Efficacy and Safety of XC8, Film-coated Tablets, in Children With Acute Respiratory Viral Infections

NCT06379542 | Recruiting Phase 3

• 1 other identifier: XC8-03-05-2023
• Study Type: interventional
• Target: 252
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Acute Respiratory Infection

Outcome Measures

Primary Outcomes (1)

• 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

  Assessment will include data collected within 24 hours before day 1 and day 5

Secondary Outcomes (12)

• Number of cough attacks by day 5, day 8, day 11 and day 15

  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

  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

  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.

• Change (score) in cough severity by digital rating scale 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

• Percentage of patients needed acetylcysteine

  Day 1 - Day 21±2

Study Arms (2)

XC8, film-coated tablets, 20 mg, 40 mg

EXPERIMENTAL

6-12 years old: 20 mg tablet, 2 per day for 7-14 days on top of standard therapy. 13-17 years old: 40 mg tablet, 2 per day for 7-14 days on top of standard therapy.

Drug: XC8

Placebo

PLACEBO COMPARATOR

2 tablets per day for 7-14 days on top of standard therapy

Drug: Placebo

Interventions

XC8 DRUG

40 mg/day or 80 mg/day for 7-14 days

XC8, film-coated tablets, 20 mg, 40 mg

Placebo DRUG

2 tablets/day for 7-14 days

Placebo

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patient signing the Informed Consent Form and parent/adoptive parent signing the Parent/Adoptive Informed Consent Form.
• Male and female children between the ages of 6 and 17 years 10 months inclusive at the time of screening.
• Clinical diagnosis of acute respiratory viral upper respiratory tract infection (J00-J06 according to ICD-10) or acute bronchitis (J20, J21 according to ICD-10).
• Onset of disease symptoms no more than 3 days prior to screening.
• Presence of dry non-productive cough in the patient.
• Frequency of cough attacks ≥10 in the last 24 h before the screening visit and randomization.
• Cough frequency rated by the patient (for patients 13-17 years of age) or parent/adoptive parent (for patients 6-12 years of age) as 3-4 points on the "daytime cough" section and 2-4 points on the "nighttime cough" Daytime and nighttime cough scales.
• Patient (for patients 13-17 years of age) or parent/adoptive parent (for patients 6-12 years of age) assessment of cough severity on the digital rating scale as ≥4 points.
• For patients 14-17 years of age inclusive, consent to use reliable contraceptive methods throughout study participation and for 3 weeks after the end of the study.
• Reliable contraceptive methods are: sexual rest, condom use in combination with spermicide.
• Known or suspected hypersensitivity to the active substance or any of the excipients of the study drug/placebo.
• Known or suspected hypersensitivity to acetylcysteine.
• Lactose intolerance, lactase deficiency, glucose-galactose malabsorption.
• Trauma (including open wounds in the oral cavity and erosive desquamous lesions of the oral mucosa) and/or burns of the oropharynx, scarlet fever, rubella, measles, epidemic mumps at the time of screening or within 3 months before screening.
• Acute obstructive laryngitis or suspected obstructive laryngitis.

You may not qualify if:

• Identification of a confirmed case of COVID-19.
• Ineffectiveness of therapy - persistence or increase in cough attack frequency ≥1 by Visit 3 (Day 8-9) compared to Visit 1 (Day 1).
• Adverse events (AEs) requiring withdrawal of study drug/placebo.
• Occurrence of any disease or condition during the study that, in the opinion of the investigator, worsens the patient's prognosis and makes it impossible for the patient to continue participating in the clinical trial.
• Taking any of the drugs of prohibited therapy, performing a prohibited procedure.
• Need to prescribe a prohibited concomitant therapy/procedure.
• Pregnancy of the patient.
• Willingness of the patient and/or his/her parent/adoptive parent to terminate the patient's participation in the study.
• Lack of adequate cooperation of the patient and/or his/her parent/adoptive parent with the physician-researcher during the research process.
• Other protocol violations that in the opinion of the physician-researcher are significant.
• Other administrative reasons.

Sponsors & Collaborators

• Valenta Pharm JSC: lead

Study Sites (6)

City Pediatric Outpatient Clinic number 5

Perm, 614066, Russia

RECRUITING

Professors' Clinic LLC.

Perm, 614070, Russia

RECRUITING

St. Petersburg State Budgetary Healthcare Institution "City Polyclinic No. 44"

Saint Petersburg, 192071, Russia

RECRUITING

ArsVite North-West, LLC

Saint Petersburg, 194223, Russia

RECRUITING

PiterKlinika LLC

Saint Petersburg, 196158, Russia

RECRUITING

St. Petersburg State Budgetary Healthcare Institution "City Pediatric Polyclinic No. 35"

Saint Petersburg, 196191, Russia

RECRUITING

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2024
• First Posted: April 23, 2024
• Study Start: December 4, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 23, 2024

Record last verified: 2024-04

Locations

RU (6)