A Randomized, Open-Label, Active-Controlled, Phase 3 Clinical Trial of FDC Erdosteine 300 mg and Acebrophylline 100 mg Tablet versus FDC Acebrophylline 100 mg and Acetylcysteine 600 mg Tablet in Treatment of Chronic Bronchitis in Participants with Chronic Obstructive Pulmonary Disease

Ashish Mungantiwar, Priyanka Shrivastava, Tejas Wattamwar

Abstract: Background: Chronic Obstructive Pulmonary Disease (COPD) and chronic bronchitis (CB) are progressive respiratory disorders characterized by mucus hypersecretion and airflow limitation. Thiol-based mucolytics such as erdosteine and N-acetylcysteine, along with bronchodilators like acebrophylline, have shown benefits in improving mucus clearance, reducing exacerbations, and enhancing respiratory function. Methods: This was a prospective, randomized, open-label, parallel-group, multi-center, active-controlled, phase 3 clinical trial with a 21-day treatment period. Eligible participants were randomized (1:1) to receive fixed dose combination (FDC) of erdosteine 300 mg + acebrophylline 100 mg (test drug) or FDC of acebrophylline 100 mg + acetylcysteine 600 mg (active-comparator). The study aimed to establish the superiority of the test drug in relieving CB symptoms in stable COPD participants. The primary endpoints were changes in total cough and sputum symptom scores from baseline to 21 days after the treatment. The secondary endpoint was the change in post-bronchodilator FEV? after 21 days of treatment. Safety assessments included monitoring adverse events, vital signs, and laboratory parameters. Results: Total of 204 participants completed the study (Test drug: 101; Active comparator: 103) out of 206 randomized participants. After 21 days of treatment, the FDC of erdosteine 300 mg and acebrophylline 100 mg demonstrated a higher reduction in total cough symptoms and sputum symptoms compared to FDC of acebrophylline 100 mg + acetylcysteine 600 mg. Improvements were observed across individual parameters of cough and sputum symptoms, including cough frequency, cough severity, chest discomfort, dyspnea, and expectoration difficulty, type of expectoration, and sputum viscosity in both the per-protocol (PP) and safety populations. The results confirmed the non-inferiority of the test drug compared with the active comparator in the improvement of post-bronchodilator FEV? after 21 days of treatment from baseline superiority of the test drug compared with the active comparator in improving cough and sputum symptoms. Conclusion: The FDC of erdosteine 300 mg + acebrophylline 100 mg is more beneficial in improvement of CB symptoms beyond normal day to day variation expanding the armamentarium of current treatment options and is superior to acebrophylline 100 mg and acetylcysteine 600 mg.

Keywords: COPD, Erdosteine, Acebrophylline, Cough symptom score, Sputum symptom score

How to Cite?: Ashish Mungantiwar, Priyanka Shrivastava, Tejas Wattamwar, "A Randomized, Open-Label, Active-Controlled, Phase 3 Clinical Trial of FDC Erdosteine 300 mg and Acebrophylline 100 mg Tablet versus FDC Acebrophylline 100 mg and Acetylcysteine 600 mg Tablet in Treatment of Chronic Bronchitis in Participants with Chronic Obstructive Pulmonary Disease", Volume 14 Issue 12, December 2025, International Journal of Science and Research (IJSR), Pages: 176-183, https://www.ijsr.net/getabstract.php?paperid=SR251202172147, DOI: https://dx.doi.org/10.21275/SR251202172147