The study is planned to evaluate the therapeutic efficacy and safety of XC8, film-coated tablets, in the treatment of dry non-productive cough on the background of acute respiratory infections in children from 6 to 17 years compared with placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
252
City Pediatric Outpatient Clinic number 5
Perm, Russia
RECRUITINGProfessors' Clinic LLC.
Perm, Russia
RECRUITINGSt. Petersburg State Budgetary Healthcare Institution "City Polyclinic No. 44"
Saint Petersburg, Russia
Decrease in percentage of patients with ≥50% reduction in number of cough attacs by day 5 relative to day 1
Difference between the percentage of patients with ≥50% reduction in number of cough attacs by day 5 and by day 1
Time frame: Assessment will include data collected within 24 hours before day 1 and day 5
Number of cough attacks by day 5, day 8, day 11 and day 15
Number of cough attacks registered by days 5, 8, 11, and 15
Time frame: The estimate will include data collected within 24 hours before day 5, day 8, day 11 and day 15, respectively
Time (days) from visit 1 until clinical cough cure is achieved
Clinical cure of cough is defined as having ≤ 1 score on the "daytime cough" and "nighttime cough" sections of the Daytime and Nighttime Cough Scale (a scale with scores from 0 to 5, where 0 is the absence of cough, and 5 is a severe cough that makes daytime activity impossible or a cough that makes it impossible to sleep) for at least 3 consecutive days.
Time frame: The assessment will include the time from visit 1 to the first day of consecutive days on which ≤ 1 score on the "daytime cough" and "nighttime cough" sections of the scales is recorded through the end of treatment (within timeframe from 7 to 14 days)
Proportion of patients with presence of ≤ 1 score for the "daytime cough" and "nighttime cough" sections Daytime and nighttime cough scales by days 5, 8, 11, and 15 after visit 1
Score on the "daytime cough" and "nighttime cough" sections of the Daytime and Nighttime Cough Scale (a scale with scores from 0 to 5, where 0 is the absence of cough, and 5 is a severe cough that makes daytime activity impossible or a cough that makes it impossible to sleep)
Time frame: The score for the "daytime cough" section will include data for days 4, 7, 10, and 14, respectively. The score for the "night cough" section will include data from the night prior to days 5, 8, 11, and 15, respectively.
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ArsVite North-West, LLC
Saint Petersburg, Russia
RECRUITINGPiterKlinika LLC
Saint Petersburg, Russia
RECRUITINGSt. Petersburg State Budgetary Healthcare Institution "City Pediatric Polyclinic No. 35"
Saint Petersburg, Russia
RECRUITINGChange (score) in cough severity by digital rating scale by days 5, 8, 11 and 15 compared to visit 1
Score assessed with digital rating scale (a scale from 0 to 10, where 0 is the absence of cough, and 10 is the most excruciating cough imaginable)
Time frame: The score will include data 24 h before days 5, 8, 11 and 15, respectively
Percentage of patients needed acetylcysteine
Percentage of patients who were prescribed a preparation with acetylcysteine for transition of dry cough to wet cough
Time frame: Day 1 - Day 21±2
Proportion of patients with complete resolution of all symptoms of acute respiratory infection by days 4, 7, 10 and 14
Complete resolution of all symptoms is defined as achieving a score of 0 for each symptom on the Basic Symptom Rating Scale for acute respiratory infections (a 6-item inventory including Fatigue, Sore throat, Nasal congestion, Rhinorrhea, Myalgia, and Headache, assessed using a score from 0 to 3, where 0 is the absence of the symptom, and 3 is the most severe symptom severity)
Time frame: Days 4, 7, 10, 14
Percentage of patients with each category of Global Physician-Researcher Assessment of Therapy Effectiveness at visits 2, 3, 4, and 5
Assessment of clinical effectiveness using Global Physician-Researcher Assessment of Therapy Effectiveness (a 5-point scale, where 1 is the absence of efficacy, and 5 is very high efficiency, meaning a complete cure of coughs)
Time frame: Day 3-16
Number of adverse events (AEs)
Total number of AEs stratified by severity and frequency
Time frame: Day 0 - Day 21±2
Adverse reactions
Frequency of adverse reactions
Time frame: Day 0 - Day 21±2
Serious adverse events (SAEs)
Frequency of serious adverse events (SAEs) associated with study drug/placebo use
Time frame: Day 0 - Day 21±2
Percentage of patients with AEs
Percentage of patients with at least one AE
Time frame: Day 0 - Day 21±2
Percentage of patients who interrupted treatment
Percentage of patients who interrupted treatment due to AE
Time frame: Day 0 - Day 21±2