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Study to assess the efficacy and safety of XC8, film-coated tablets, 10 mg in comparison with placebo in patients with dry non-productive cough against acute respiratory infections, and to determine the dosing regimen of XC8, film-coated tablets, 10 mg for treatment of dry non-productive cough against acute respiratory infections.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| XC8, film-coated tablets, 20 mg/day | Experimental |
| |
| XC8, film-coated tablets, 40 mg/day | Experimental |
| |
| XC8, film-coated tablets, 80 mg/day | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XC8, film-coated tablets, 20 mg/day | Drug | 20 mg/day (1 tablet twice a day) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Coughing frequency | Change in coughing frequency by ≥ -50% by day 5 relative to visit 1 | The estimate will include data from 24 hours to Day 1 and Day 5 |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of cough episodes | Frequency of cough episodes by 5, 8, 11, and 15 days after visit 1 | The assessment will include data for 24 h before days 5, 8, 11, and 15, respectively. |
| Time to clinical cough cure |
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Inclusion Criteria:
Exclusion Criteria:
Withdrawal Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ivanovo Kuvaev Clinical Hospital | Ivanovo | 153025 | Russia | |||
| Kirov State Medical University |
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| XC8, film-coated tablets, 40 mg/day | Drug | 40 mg/day (2 tablets twice a day) |
|
| XC8, film-coated tablets, 80 mg/day | Drug | 80 mg/day (4 tablets twice a day) |
|
| Placebo | Drug | 1, 2, or 4 tablets twice a day |
|
Time (days) from visit 1 to achievement of clinical cough cure. Clinical cough cure is defined as having ≤ 1 score on the Daytime Cough and Nighttime Cough Scales for at least 3 consecutive days.
| From Day 1 (visit 1) to the first day of consecutive days on which ≤ 1 point on the Daytime Cough and Nighttime Cough Scales sections of the Daytime and Nighttime Cough Scales is recorded, assessed up to Day 16 (visit 5). |
| Proportion of patients with ≤ 1 score on the daytime cough and nighttime cough Scales sections | Proportion of patients with ≤ 1 score on the daytime cough and nighttime cough Scales sections by days 5, 8, 11, and 15 after visit 1. | The daytime cough section score will include data for days 4, 7, 10, and 14, respectively. The nighttime cough section score will include data for the night preceding days 5, 8, 11, and 15, respectively. |
| Change (score) in cough severity | Change (score) in cough severity according to the digital rating scale (DRS) by days 5, 8, 11, and 15 compared to visit 1. | The score will include data 24 h before days 5, 8, 11, and 15, respectively. |
| Time (days) from visit 1 to a reduction in cough severity | Time (days) from visit 1 to a reduction in cough severity by DRS of ≥2 points. | From Day 1 (visit 1) up to Day 16 (visit 5). |
| Percentage of patients prescribed acetylcysteine | Percentage of patients who were prescribed acetylcysteine for the conversion of dry to wet cough. | From Day 1 (visit 1) up to Day 16 (visit 5). |
| Time (days) from visit 1 to administration of acetylcysteine | Estimated only in patients who were prescribed acetylcysteine. | From Day 1 (visit 1) up to Day 16 (visit 5). |
| Proportion of patients dropped out of the study due to prescription of systemic antibiotic therapy. | Proportion of patients dropped out of the study due to prescription of systemic antibiotic therapy due to the development of complications of the disease | From Day 1 (visit 1) up to Day 16 (visit 5). |
| Time (days) from visit 1 to achieving ≤ 1 score on the daytime cough | Time (days) from visit 1 to achieving ≤ 1 score on the daytime cough section Scales of daytime and nighttime cough. | From Day 1 (visit 1) up to Day 16 (visit 5). |
| Change (score) in daytime cough | Change (score) in daytime cough section Daytime and nighttime cough scales (from 0 - no cough episodes to 5 - severe cough, which makes normal activity impossible) by days 4, 7, 10, and 14 compared to visit 1. | Assessment will include data for days 4, 7, 10, and 14, respectively. |
| Proportion of patients with a score ≤ 1 on the daytime cough | Proportion of patients with a score ≤ 1 on the daytime cough section Daytime and nighttime cough scales by days 4, 7, 10, and 14 after visit 1. | Assessment will include data for days 4, 7, 10, and 14, respectively. |
| Percentage of patients with ≥1 point decrease in daytime cough | Percentage of patients with ≥1 point decrease in daytime cough section Daytime and nighttime cough scales by 4, 7, 10, and 14 days post-visit 1. | Assessment will include data for days 4, 7, 10, and 14, respectively. |
| Proportion of patients with ≥ 2 points reduction in daytime cough | Proportion of patients with ≥ 2 points reduction in "daytime cough" Scales of daytime and nighttime cough by 4, 7, 10, and 14 days after visit 1. | Assessment will include data for days 4, 7, 10, and 14, respectively. |
| Time (days) from visit 1 to reaching ≤ 1 score on the nighttime cough | Time (days) from visit 1 to reaching ≤ 1 score on the nighttime cough section Scales for daytime and nighttime cough. | From Day 1 (visit 1) up to Day 16 (visit 5). |
| Change (score) in the nighttime cough | Change (score) in the nighttime cough section Day and night cough scales (from 0 - no cough episodes to 5 - cough that prevents a subject from falling asleep) by days 5, 8, 11, and 15 compared to visit 1. | Assessment will include data for the night before days 5, 8, 11, and 15, respectively. |
| Proportion of patients with a score ≤ 1 on nighttime cough | Proportion of patients with a score ≤ 1 on nighttime cough Scales of day and night cough by days 5, 8, 11, and 15 after visit 1. | Assessment will include data for the night before days 5, 8, 11, and 15, respectively. |
| Percentage of patients with ≥1 point decrease in nighttime cough | Percentage of patients with ≥1 point decrease in nighttime cough section Scales of day and night cough by 5, 8, 11, and 15 days after visit 1. | Assessment will include data for the night before days 5, 8, 11, and 15, respectively. |
| Percentage of patients with a reduction of ≥ 2 points in the nighttime cough | Percentage of patients with a reduction of ≥ 2 points in the nighttime cough section Day and night cough scales by days 5, 8, 11, and 15 after visit 1. | Assessment will include data for the night before days 5, 8, 11, and 15, respectively. |
| Change in the number of episodes of nocturnal awakening due to cough | Change in the number of episodes of nocturnal awakening due to cough by days 5, 8, 11, and 15 compared to visit 1. | Assessment will include data for the night before days 5, 8, 11, and 15, respectively. |
| Time (days) to attain ≤ 1 score for each symptom | Time (days) to attain ≤ 1 score for each symptom on the Acute Respiratory Infection Major Symptom Rating Scale | From Day 1 (visit 1) up to Day 16 (visit 5). |
| Proportion of patients with attainment of ≤ 1 point on each symptom | Proportion of patients with attainment of ≤ 1 point on each symptom on the Acute Respiratory Infection Major Symptom Rating Scale by days 4, 7, 10, and 14 | Assessment will include data for days 4, 7, 10, and 14, respectively. |
| Percentage of patients with a decrease of ≥1 score on each symptom | Percentage of patients with a decrease of ≥1 score on each symptom on the Acute Respiratory Infection Major Symptom Rating Scale by days 4, 7, 10, and 14 | Assessment will include data for days 4, 7, 10, and 14, respectively. |
| Change in each symptom score | Change in each symptom score on the Acute Respiratory Infection Major Symptom Rating Scale by days 4, 7, 10, and 14 compared to visit 1. | Assessment will include data for days 4, 7, 10, and 14, respectively. |
| Proportion of patients with body temperature ≤ 37.0 °C | Proportion of patients with body temperature ≤ 37.0 °C by Visits 2-5. Patients who had a body temperature ≤ 37.0°C at Visit 1 will not be included in the analysis for that symptom. | From Day 3-4 (visit 2) up to Day 16 (visit 5). |
| Percentage of patients with complete resolution of all symptoms | Percentage of patients with complete resolution of all acute respiratory infection symptoms by days 4, 7, 10, and 14. | Assessment will include data for days 4, 7, 10, and 14, respectively. |
| Proportion of patients with "very high" and "high" efficacy | Proportion of patients with "very high" and "high" efficacy at visits 2, 3, 4, and 5 by physician's assessment. | From Day 3-4 (visit 2) up to Day 16 (visit 5). |
| Proportion of patients with each category of Global Assessment scale | Proportion of patients with each category of Global Assessment by the physician at visits 2, 3, 4, and 5. | From Day 3-4 (visit 2) up to Day 16 (visit 5). |
| Safety - Adverse Events (AEs) | Total number of AEs stratified by severity and frequency | From visit 0 up to Day 20 +/- 2 (visit 6). |
| Safety - Adverse Reactions | Frequency of Adverse Reactions | From visit 0 up to Day 20 +/- 2 (visit 6). |
| Safety - Serious adverse events (SAEs) | Frequency of SAEs associated with the use of the study drug/placebo | From visit 0 up to Day 20 +/- 2 (visit 6). |
| Safety - Percentage of patients with at least one AE | Percentage of patients with at least one AE | From visit 0 up to Day 20 +/- 2 (visit 6). |
| Safety - Percentage of patients who interrupted the treatment due to AE | Percentage of patients who interrupted the treatment due to the occurrence of AE | From visit 0 up to Day 20 +/- 2 (visit 6). |
| Kirov |
| 610027 |
| Russia |
| Unimed-C Jsc | Moscow | 119571 | Russia |
| Professors' Clinic LLC. | Perm | 614070 | Russia |
| EosMED JSC | Saint Petersburg | 194000 | Russia |
| Aurora MedFort LLC | Saint Petersburg | 194156 | Russia |
| Private Healthcare Institution Clinical Hospital "RZD-Medicine" of St. Petersburg | Saint Petersburg | 195271 | Russia |
| OrKli Hospital LLC. | Saint Petersburg | 199178 | Russia |
| Medical Diagnostic Center LLC. | Yaroslavl | 150000 | Russia |
| ID | Term |
|---|---|
| D003139 | Common Cold |
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| D009976 | Orthomyxoviridae Infections |
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