Clinical Trial of Efficacy and Safety of Levopront® 30 mg/5 ml in Patients With Dry Cough

Summary

Primary objective: To assess the efficacy of Levopront® in comparison with Libexin® based on daytime cough resolution rate by Day 8. The daytime cough symptoms resolution corresponds to 0 or 1 points on the "Six-point daytime and nighttime cough assessment scale". Secondary objectives: Treatment effect assessment in terms of the following efficacy and safety parameters: * To assess the efficacy of Levopront® in comparison with Libexin® based on nighttime cough resolution rate by Day 8. * Daytime and nighttime cough symptoms resolution according to "Six-point daytime and nighttime cough assessment scale" by Day 4. * Change in severity and frequency of daytime and nighttime cough according to "Six-point daytime and nighttime cough assessment scale" on Day 4 and Day 8 from baseline on Day 1. * Cough intensity change according to the visual-analogue scale on Day 4 and Day 8 from baseline on Day 1. * Change of FEV1 on Day 8 from baseline values on Day 1. * Rate of Adverse events (AE) and Serious Adverse Events (SAE) of the various severity according to subjective complaints, laboratory test results, physical examination, vital signs and spirometry

Timeline

Start

2016-11-09

Primary completion

2018-03-06

Completion

2018-07-31

Drugs

Indications

No indication recorded.