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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".
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
Levopront® syrup 30 mg/5 ml, Libexin®
State Public Healthcare Institution of Moscow "City Clinical Hospital # 71 of Moscow Healthcare Department"
Dompé Farmaceutici S.p.A
Published on BioPortfolio: 2019-02-17T22:19:15-0500
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