Acute exacerbations of chronic bronchitis (AECB) are recurrent attacks due to worsening bronchial inflammation. These are marked by an increase in the volume of daily sputum which is produced along with a change in color of the expectorated sputum and dyspnea gets worsened. Farcosolvin is a mixture of ambroxol (15 mg), guaiphenesin (30 mg) and theophylline (50 mg) per 5 mL of syrup.

The main objective is to evaluate the clinical efficacy of ambroxol-theophylline-guaiphenesin mixture in the treatment of AECB in a single-blinded, randomized and controlled trial. One hundred patients with AECB were randomized to ambroxol-theophylline-guaiphenesin mixture or guaiphenesin treatment groups accordingly with the standard medical treatment for their cases. Baseline clinical symptomatology such as breathlessness, cough and severity scoring of sputum were compared before and after 3 and 7 days of treatment in both groups. Changes in improvement were compared in both the groups by the Clinical Global Impression of Change Scale (CGIC).

The results of the trial stated that significant improvements in breathlessness and cough scores in both groups was observed in pre-treatment versus post-treatment at day 3 and at day 7. Significant differences between groups were also observed in improvement related to breathlessness and cough scores, after 3- and 7-days treatment, favouring the ambroxol-theophylline-guaiphenesin mixture treatment group (P < 0.001).

48 patients out of 5o patients (i.e., 96%) in the ambroxol-theophylline-guaiphenesin treated group evaluated their improvement on the CGIC scale as "much" and "very much" improved. Only 41 patients (i.e., 82%) reported a degree of improvement in the control group.

The study concluded that ambroxol-theophylline-guaiphenesin syrup could be safe and effective in improving symptoms in acute exacerbation of chronic bronchitis cases.

Yakoot M, Salem A, Omar AM. Clinical efficacy of farcosolvin syrup (ambroxol-theophylline-guaiphenesin mixture) in the treatment of acute exacerbation of chronic bronchitis. Int J Chron Obstruct Pulmon Dis. 2010 Aug 9;5:251-6. doi: 10.2147/copd.s10981. PMID: 20714379; PMCID: PMC2921693.