Cough
Conditions
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
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
Interventions
DRUGLevopront® 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).
DRUGLibexin®
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.
Sponsors
Dompé Farmaceutici S.p.A
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
It is an open-label clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Subjects should meet the following inclusion criteria to be included into this clinical trial: 1. Signed Informed Consent Form 2. Male or female aged from 18 to 65 (inclusive) 3. Dry non-productive cough as a symptom of acute upper respiratory infection (IDC codes J00-J06) 4. Daytime cough symptom score ≥ 3 points according to the Six-point daytime and nighttime cough assessment scale 5. 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 6. Patient's consent to follow the protocol procedures, including the completion of the patient's diary 7. 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
Exclusion criteria
Subjects with any of the following conditions will be excluded from the study: 1. Hypersensitivity or individual contraindications to Levodropropizine, Prenoxdiazine or additives of the study drug 2. Hereditary fructose intolerance, glucose-lactose malabsorption, lactase deficiency, sucrose-isomaltose deficiency 3. 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 4. Inhalation anesthesia within 3 months before screening 5. Smoking history of more than 10 pack-years 6. Previous use of cough medicines, ACE inhibitors or amiodarone within 30 days before screening 7. Contraindications or inability to perform spirometry 8. Necessity (in the Investigator's opinion) of prescribing mucolytic agents, expectorants, antibiotics or other medications prohibited by the protocol during the study 9. 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) 10. Malignant tumors in the past 5 years (except for the basal cell carcinoma) 11. 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 12. Gastric or duodenal ulcers, gastroesophageal reflux disease within a period of 12 months before screening 13. Systemic autoimmune disorders and connective tissue diseases that require (currently or previously) administration of systemic glucocorticosteroids, cytostatic medications or penicillamine 14. 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 15. History of alcohol or drug abuse at screening or in the past, which results in the inability of the patient to participate in the study at the Investigator's discretion 16. Taking part in another clinical trial or use of study drug within 30 days before screening 17. Pregnant or breast-feeding women or women planning pregnancy during the clinical trial; women of childbearing potential (including not sterilized operatively and in postmenopausal period of less than 2 years), not using appropriate methods of contraception 18. Inability to read or write; unwillingness to understand and follow the procedures of the study protocol; violation of the drug administration regimen or procedure execution that, at the discretion of the Investigator, can impact he results of the study or safety of the patient and interfere his further participation in the study; any other concomitant medical or serious mental conditions that make the patient unsuitable for participation in the clinical study, limit the validity of receiving an informed consent or may affect the patient's ability to participate in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Daytime Cough Resolution Rate by Day 8 in the PP Population | At Visit 3, Day 8 | 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. |
| Number of Participants With Daytime Cough Resolution Rate by Day 8 in the ITT Population | At Visit 3, Day 8 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| 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) | 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. |
| Number of Participants With Nighttime Cough Resolution Rate by Day 8 in the ITT Population | At Visit 3, Day 8 | 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. |
| Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) of the Various Severity According to Subjective Complaints | 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 | 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. |
| Change From Baseline in Pre-bronchodilator FEV1 Values on Day 8 in the ITT Population. | At Visit 3 (Day 8) | FEV1 is the Forced Expiratory Volume (in liters) in 1 second. The higher the value, the better the outcome. |
| Number of Participants With Daytime & Nighttime Cough Symptoms Resolution in the ITT Population | At Visit 2, Day 4 | 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. |
Countries
Russia
Participant flow
Recruitment details
Totally, 184 patients were randomized into Levopront® (Test) and the Libexin® (Control) treatment groups: there were 92 patients in each group. All the patients completed the study according to the protocol. One patient was screen failure due to post-bronchodilator FEV1 increase.
Participants by arm
| Arm | Count |
|---|---|
| Levopront® Syrup 30 mg/5 ml 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.
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). | 92 |
| Libexin® 100 mg Tablets Libexin® (prenoxdiazine) 100 mg tablets. Libexin® was administered orally, 1 tablet (100 mg) 3 times a day for 7 days.
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. | 92 |
| Total | 184 |
Baseline characteristics
| Characteristic | Libexin® 100 mg Tablets | Total | Levopront® Syrup 30 mg/5 ml |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 92 Participants | 184 Participants | 92 Participants |
| Age, Continuous | 40.2 years STANDARD_DEVIATION 13.4 | 40.2 years STANDARD_DEVIATION 12.42 | 40.2 years STANDARD_DEVIATION 11.4 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 92 Participants | 184 Participants | 92 Participants |
| Region of Enrollment Russia | 92 participants | 184 participants | 92 participants |
| Sex: Female, Male Female | 64 Participants | 124 Participants | 60 Participants |
| Sex: Female, Male Male | 28 Participants | 60 Participants | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 92 | 0 / 92 |
| other Total, other adverse events | 14 / 92 | 12 / 92 |
| serious Total, serious adverse events | 0 / 92 | 0 / 92 |
Outcome results
Primary
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
Population: ITT population: the population of patients based on the initial treatment assignment and not on the treatment eventually received.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Levopront® Syrup 30 mg/5 ml | Number of Participants With Daytime Cough Resolution Rate by Day 8 in the ITT Population | Ongoing (≥2) | 22 Participants |
| Levopront® Syrup 30 mg/5 ml | Number of Participants With Daytime Cough Resolution Rate by Day 8 in the ITT Population | Resolved (<2) | 70 Participants |
| Libexin® 100 mg Tablets | Number of Participants With Daytime Cough Resolution Rate by Day 8 in the ITT Population | Resolved (<2) | 65 Participants |
| Libexin® 100 mg Tablets | Number of Participants With Daytime Cough Resolution Rate by Day 8 in the ITT Population | Ongoing (≥2) | 27 Participants |
Comparison: Difference in daytime resolved rates Levopront® (Test) vs Libexin® (Control) was reported
Primary
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
Population: Per-Protocol population included all randomized patients completing treatment with the study drug, having primary efficacy analysis assessment done and considered to be compliant.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Levopront® Syrup 30 mg/5 ml | Number of Participants With Daytime Cough Resolution Rate by Day 8 in the PP Population | Resolved (<2) | 67 Participants |
| Levopront® Syrup 30 mg/5 ml | Number of Participants With Daytime Cough Resolution Rate by Day 8 in the PP Population | Ongoing (≥2) | 21 Participants |
| Libexin® 100 mg Tablets | Number of Participants With Daytime Cough Resolution Rate by Day 8 in the PP Population | Resolved (<2) | 64 Participants |
| Libexin® 100 mg Tablets | Number of Participants With Daytime Cough Resolution Rate by Day 8 in the PP Population | Ongoing (≥2) | 27 Participants |
Comparison: Difference in daytime resolved rates Levopront® (Test) vs Libexin® (Control) was reported
Secondary
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)
Population: ITT population: the population of patients is based on the initial treatment assignment and not on the treatment eventually received.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Levopront® Syrup 30 mg/5 ml | Change From Baseline in Cough Intensity According to the Visual-analogue Scale (VAS) in the ITT Population. | Visit 2, Day 4 | -28.9 units on a scale | Standard Deviation 15 |
| Levopront® Syrup 30 mg/5 ml | Change From Baseline in Cough Intensity According to the Visual-analogue Scale (VAS) in the ITT Population. | Visit 3, Day 8 | -52.1 units on a scale | Standard Deviation 18.1 |
| Libexin® 100 mg Tablets | Change From Baseline in Cough Intensity According to the Visual-analogue Scale (VAS) in the ITT Population. | Visit 2, Day 4 | -24.9 units on a scale | Standard Deviation 15 |
| Libexin® 100 mg Tablets | Change From Baseline in Cough Intensity According to the Visual-analogue Scale (VAS) in the ITT Population. | Visit 3, Day 8 | -44.6 units on a scale | Standard Deviation 17.8 |
Comparison: Visit 2, Day 4p-value: <0.001t-test, 1 sided
Comparison: at Visit 3, Day 8p-value: <0.001t-test, 1 sided
Secondary
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)
Population: ITT population: the population of patients is based on the initial treatment assignment and not on the treatment eventually received.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Levopront® Syrup 30 mg/5 ml | Change From Baseline in Pre-bronchodilator FEV1 Values on Day 8 in the ITT Population. | 0.0 liters | Standard Deviation 0.6 |
| Libexin® 100 mg Tablets | Change From Baseline in Pre-bronchodilator FEV1 Values on Day 8 in the ITT Population. | 0.1 liters | Standard Deviation 0.4 |
p-value: =0.336t-test, 1 sided
Secondary
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
Population: ITT population: the population of patients is based on the initial treatment assignment and not on the treatment eventually received.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Levopront® Syrup 30 mg/5 ml | 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 score at Visit 2, Day 4 | -1.2 units on a scale | Standard Deviation 0.8 |
| Levopront® Syrup 30 mg/5 ml | 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 score at Visit 3, Day 8 | -2.5 units on a scale | Standard Deviation 0.8 |
| Levopront® Syrup 30 mg/5 ml | 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 | nighttime cough score at Visit 2, Day 4 | -0.9 units on a scale | Standard Deviation 0.8 |
| Levopront® Syrup 30 mg/5 ml | 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 | nighttime cough score at Visit 3, Day 8 | -1.9 units on a scale | Standard Deviation 1.1 |
| Libexin® 100 mg Tablets | 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 | nighttime cough score at Visit 3, Day 8 | -1.9 units on a scale | Standard Deviation 1 |
| Libexin® 100 mg Tablets | 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 score at Visit 2, Day 4 | -1.2 units on a scale | Standard Deviation 0.6 |
| Libexin® 100 mg Tablets | 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 | nighttime cough score at Visit 2, Day 4 | -1.0 units on a scale | Standard Deviation 0.9 |
| Libexin® 100 mg Tablets | 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 score at Visit 3, Day 8 | -2.2 units on a scale | Standard Deviation 0.7 |
Comparison: Daytime at Visit 2, Day 4p-value: <0.001t-test, 1 sided
Comparison: Daytime at Visit 3, Day 8p-value: <0.001t-test, 2 sided
Comparison: Nightime at Visit 2, Day 4p-value: <0.001t-test, 1 sided
Comparison: Nighttime at Visit 3, Day 8p-value: <0.001t-test, 1 sided
Secondary
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
Population: Safety population: all patients who received at least one dose of the study drug will be included into the safety population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Levopront® Syrup 30 mg/5 ml | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) of the Various Severity According to Subjective Complaints | Patients with death outcome AE/SAE | 0 Participants |
| Levopront® Syrup 30 mg/5 ml | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) of the Various Severity According to Subjective Complaints | patients with AE/SAE | 14 Participants |
| Levopront® Syrup 30 mg/5 ml | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) of the Various Severity According to Subjective Complaints | Patients with mild and moderate AE/SAE | 14 Participants |
| Levopront® Syrup 30 mg/5 ml | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) of the Various Severity According to Subjective Complaints | Patients with related (possible, probable or highly probable) AE/SAE | 1 Participants |
| Levopront® Syrup 30 mg/5 ml | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) of the Various Severity According to Subjective Complaints | patients with SAE | 0 Participants |
| Levopront® Syrup 30 mg/5 ml | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) of the Various Severity According to Subjective Complaints | Patients with AE/SAE led to discontinuation | 0 Participants |
| Levopront® Syrup 30 mg/5 ml | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) of the Various Severity According to Subjective Complaints | Patients with severe AE/SAE | 0 Participants |
| Libexin® 100 mg Tablets | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) of the Various Severity According to Subjective Complaints | Patients with AE/SAE led to discontinuation | 0 Participants |
| Libexin® 100 mg Tablets | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) of the Various Severity According to Subjective Complaints | patients with AE/SAE | 12 Participants |
| Libexin® 100 mg Tablets | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) of the Various Severity According to Subjective Complaints | patients with SAE | 0 Participants |
| Libexin® 100 mg Tablets | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) of the Various Severity According to Subjective Complaints | Patients with mild and moderate AE/SAE | 12 Participants |
| Libexin® 100 mg Tablets | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) of the Various Severity According to Subjective Complaints | Patients with severe AE/SAE | 0 Participants |
| Libexin® 100 mg Tablets | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) of the Various Severity According to Subjective Complaints | Patients with related (possible, probable or highly probable) AE/SAE | 2 Participants |
| Libexin® 100 mg Tablets | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) of the Various Severity According to Subjective Complaints | Patients with death outcome AE/SAE | 0 Participants |
Secondary
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
Population: ITT population: the population of patients based on the initial treatment assignment and not on the treatment eventually received.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Levopront® Syrup 30 mg/5 ml | Number of Participants With Daytime & Nighttime Cough Symptoms Resolution in the ITT Population | Resolved (<2) | 22 Participants |
| Levopront® Syrup 30 mg/5 ml | Number of Participants With Daytime & Nighttime Cough Symptoms Resolution in the ITT Population | Ongoing (≥2) | 70 Participants |
| Libexin® 100 mg Tablets | Number of Participants With Daytime & Nighttime Cough Symptoms Resolution in the ITT Population | Resolved (<2) | 20 Participants |
| Libexin® 100 mg Tablets | Number of Participants With Daytime & Nighttime Cough Symptoms Resolution in the ITT Population | Ongoing (≥2) | 72 Participants |
p-value: =0.861Fisher Exact
Secondary
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
Population: ITT population: the population of patients based on the initial treatment assignment and not on the treatment eventually received.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Levopront® Syrup 30 mg/5 ml | Number of Participants With Nighttime Cough Resolution Rate by Day 8 in the ITT Population | Resolved (<2) | 90 Participants |
| Levopront® Syrup 30 mg/5 ml | Number of Participants With Nighttime Cough Resolution Rate by Day 8 in the ITT Population | Ongoing (≥2) | 2 Participants |
| Libexin® 100 mg Tablets | Number of Participants With Nighttime Cough Resolution Rate by Day 8 in the ITT Population | Resolved (<2) | 89 Participants |
| Libexin® 100 mg Tablets | Number of Participants With Nighttime Cough Resolution Rate by Day 8 in the ITT Population | Ongoing (≥2) | 3 Participants |
p-value: >0.999Fisher Exact