a once-daily combination of montelukast 10 mg and acebrophylline 200 mg significantly improved lung function, reduced asthma symptoms, and decreased the need for rescue medications over 12 weeks, with a favorable safety profile and high treatment adherence rate of 97.2%.
- Study participants experienced average lung function improvements of 0.61 liters in FEV1 and 0.51 liters in FVC by day 84.
- Treatment adherence reached 97.2%, attributed to the convenience of a once-daily oral tablet format.
- Rescue medication use declined progressively throughout treatment, indicating improved asthma control.
A multicenter clinical study conducted across India has found that a once-daily, fixed-dose combination of montelukast and acebrophylline was associated with significant improvements in lung function and asthma symptoms as well as reduced reliance on rescue medication among adults with moderate to severe asthma.
Findings were detailed in the paper, “Clinical Outcomes With a Fixed-Dose Combination of Oral Montelukast and Acebrophylline in Bronchial Asthma: A Prospective, Single-Arm Clinical Study,” published in the Journal of Asthma.
The phase 4, prospective clinical trial enrolled 211 adults with asthma at 13 centers across India. Participants received a once-daily oral tablet containing montelukast 10 mg and sustained-release acebrophylline 200 mg for 12 weeks. Researchers primarily evaluated safety while also measuring changes in lung function, symptom scores and rescue medication use. Results demonstrated a favorable safety profile over the 12-week period.
According to the study, adverse events were reported in only 10.9% of participants, with most classified as mild. One serious adverse event, a lower respiratory tract infection requiring hospitalization, occurred during the trial but was determined to be unrelated to the medication. All reported adverse events had resolved by the end of the study, the authors noted.
Researchers reported substantial improvements in key measures of lung function. By day 84, patients experienced an average increase of 0.61 liters in forced expiratory volume in one second (FEV1) and 0.51 liters in forced vital capacity (FVC), both statistically significant improvements from baseline. Asthma Symptom Utility Index (ASUI) scores also improved significantly throughout the study period.
Further evidence demonstrated that the need for rescue medication declined progressively during treatment, suggesting improved asthma control among study participants. Researchers reported that treatment adherence was notably high, reaching 97.2%, which they said may reflect the convenience of a once-daily oral regimen.
Poor adherence to inhaled corticosteroids, the cornerstone of guideline-recommended asthma management, continues to contribute to poor disease control in many regions, the authors wrote. Additionally, cultural barriers, inhaler technique difficulties and concerns about long-term medication use have all been identified as challenges to adherence, particularly in parts of Asia, they noted.
The study’s authors suggested that an oral fixed-dose combination may offer a practical treatment option for patients who struggle with inhaler use or who do not consistently adhere to inhaled therapies. However, they emphasized that current international asthma guidelines continue to recommend inhaled corticosteroid-based treatment as the standard of care.
Researchers cautioned that the study was a single-arm, open-label trial with no comparison group. As a result, the improvements observed cannot be definitively attributed to the medication alone, they said, and further controlled studies are needed to determine how the combination performs compared with standard inhaled therapies.
