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

NCT03837938 | Completed Phase 3 Results

• 1 other identifier: LDP0114
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 8

Brief 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

Conditions

Cough

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Daytime Cough Resolution Rate by Day 8 in the PP Population

  Daytime cough (\>08:00h up to 22:00 h) was evaluated on a 6-point scale (Six-point daytime and nighttime cough assessment scale") where 0 = no cough during the day; and 5 = distressing cough most of the day. The daytime cough symptoms resolution corresponds to 0 or 1 points on the 6-point scale. The lower the score the better the outcome. The rate of patients who responded to treatment (cough absents, when score is 0 or 1 at "six-point cough scale" vs. cough presents, when score is ≥ 2 at "six-point cough score") by Day 8 in the study treatment group and in the control group with a non-inferiority margin of δ = 20% is reported.

  At Visit 3, Day 8

• Number of Participants With Daytime Cough Resolution Rate by Day 8 in the ITT Population

  Daytime cough (\>08:00h up to 22:00 h) was evaluated on a 6-point scale (Six-point daytime and nighttime cough assessment scale") where 0 = no cough during the day; and 5 = distressing cough most of the day. The daytime cough symptoms resolution corresponds to 0 or 1 points on the 6-point scale. The lower the score the better the outcome. The rate of patients who responded to treatment (cough absents, when score is 0 or 1 at "six-point cough scale" vs. cough presents, when score is ≥ 2 at "six-point cough score") by Day 8 in the study treatment group and in the control group with a non-inferiority margin of δ = 20% is reported.

  At Visit 3, Day 8

Secondary Outcomes (6)

• Number of Participants With Nighttime Cough Resolution Rate by Day 8 in the ITT Population

  At Visit 3, Day 8

• Number of Participants With Daytime & Nighttime Cough Symptoms Resolution in the ITT Population

  At Visit 2, Day 4

• Change From Baseline in Severity and Frequency of Daytime and Nighttime Cough According to "Six-point Daytime and Nighttime Cough Assessment Scale" in the ITT Population

  Baseline, At visit 2 Day 4; at visit 3, Day 8

• Change From Baseline in Cough Intensity According to the Visual-analogue Scale (VAS) in the ITT Population.

  Baseline, At visit 2 (Day 4); at visit 3 (Day 8)

• Change From Baseline in Pre-bronchodilator FEV1 Values on Day 8 in the ITT Population.

  At Visit 3 (Day 8)

Study Arms (2)

Levopront® syrup 30 mg/5 ml

EXPERIMENTAL

Levopront® (levodropropizine) syrup 30 mg/5 ml 10 ml (60 mg) t.i.d. for 7 days. The study drugs was taken 3 times a day, at intervals of at least 6 hours, between meals for 7 days.

Drug: Levopront® syrup 30 mg/5 ml

Libexin® 100 mg tablets

ACTIVE COMPARATOR

Libexin® (prenoxdiazine) 100 mg tablets. Libexin® was administered orally, 1 tablet (100 mg) 3 times a day for 7 days.

Drug: Libexin®

Interventions

Levopront® syrup 30 mg/5 ml DRUG

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).

Also known as: levodropropizine

Levopront® syrup 30 mg/5 ml

Libexin® DRUG

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.

Also known as: prenoxdiazine

Libexin® 100 mg tablets

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed Informed Consent Form
• Male or female aged from 18 to 65 (inclusive)
• 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
• Patient's consent to follow the protocol procedures, including the completion of the patient's diary
• Patient's consent to use the adequate contraception methods throughout the study period. The adequate birth control methods are as follows:
• Oral or transdermal contraceptives
• Condoms or diaphragms (barrier method) with spermicide
• Intrauterine contraceptive devices

You may not qualify if:

• Subjects with any of the following conditions will be excluded from the study:
• Hypersensitivity or individual contraindications to Levodropropizine, Prenoxdiazine or additives of the study drug
• Hereditary fructose intolerance, glucose-lactose malabsorption, lactase deficiency, sucrose-isomaltose deficiency
• 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
• Inhalation anesthesia within 3 months before screening
• Smoking history of more than 10 pack-years
• Previous use of cough medicines, ACE inhibitors or amiodarone within 30 days before screening
• Contraindications or inability to perform spirometry
• Necessity (in the Investigator's opinion) of prescribing mucolytic agents, expectorants, antibiotics or other medications prohibited by the protocol during the study
• Excessive mucous excretion which (in the Investigator's opinion) could be a contraindication to prescribing anti-cough medicines; decreased mucociliary function (Kartagener's syndrome, ciliary dyskinesia)
• Malignant tumors in the past 5 years (except for the basal cell carcinoma)
• Serious cardiovascular disease at the moment or within 12 months prior to screening, including: Chronic heart failure class III or IV (according to the classification of the New York Heart Association), severe arrhythmias requiring treatment with antiarrhythmic drugs class Ia, Ib, Ic or III, unstable angina, myocardial infarction, heart surgery and coronary arteries, serious valvular heart disease, transient ischemic attack or stroke, uncontrolled hypertension with systolic blood pressure \> 180 mmHg and diastolic blood pressure \> 110 mmHg, pulmonary embolism or deep vein thrombosis
• Gastric or duodenal ulcers, gastroesophageal reflux disease within a period of 12 months before screening
• Systemic autoimmune disorders and connective tissue diseases that require (currently or previously) administration of systemic glucocorticosteroids, cytostatic medications or penicillamine
• Signs of intensive non-controlled concurrent disease, including disorders of the nervous system, endocrine system, kidneys, liver or gastrointestinal tract, which (in the Investigator's opinion) could prevent the patient's participation in the study

Sponsors & Collaborators

• Dompé Farmaceutici S.p.A: lead

Study Sites (8)

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

Moscow, 121374, Russia

Location

The Laboratory of Pulmonology, State Budgetary Educational Institution of Higher Professional Education "Moscow State Medical-Stomatological University n.a. A.I. Evdokimov" under Ministry of Health of the Russian Federation (Clinical base of state budget

Moscow, 127473, Russia

Location

State Budgetary Educational Institution of Higher Professional Education "Ryazan' State Medical University n.a. academician I.P. Pavlov" under Ministry of Health of the Russian Federation

Ryazan, 390026, Russia

Location

"Institute of Medical Research" LLC

Saint Petersburg, 196084, Russia

Location

Saint-Petersburg State Healthcare Institution "Nikolaevskaya Hospital"

Saint Petersburg, 198510, Russia

Location

State Healthcare Institution "Regional Clinical Hospital"

Saratov, 410053, Russia

Location

LLC Treatment-and-prophylactic institution on the "Smolensk clinic"

Smolensk, 214016, Russia

Location

State Autonomous Healthcare Institution of Yaroslavl Region "Clinical Hospital of Emergency care n.a. N.V. Solovyev"

Yaroslavl, 150003, Russia

Location

MeSH Terms

Conditions

Cough

Interventions

dipropizine; libexin

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Mauro P Ferrari, Pharm D
• Organization: Dompé Farmaceutici SpA

clinical.trials@dompe.com

+39 02 583831

Study Officials

• Federico Saibene, MD

  Dompé SpA Milan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: It is an open-label clinical trial
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2019
• First Posted: February 12, 2019
• Study Start: November 9, 2016
• Primary Completion: March 6, 2018
• Study Completion: July 31, 2018
• Last Updated: April 16, 2024
• Results First Posted: April 15, 2024

Record last verified: 2023-10

Locations

RU (8)