Efficacy and Safety of Polyoxidonium, Nasal and Sublingual Spray, 6 mg/ml in Children Aged 1-12 Years With ARI
Condition: Acute Respiratory Infection
MeSH terms: Infections; Respiratory Tract Infections
Intervention: Polyoxidonium 6 mg/ml; Placebo
Intervention description: 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 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).
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 172.0
Sex: All
Minimum age: 1 Year
Maximum age: 12 Years
Healthy volunteers: No
Keywords: ARI, acute respiratory infection

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.
    

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.