Clinical Trial of Efficacy and Safety of Levopront® 30 mg/5 ml in Patients With Dry Cough (NCT03837938) | Clinical Trial Compass
CompletedPhase 3
Clinical Trial of Efficacy and Safety of Levopront® 30 mg/5 ml in Patients With Dry Cough
Russia184 participantsStarted 2016-11-09
Plain-language 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
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
âś“. Signed Informed Consent Form
âś“. Male or female aged from 18 to 65 (inclusive)
âś“. Dry non-productive cough as a symptom of acute upper respiratory infection (IDC codes J00-J06)
✓. Daytime cough symptom score ≥ 3 points according to the "Six-point daytime and nighttime cough assessment scale"
✓. Pre-bronchodilator FEV1 ≥ 70% of the predicted values, post-bronchodilator FEV1 increase of ≤ 12% or ≤ 200 ml compared to the baseline, FEV1/FVC (Tiffeneau index) ≥ 0.7
âś“. Patient's consent to follow the protocol procedures, including the completion of the patient's diary
âś“. Patient's consent to use the adequate contraception methods throughout the study period. The adequate birth control methods are as follows:
Exclusion criteria
âś•. Hypersensitivity or individual contraindications to Levodropropizine, Prenoxdiazine or additives of the study drug
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What they're measuring
1
Number of Participants With Daytime Cough Resolution Rate by Day 8 in the PP Population
Timeframe: At Visit 3, Day 8
2
Number of Participants With Daytime Cough Resolution Rate by Day 8 in the ITT Population
âś•. Tuberculosis, bronchial asthma, malignant tumors of lungs or bronchi, COPD, severe respiratory failure (cyanosis, need for respiratory support) or other lung pathology at screening or in history
âś•. Inhalation anesthesia within 3 months before screening
âś•. Smoking history of more than 10 pack-years
âś•. Previous use of cough medicines, ACE inhibitors or amiodarone within 30 days before screening
âś•. Contraindications or inability to perform spirometry
âś•. Necessity (in the Investigator's opinion) of prescribing mucolytic agents, expectorants, antibiotics or other medications prohibited by the protocol during the study