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

2019-02-17 22:19:15 | BioPortfolio


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


This is a multicenter, open-label, randomized, clinical trial to assess the efficacy and safety of Levopront® syrup 30 mg/5 ml in comparison with Libexin® 100 mg tablets in patients suffering from dry non-productive cough caused by acute upper respiratory infection

Study Design




Levopront® syrup 30 mg/5 ml, Libexin®


State Public Healthcare Institution of Moscow "City Clinical Hospital # 71 of Moscow Healthcare Department"
Russian Federation




Dompé Farmaceutici S.p.A

Results (where available)

View Results


Published on BioPortfolio: 2019-02-17T22:19:15-0500

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