Clinical Trial of Efficacy and Safety of Levopront® 30 mg/5 ml in Patients With Dry Cough
Status:
Completed
Trial end date:
2018-07-31
Target enrollment:
Participant gender:
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