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 infection.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
250
80 mg/day: 4 tablets (40 mg) twice a day
4 tablets twice a day
Ivanovo Kuvaev Clinical Hospital
Ivanovo, Russia
Federal State Budgetary Educational Institution of Higher Education "Kirov State Medical University" of the Ministry of Healthcare of the Russian Federation
Kirov, Russia
Unimed-C Jsc
Moscow, Russia
EosMED JSC
Saint Petersburg, Russia
Coughing frequency
Reduced coughing frequency by ≥50% by day 5 relative to visit 1
Time frame: The estimate will include data from 24 hours to Day 1 and Day 5
Frequency of cough episodes
Frequency of cough episodes by 5, 8, 11, and 15 days after visit 1
Time frame: The assessment will include data for 24 h before days 5, 8, 11, and 15, respectively.
Time to clinical cough cure
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.
Time frame: The assessment will include the time from 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.
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
Time frame: 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.
Time frame: The score will include data 24 h before days 5, 8, 11, and 15, respectively.
Percentage of patients prescribed acetylcysteine
Percentage of patients who were prescribed acetylcysteine for the conversion of dry to wet cough.
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OrKli Hospital LLC.
Saint Petersburg, Russia
Uromed LLC
Smolensk, Russia
Time frame: From Day 1 (visit 1) 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: From visit 0 up to Day 20 +/- 2 (visit 6).
Safety - Adverse Reactions
Frequency of Adverse Reactions
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From visit 0 up to Day 20 +/- 2 (visit 6).