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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
184
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).
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.
State Public Healthcare Institution of Moscow "City Clinical Hospital # 71 of Moscow Healthcare Department"
Moscow, Russia
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, Russia
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, Russia
"Institute of Medical Research" LLC
Saint Petersburg, Russia
Saint-Petersburg State Healthcare Institution "Nikolaevskaya Hospital"
Saint Petersburg, Russia
State Healthcare Institution "Regional Clinical Hospital"
Saratov, Russia
LLC Treatment-and-prophylactic institution on the "Smolensk clinic"
Smolensk, Russia
State Autonomous Healthcare Institution of Yaroslavl Region "Clinical Hospital of Emergency care n.a. N.V. Solovyev"
Yaroslavl, Russia
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.
Time frame: 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.
Time frame: At Visit 3, Day 8
Number of Participants With Nighttime Cough Resolution Rate by Day 8 in the ITT Population
Night-time cough ( \>22:00 h up to 08:00 h) was evaluated on a 6-point scale (Six-point daytime and nighttime cough assessment scale") where 0 = no cough during the night to 5 = distressing coughs preventing any sleep. The nighttime 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.
Time frame: At Visit 3, Day 8
Number of Participants With Daytime & Nighttime Cough Symptoms Resolution 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 to 5 = distressing coughs most of the day. Night-time cough ( \>22:00 h up to 08:00 h) was evaluated on a 6-point scale (Six-point daytime and nighttime cough assessment scale) where 0 = no cough during the night to 5 = distressing coughs preventing any sleep. The (daytime and nighttime) 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 4 in the study treatment group and in the control group with a non-inferiority margin of δ = 20% is reported.
Time frame: 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
Daytime cough ( \>08:00 h up to 22:00 h) evaluated on a 6-point scale: 0 = no cough during the day to 5 = distressing coughs most of the day. Night-time cough ( \>22:00 h up to 08:00 h) evaluated on a 6-point scale: 0 = no cough during the night to 5 = distressing coughs preventing any sleep.
Time frame: 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.
The visual-analogue scale (VAS) is a 100 mm scale which ranges from 'no cough' (0 mm) to 'the worst cough severity' (100 mm). The higher the score, the worse the outcome.
Time frame: 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.
FEV1 is the Forced Expiratory Volume (in liters) in 1 second. The higher the value, the better the outcome.
Time frame: At Visit 3 (Day 8)
Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) of the Various Severity According to Subjective Complaints
Adverse Event (AE) - any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, complaint or disorder. Serious Adverse Event (SAE) - Any adverse medical event which, irrespective of the dose of the study drug: * results in death; * is life-threatening; * requires hospitalization (initial or prolonged); * results in significant, persistent or permanent impairment or disability; or * is a congenital anomaly or birth defect * is an important medical event that may be not immediately life threatening or result in death or hospitalization but, based upon appropriate medical judgment, may jeopardize the patient and may require medical or surgical intervention to prevent one of the outcomes listed in the definition above.
Time frame: From the moment of signing Informed Consent Form (prior to administration of the first dose of the study drug) to Day 30 after the last visit of the patient or last procedure per protocol, up to day 10"
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