Evaluating XC8 tablets for treating cough in children with respiratory infections

Double-blind Placebo-controlled Multicenter Randomized Clinical Trial to Evaluate the Efficacy and Safety of XC8, Film-coated Tablets (Valenta Pharm JSC, Russia), in Children Aged 6-17 Years With Dry Non-productive Cough Against the Background of Acute Respiratory Viral Infection

This study is testing if XC8 tablets can help children aged 6 to 17 with a dry cough from respiratory infections feel better compared to a placebo.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 252 (estimated)
• Ages: 6 Years to 17 Years
• Sex: All
• Sponsor: Valenta Pharm JSC (Industry-sponsored)
• Locations: 6 sites (Perm and 5 other locations)
• Trial ID: NCT06379542 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the efficacy and safety of XC8, a film-coated tablet, in treating dry non-productive cough associated with acute respiratory viral infections in children aged 6 to 17 years. Participants will be randomly assigned to receive either XC8 or a placebo, with the study focusing on the frequency and severity of cough symptoms. The trial will include children who have shown symptoms of respiratory infections for no more than three days prior to screening and have a specific cough frequency. The outcomes will help determine if XC8 is a beneficial treatment option compared to placebo.

Who should consider this trial

Good fit: Ideal candidates for this study are children aged 6 to 17 years with a clinical diagnosis of acute respiratory viral infections and a significant dry cough.

Not a fit: Patients with other underlying respiratory conditions or those who do not have a dry non-productive cough may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide an effective option for alleviating cough symptoms in children suffering from acute respiratory infections.

How similar studies have performed: While there have been studies on cough treatments, the specific use of XC8 in this context is novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

1. Patient signing the Informed Consent Form and parent/adoptive parent signing the Parent/Adoptive Informed Consent Form.
2. Male and female children between the ages of 6 and 17 years 10 months inclusive at the time of screening.
3. 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).
4. Onset of disease symptoms no more than 3 days prior to screening.
5. Presence of dry non-productive cough in the patient.
6. Frequency of cough attacks ≥10 in the last 24 h before the screening visit and randomization.
7. 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.
8. 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.
9. No indication for therapy due to BHSA infection at the time of inclusion in the study: negative rapid test for group A β-hemolytic streptococcus.
10. 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.

Non-inclusion Criteria:

1. Known or suspected hypersensitivity to the active substance or any of the excipients of the study drug/placebo.
2. Known or suspected hypersensitivity to acetylcysteine.
3. Lactose intolerance, lactase deficiency, glucose-galactose malabsorption.
4. 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.
5. Acute obstructive laryngitis or suspected obstructive laryngitis.
6. Presence of signs of laryngeal stenosis (stridor, dyspnea).
7. Exacerbation of chronic bronchitis.
8. Bronchial asthma, including history.
9. Tuberculosis in the anamnesis.
10. Emphysema of the lungs in the anamnesis.
11. Acute or chronic pneumonia or suspected pneumonia.
12. Condition after intubation.
13. Gastroesophageal reflux being the primary cause of cough (in the opinion of the investigating physician).
14. Allergic rhinitis being the primary cause of cough (in the opinion of the physician-researcher).
15. Body temperature \> 39.0 °C.
16. Positive laboratory test result for SARS-CoV-2 antigen using an immunochromatographic assay at the time of screening1.
17. Need for systemic antibiotic therapy and/or other drugs/procedures on the prohibited therapy/procedure list.
18. Use of analgesics or antipyretics within 12 h prior to screening.
19. Use of glucocorticosteroids, β-adrenoblockers, ACE inhibitors, theophylline preparations, expectorants, cough suppressants, anesthetics, anti-allergic drugs (leukotriene receptor antagonists, H1-histamine receptor blockers, sodium cromoglycate preparations), antiviral drugs, immunosuppressants, systemic antibacterial agents within 7 days before screening.
20. A history of smoking.
21. History of renal or hepatic impairment.
22. History of oncologic diseases.
23. Serious cardiovascular disease at the time of screening or within 12 months prior to screening, including: severe arrhythmias requiring treatment with antiarrhythmic drugs, unstable angina pectoris, heart and coronary artery surgery, stroke.
24. Other severe, decompensated or unstable somatic diseases (any disease or condition that threatens the patient's life or worsens the patient's prognosis and makes it impossible for the patient to participate in the clinical trial).
25. Unwillingness or inability of the patient/parent/adoptive parent to comply with the protocol procedures (in the opinion of the investigating physician).
26. Pregnancy or breastfeeding period (for female patients).
27. Alcoholism, drug dependence, substance abuse history and/or at the time of screening.
28. A history of schizophrenia, schizoaffective disorder, bipolar disorder, or other psychiatric pathology.
29. Participation in another clinical trial within 3 months prior to inclusion in the study.
30. Other conditions that, in the opinion of the investigating physician, preclude the patient's inclusion in the study.

Exclusion criteria:

1. Identification of a confirmed case of COVID-19.
2. Ineffectiveness of therapy - persistence or increase in cough attack frequency ≥1 by Visit 3 (Day 8-9) compared to Visit 1 (Day 1).
3. Adverse events (AEs) requiring withdrawal of study drug/placebo.
4. 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.
5. Erroneous inclusion of a patient who does not meet the inclusion criteria and/or meets the criteria for non-inclusion.
6. Taking any of the drugs of prohibited therapy, performing a prohibited procedure.
7. Need to prescribe a prohibited concomitant therapy/procedure.
8. Pregnancy of the patient.
9. Willingness of the patient and/or his/her parent/adoptive parent to terminate the patient's participation in the study.
10. Lack of adequate cooperation of the patient and/or his/her parent/adoptive parent with the physician-researcher during the research process.
11. Other protocol violations that in the opinion of the physician-researcher are significant.
12. Other administrative reasons.

Where this trial is running

Perm and 5 other locations

• City Pediatric Outpatient Clinic number 5 — Perm, Russian Federation (Recruiting)
• Professors' Clinic LLC. — Perm, Russian Federation (Recruiting)
• St. Petersburg State Budgetary Healthcare Institution "City Polyclinic No. 44" — Saint Petersburg, Russian Federation (Recruiting)
• ArsVite North-West, LLC — Saint Petersburg, Russian Federation (Recruiting)
• PiterKlinika LLC — Saint Petersburg, Russian Federation (Recruiting)
• St. Petersburg State Budgetary Healthcare Institution "City Pediatric Polyclinic No. 35" — Saint Petersburg, Russian Federation (Recruiting)

Conditions Acute Respiratory Infection