Introduction: Productive cough leads to expectoration of sputum for more than 8 weeks and is a common symptom that affects a large portion of the general population. A phase IV clinical study was conducted to determine the efficacy and safety of an FDC containing Terbutaline, Ambroxol and Guaiphenesin for the treatment of productive cough on Indian patients.
Methodology: Out of 450 patients, 437 patients completed the study. Efficacy assessment was evaluated by reduction of Cough severity score (CSS) in relation to cough intensity, frequency and ease of cough and extrapolating to four point Likert-type scale. Safety assessment was made by scrutinising the adverse events during the clinical trial.
Results: Reduction in mean CSS was from 6.81 (baseline) to 3.56 (day 3) to 0.90 (day 5). One point reduction in Likert-type symptom scale from Severe to Moderate took just 3 days. Majority of patients had more than 80% reduction in their mean CSS score at conclusion visit (day 5) in all the parameters. Overall 2.97% of patient’s observed mild intensity adverse events which include palpitation, stomach upset/acidity and nausea/vomiting.
Conclusion: The combination of Terbutaline, Ambroxol and Guaiphenesinis efficacious and safe for the treatment of productive cough.
