NCT03837938

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

Multicenter Open-label Randomized Clinical Trial of the Efficacy and Safety of Levopront® Syrup 30 mg/5 ml in Comparison With Libexin® 100 mg Tablets in Patients With Dry Non-productive Cough Caused by Acute Upper Respiratory Infection

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 184 (actual)
• Sponsor: Dompé Farmaceutici S.p.A · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Detailed description

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

Conditions

• Cough

Interventions

Type	Name	Description
DRUG	Levopront® syrup 30 mg/5 ml	The first study drug administration was performed at the clinical site on the day of randomization; the last study drug administration was performed in the evening before Day 8 (±1).
DRUG	Libexin®	The first study drug administration was performed at the clinical site on the day of randomization; the last study drug administration was performed in the evening before Day 8 (±1). No chewing.

Timeline

• Start date: 2016-11-09
• Primary completion: 2018-03-06
• Completion: 2018-07-31
• First posted: 2019-02-12
• Last updated: 2024-04-16
• Results posted: 2024-04-15

Locations

8 sites across 1 country: Russia