Clinical efficacy of farcosolvin syrup (ambroxol–theophylline–guaiphenesin mixture) in the treatment of acute exacerbation of chronic bronchitis

Mostafa Yakoot¹, Amel Salem², Abdel-Mohsen Omar^3
1Green Clinics and Research Center, Alexandria, Egypt; ²Al-Mabarah Hospital, ³Faculty of Pharmacy, Alexandria University, Alexandria, Egypt

Background: Acute exacerbations of chronic bronchitis (AECB) are defined as recurrent attacks of worsening bronchial inflammation that are marked by an increase in the volume of daily sputum produced, a change in color of the expectorated sputum, and worsening dyspnea. Farcosolvin^® (Pharco Pharmaceuticals, Alexandria, Egypt) is a mixture of ambroxol (15 mg); theophylline (50 mg); and guaiphenesin (30 mg), per 5 mL syrup.

Objective: To test the clinical efficacy of Farcosolvin in the treatment of AECB in a randomized, single-blinded, controlled study design.

Patients and methods: One hundred patients with AECB were randomized to either Farcosolvin or guaiphenesin treatment groups, in addition to the standard medical treatment for their cases. Baseline clinical symptomatolgy of breathlessness, cough, and sputum severity scoring were compared before and after 3 and 7 days of treatment in both groups and the differences compared between groups. Changes in perceived improvement were also compared between groups using the Clinical Global Impression of Improvement or Change Scale (CGIC).

Results: There were statistically significant improvements in breathlessness and cough scores in both groups (pretreatment versus posttreatment at day 3 and at day 7; P < 0.05). There were highly statistically significant differences between groups in improvement in ­breathlessness and cough scores, after 3 and 7 days treatment, in favor of the Farcosolvin ­treatment group (P < 0.001). Out of 50 patients, 48 (96%) in the Farcosolvin-treated group rated their ­improvement on the CGIC scale as “much” and “very much” improved, while only 41 patients (82%) reported such a degree of improvement in the control group. The difference was statistically significant (P < 0.05).

Conclusion: We concluded from our study that Farcosolvin syrup might be safe and effective in improving symptoms in cases of acute exacerbation of chronic bronchitis.

Keywords: acute exacerbation of chronic bronchitis, ambroxol, theophylline