Rengalin liquid for dry cough in children aged 6 months to 3 years

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, double-blind, randomized, placebo-controlled, parallel-group phase 3 trial of Rengalin in a liquid form given orally as 5 ml three times daily for 7 days. The trial enrolls outpatients aged 6 months to under 3 years who have a dry (non-productive) cough of 24–72 hours' duration and a total cough severity score of 6 or more. At baseline parents complete the cough severity score, vital signs and physical exam are recorded, and at least 50% of participants will have basic blood and urine tests; safety and symptom outcomes are compared between Rengalin and placebo. The investigators will monitor cough severity and adverse events over the treatment period to determine efficacy and tolerability.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Outpatients of both genders aged over 6 months and under 3 years.
2. Clinically confirmed diagnosis of acute viral upper respiratory tract infections (acute pharyngitis, nasopharyngitis, tonsillitis, laryngitis, laryngotracheitis, tracheitis, acute viral respiratory infection of multiple and unspecified localization) during the epidemic growth of influenza and ARVI.
3. Dry (non-productive) cough lasting at least 24 hours but not more than 72 hours.
4. Total (day and night) cough severity score of 6 or more.
5. Availability of a patient information sheet and an informed consent form for participation in the clinical trial signed by one of the patient's parents/adoptive parents.

Exclusion Criteria:

1. Presence of the following diseases at the time of inclusion in the clinical trial:

   1.1 Inflammatory processes in the lower respiratory tract. 1.2 Grade III adenoid hypertrophy. 1.3 Chronic adenoiditis. 1.4 Postnasal drip syndrome. 1.5 Gastroesophageal reflux. 1.6 Bronchial asthma. 1.7 Cystic fibrosis. 1.8 Primary ciliary dyskinesia 1.9 Bronchopulmonary dysplasia 1.10 Malformations of the respiratory and ENT organs 1.11 Other chronic lung diseases. 1.12 Primary/secondary immunodeficiency. 1.13 Oncological disease of any localization.
2. Suspected bacterial infection of any localization, including pneumonia, sinusitis, otitis media.
3. Allergic rhinitis.
4. Bronchial obstruction syndrome.
5. Acute obstructive laryngitis \[croup\] and epiglottitis.
6. Congenital heart defects with hypervolemia in pulmonary circulation.
7. Acute respiratory failure.
8. Inflammatory, degenerative, demyelinating diseases of the central nervous system, polyneuropathies, epilepsy.
9. Exacerbation or decompensation of chronic diseases affecting the patient's ability to participate in a clinical trial.
10. Presence of allergy/hypersensitivity to any components of the medicines used in the treatment.
11. Taking medications listed in the section "Prohibited Concomitant Therapy" within 4 weeks prior to inclusion in the study.
12. Patients whose parents/adoptive parents, from the investigator's point of view, will not comply with observation requirements during the study or with the administration of study drugs.
13. Participation in other clinical trials within 3 months prior to inclusion in this trial.
14. A patient's parent/adoptive parent is related to on-site research personnel directly involved in the trial, or is the immediate family member of the investigator. 'Immediate family members' mean spouses, parents, children, or siblings, whether related or adopted.
15. The patient's parent/adoptive parent is employed by OOO "NPF "MATERIA MEDICA HOLDING", i.e., is an employee of the company, a temporary contract employee, or a designated official responsible for conducting the trial or their immediate family member.

Where it's running

• Gatchina Clinical Interdistrict Hospital
  Gatchina, Russia Recruiting
• Llc "Medlight"
  Kazan', Russia Recruiting
• Specialized Clinical Infectious Diseases Hospital
  Krasnodar, Russia Recruiting
• Central Research Institute of Epidemiology
  Moscow, Russia Recruiting
• First Moscow State Medical University named after I.M. Sechenov
  Moscow, Russia Recruiting
• City Children's Clinical Polyclinic # 5
  Perm, Russia Recruiting

Study contacts

• Study coordinator: Mikhail Putilovskiy, MD,PhD
• Email: PutilovskiyMA@materiamedica.ru
• Phone: +74952761571

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.