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

NCT03840135 | Completed Phase 3 Results

• 1 other identifier: PoArvi/PhIII_2017
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 11

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.

Conditions

Acute Respiratory Infection

Keywords

ARI, acute respiratory infection

Outcome Measures

Primary Outcomes (1)

• Fever Duration (With a Superiority Cut-off Level δ=-0,52 Days)

  Normalization of body temperature (axillary body temperature level ≤ 36,9 °C confirmed by two consecutive measurements (morning-evening/evening-morning)) will be considered as the end of fever

  Day 8±1

Secondary Outcomes (10)

• Changes in Intoxication Symptoms by 3 Day of Treatment Due to Symptom Assessment Scale (SAS)

  Day 3

• Number of Patients (NP) Without Nasal Discharge Symptom by 3 and 5 Day of Treatment, Number of Patients (NP) With Mild/Moderate/Severe Nasal Discharge Symptom by 3 and 5 Day of Treatment

  Day 3, Day 5

• Score on Symptoms: Nasal Discharge and Nasal Congestion/Impaired Nasal Airflow Due to Symptom Assessment Scale by 3 and 5 Day of Treatment

  Day 3, Day 5

• Total Score on Symptom Assessment Scale by 3 and 5 Day of Treatment

  Day 3, Day 5

• Assessment of Treatment Results With Integrative Medicine Outcome Scale (IMOS) Performed by Investigator

  Day 8±1

Study Arms (2)

Polyoxidonium 6 mg/ml

EXPERIMENTAL

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

Drug: Polyoxidonium 6 mg/ml

Placebo

PLACEBO COMPARATOR

Placebo, nasal and sublingual spray - 7 days.

Other: Placebo

Interventions

Polyoxidonium 6 mg/ml 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).

Also known as: Polyoxidonium, Nasal and Sublingual Spray, 6 mg/ml

Polyoxidonium 6 mg/ml

Placebo 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).

Also known as: Placebo, Nasal and Sublingual Spray

Placebo

Eligibility Criteria

• Age: 1 Year - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• NPO Petrovax: lead

Study Sites (11)

Medical Center "Medical Technology"

Saint Petersburg, Leningradskaya Oblast', 192148, Russia

Location

Medical Center "MedAestheticCentre Laboratory"

Saint Petersburg, Leningradskaya Oblast', 192177, Russia

Location

Medical center "Curator"

Saint Petersburg, Leningradskaya Oblast', 196240, Russia

Location

Children's City Hospital No. 22

Saint Petersburg, Leningradskaya Oblast', 196657, Russia

Location

Medical center "Korolev Medicine"

Naro-Fominsk, Moscow Oblast, 143300, Russia

Location

City Children's Clinical Clinic №5

Perm, Perm Krai, 614066, Russia

Location

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

Rostov-on-Don, Rostov Oblast, 344065, Russia

Location

Yaroslavl State Medical University

Yaroslavl, Yaroslavl Oblast, 150000, Russia

Location

Regional Children's Clinical Hospital

Yaroslavl, Yaroslavl Oblast, 150042, Russia

Location

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

Moscow, 123182, Russia

Location

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

Saint Petersburg, 197376, Russia

Location

Related Publications (1)

• 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.

  RESULT

MeSH Terms

Interventions

azoximer bromide

Results Point of Contact

• Title: Nikolay Dodonov, Head of medical department
• Organization: NPO Petrovax Pharm, LLC

DodonovNS@petrovax.ru

+7(495) 730-75-45

Study Officials

• Nikolai Dodonov

  NPO Petrovax

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: November 26, 2018
• First Posted: February 15, 2019
• Study Start: November 7, 2018
• Primary Completion: February 26, 2019
• Study Completion: December 10, 2019
• Last Updated: July 29, 2020
• Results First Posted: June 25, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

RU (11)