Clinical trial NCT03840135: Efficacy and Safety of Polyoxidonium, Nasal and Sublingual Spray, 6 mg/ml in Children Aged 1-12 Years With ARI
Official title: A Multicenter Prospective, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Polyoxidonium, Nasal and Sublingual Spray, 6 mg/ml in Children Aged From 1 to 12 Years With ARI (Acute Respiratory Infection)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Respiratory Infection
Keywords: ARI, acute respiratory infection
Lead sponsor: NPO Petrovax
Sponsor class: INDUSTRY
First posted: 2019-02-15
Enrollment: 172
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Fever Duration (With a Superiority Cut-off Level δ=-0,52 Days)
timeFrame: Day 8±1
Secondary outcomes:
measure: Changes in Intoxication Symptoms by 3 Day of Treatment Due to Symptom Assessment Scale (SAS)
timeFrame: Day 3
measure: 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
timeFrame: Day 3, Day 5
measure: Score on Symptoms: Nasal Discharge and Nasal Congestion/Impaired Nasal Airflow Due to Symptom Assessment Scale by 3 and 5 Day of Treatment
timeFrame: Day 3, Day 5
measure: Total Score on Symptom Assessment Scale by 3 and 5 Day of Treatment
timeFrame: Day 3, Day 5
measure: Assessment of Treatment Results With Integrative Medicine Outcome Scale (IMOS) Performed by Investigator
timeFrame: Day 8±1
measure: Assessment of Treatment Results With Integrative Medicine Outcome Scale (IMOS) Performed by Parent/Adopter
timeFrame: Day 8±1
measure: Number of Cases of Antifebrile Agents Use
timeFrame: Day 8±1
measure: Number of Patients Discontinued From the Study Due to Requirement for Antibacterial Therapy
timeFrame: Day 8±1
measure: Number of Patients With Normalization of Body Temperature by 5 Day of Treatment
timeFrame: Day 5
measure: Number of Patients With Clinical Improvement (Symptom Assessment Scale Total Score ≤ 3) by 5 Day of Treatment
timeFrame: Day 5
Other outcomes:
Locations:
city: Saint Petersburg
country: Russian Federation
facility: Medical Center "Medical Technology"
state: Leningrad Region
city: Saint Petersburg
country: Russian Federation
facility: Medical Center "MedAestheticCentre Laboratory"
state: Leningrad Region
city: Saint Petersburg
country: Russian Federation
facility: Medical center "Curator"
state: Leningrad Region
city: Saint Petersburg
country: Russian Federation
facility: Children's City Hospital No. 22
state: Leningrad Region
city: Naro-Fominsk
country: Russian Federation
facility: Medical center "Korolev Medicine"
state: Moscow Region
city: Perm'
country: Russian Federation
facility: City Children's Clinical Clinic №5
state: Perm Region
city: Rostov-on-Don
country: Russian Federation
facility: Children's City Clinic №4 of the city of Rostov-on-Don
state: Rostov Region
city: Yaroslavl
country: Russian Federation
facility: Yaroslavl State Medical University
state: Yaroslavl Region
city: Yaroslavl
country: Russian Federation
facility: Regional Children's Clinical Hospital
state: Yaroslavl Region
city: Moscow
country: Russian Federation
facility: Scientific Clinical Center of Otorhinolaryngology of the Federal Medical and Biological Agency
city: Saint-Petersburg
country: Russian Federation
facility: Federal state budgetary institution "Research Institute of Influenza" of Ministry of Health of Russia
Study officials:
affiliation: NPO Petrovax
name: Nikolai Dodonov
role: STUDY_CHAIR
References:
citation: 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.