Efficacy and Safety of Polyoxidonium, Nasal and Sublingual Spray, 6 mg/ml in Children Aged 1-12 Years With ARI

NCT ID: NCT03840135

Last Updated: 2020-07-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 172 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-07
• Study Completion Date: 2019-12-10

Brief Summary

The purpose of this study is is to demonstrate superiority of Polyoxidonium, nasal and sublingual spray, 6 mg/ml over placebo in children aged from 1 to 12 years with acute respiratory viral infections. This is a multicenter prospective, randomized, double-blind, placebo-controlled, parallel-group phase 3 study.

Detailed Description

This is a multicenter prospective, randomized, double-blind, placebo-controlled, parallel-group phase 3 study to evaluate efficacy of Polyoxidonium spray 6 mg/ml on acute respiratory viral infections symptoms in children population. A study will last for 13 days (maximum) for each participant and will include 6 visits: Day 0 (Screening), Day 1, Day 3, Day 5, Day 8 ±1, Day 12 ±1. Express tests will be performed at the screening visit to exclude subjects with influenza or streptococcal infection. All eligible subjects will be treated with Polyoxidonium spray 6 mg/ml or placebo spray for 7 days. Clinical blood and urine tests will be performed at days 0 and 8 ±1. Symptom Assessment Scale (SAS) will be filled in at days 0, 1, 3, 5 and 8 ±1. Integrative Medicine Outcome Scale (IMOS) will be filled in by investigator and a parent/adopter at day 8 ±1. Adverse events information will be collected at days 1, 3, 8 ±1 and 12 ±1.

Conditions

Acute Respiratory Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Polyoxidonium 6 mg/ml

Polyoxidonium 6 mg/ml nasal and sublingual spray - 0,15 mg/kg daily - 7 days.

Group Type: EXPERIMENTAL

Polyoxidonium 6 mg/ml

Intervention Type: DRUG

Nasal and sublingual spray Polyoxidonium 6 mg/ml will be administered at a dose of 0,15 mg/kg daily for 7 days:

in children aged from 1 to 2 years - 1 spray sublingually 2 times a day (every 12 hours); in children aged from 2 to 5 years - 1 spray intranasally (in each nasal passage) 2 times a day (every 12 hours; in children aged from 5 to 8 years - 1 spray intranasally (in each nasal passage) 3 times a day (every 8 hours); in children aged from 8 to 12 years - 2 spray intranasally (in each nasal passage) 2 times a day (every 12 hours).

Placebo

Placebo, nasal and sublingual spray - 7 days.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo nasal and sublingual spray will be administered for 7 days:

in children aged from 1 to 2 years - 1 spray sublingually 2 times a day (every 12 hours); in children aged from 2 to 5 years - 1 spray intranasally (in each nasal passage) 2 times a day (every 12 hours; in children aged from 5 to 8 years - 1 spray intranasally (in each nasal passage) 3 times a day (every 8 hours); in children aged from 8 to 12 years - 2 spray intranasally (in each nasal passage) 2 times a day (every 12 hours).

Interventions

Polyoxidonium 6 mg/ml

Nasal and sublingual spray Polyoxidonium 6 mg/ml will be administered at a dose of 0,15 mg/kg daily for 7 days:

in children aged from 1 to 2 years - 1 spray sublingually 2 times a day (every 12 hours); in children aged from 2 to 5 years - 1 spray intranasally (in each nasal passage) 2 times a day (every 12 hours; in children aged from 5 to 8 years - 1 spray intranasally (in each nasal passage) 3 times a day (every 8 hours); in children aged from 8 to 12 years - 2 spray intranasally (in each nasal passage) 2 times a day (every 12 hours).

Intervention Type: DRUG

Placebo

Placebo nasal and sublingual spray will be administered for 7 days:

in children aged from 1 to 2 years - 1 spray sublingually 2 times a day (every 12 hours); in children aged from 2 to 5 years - 1 spray intranasally (in each nasal passage) 2 times a day (every 12 hours; in children aged from 5 to 8 years - 1 spray intranasally (in each nasal passage) 3 times a day (every 8 hours); in children aged from 8 to 12 years - 2 spray intranasally (in each nasal passage) 2 times a day (every 12 hours).

Intervention Type: OTHER

Other Intervention Names

Polyoxidonium, Nasal and Sublingual Spray, 6 mg/ml; Placebo, Nasal and Sublingual Spray

Eligibility Criteria

Inclusion Criteria

• Male and female patients aged 1 to 12 years
• Diagnosis of acute respiratory viral infection [International Classification of Diseases (10-th revision) codes: Acute nasopharyngitis [common cold], J02 Acute pharyngitis, J02.9 Acute pharyngitis, unspecified, J04 Acute laryngitis and tracheitis, J04.0 Acute laryngitis, J04.1 Acute tracheitis, J04.2 Acute laryngotracheitis, J06 Acute upper respiratory infections of multiple and unspecified sites, J06.0 Acute laryngopharyngitis, J06.9 Acute upper respiratory infection, unspecified] confirmed by physical examination: axillary temperature ≥ 37,0°C (measured at the moment of physical examination) and Symptoms Assessment Scale total score ≥5 points (not less than 3 of which should be related to ear, or nose, or throat, or upper respiratory tract affection symptoms).
• Less than 24 hours from the onset of disease (first respiratory viral infection symptoms)
• Informed consent signed by parent/adopter, or a child (applicable for children aged > 10 years)

Exclusion Criteria

• Suspicion on pneumonia, bacterial infection (including meningitis, sepsis, otitis media, sinusitis, sinusitis, urinary tract infection etc.) or a condition that requires antibacterial therapy from the first day of treatment.
• Suspicion on other diseases that may simulate acute respiratory viral infection at the moment of onset (other infectious diseases, flu-like syndrome in system collagen and other diseases).
• Positive express test for influenza or streptococcal infection.
• Clinical signs of serious acute respiratory viral infection, which requires hospitalization (fever ≥ 40°C, sings of airway obstruction, significant hemodynamic or neurological disorders).
• History of primary or secondary immunodeficiency.
• Cancer.
• Acute infectious and non-infectious diseases (except acute respiratory viral infection), exacerbation or decompensation of chronic diseases (diabetes mellitus, infantile cerebral paralysis, cystic fibrosis, primary ciliary dyskinesia, bronchopulmonary dysplasia, malformations of upper respiratory tract,ears, nose, or throat) which may affect an ability of patient to participate in study.
• Saccharase/isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption.
• History of allergy/hypersensitivity to any component of the study drug (including paracetamol, propacetamol hydrochloride).
• Use of protocol-prohibited medications within 1 month prior to study.
• Children, who's parents/adopters may fail to follow the protocol procedures and treatment, in investigator's opinion.
• Participation in other studies within 3 months to screening.
• Pregnancy.
• Any other medical or social condition that may interrupt study participation, in investigator's opinion.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NPO Petrovax

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nikolai Dodonov

Role: STUDY_CHAIR

NPO Petrovax

Locations

Medical Center "Medical Technology"

Saint Petersburg, Leningradskaya Oblast', Russia

Medical Center "MedAestheticCentre Laboratory"

Saint Petersburg, Leningradskaya Oblast', Russia

Medical center "Curator"

Saint Petersburg, Leningradskaya Oblast', Russia

Children's City Hospital No. 22

Saint Petersburg, Leningradskaya Oblast', Russia

Medical center "Korolev Medicine"

Naro-Fominsk, Moscow Oblast, Russia

City Children's Clinical Clinic №5

Perm, Perm Krai, Russia

Children's City Clinic №4 of the city of Rostov-on-Don

Rostov-on-Don, Rostov Oblast, Russia

Yaroslavl State Medical University

Yaroslavl, Yaroslavl Oblast, Russia

Regional Children's Clinical Hospital

Yaroslavl, Yaroslavl Oblast, Russia

Scientific Clinical Center of Otorhinolaryngology of the Federal Medical and Biological Agency

Moscow, , Russia

Federal state budgetary institution "Research Institute of Influenza" of Ministry of Health of Russia

Saint Petersburg, , Russia

Countries

Russia

References

Garashchenko TI, Karneeva OV, Tarasova GT, Kim IA, Hanferian RA (2020) Efficacy and safety of azoximer bromide (Polyoxidonium) in children aged from 1 to 12 years with ARI: The results of a multicenter prospective, randomized, double-blind, placebo-controlled, parallel-group study. Pediatr Dimensions 5: DOI: 10.15761/PD.1000204.

Reference Type: RESULT

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

PoArvi/PhIII_2017

Identifier Type: -

Identifier Source: org_study_id