- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03840135
Efficacy and Safety of Polyoxidonium, Nasal and Sublingual Spray, 6 mg/ml in Children Aged 1-12 Years With ARI
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 Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Moscow, Russian Federation, 123182
- Scientific Clinical Center of Otorhinolaryngology of the Federal Medical and Biological Agency
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Saint-Petersburg, Russian Federation, 197376
- Federal state budgetary institution "Research Institute of Influenza" of Ministry of Health of Russia
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Leningrad Region
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Saint Petersburg, Leningrad Region, Russian Federation, 192148
- Medical Center "Medical Technology"
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Saint Petersburg, Leningrad Region, Russian Federation, 192177
- Medical Center "MedAestheticCentre Laboratory"
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Saint Petersburg, Leningrad Region, Russian Federation, 196240
- Medical center "Curator"
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Saint Petersburg, Leningrad Region, Russian Federation, 196657
- Children's City Hospital No. 22
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Moscow Region
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Naro-Fominsk, Moscow Region, Russian Federation, 143300
- Medical center "Korolev Medicine"
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Perm Region
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Perm', Perm Region, Russian Federation, 614066
- City Children's Clinical Clinic №5
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Rostov Region
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Rostov-on-Don, Rostov Region, Russian Federation, 344065
- Children's City Clinic №4 of the city of Rostov-on-Don
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Yaroslavl Region
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Yaroslavl, Yaroslavl Region, Russian Federation, 150000
- Yaroslavl State Medical University
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Yaroslavl, Yaroslavl Region, Russian Federation, 150042
- Regional Children's Clinical Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Polyoxidonium 6 mg/ml
Polyoxidonium 6 mg/ml nasal and sublingual spray - 0,15 mg/kg daily - 7 days.
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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).
Other Names:
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PLACEBO_COMPARATOR: Placebo
Placebo, nasal and sublingual spray - 7 days.
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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).
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fever Duration (With a Superiority Cut-off Level δ=-0,52 Days)
Time Frame: Day 8±1
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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
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Day 8±1
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Intoxication Symptoms by 3 Day of Treatment Due to Symptom Assessment Scale (SAS)
Time Frame: Day 3
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A total number of patients (NP) without symptoms due to "General intoxication symptoms" domain of the Symptom Assessment Scale (SAS) was evaluated. A total number of patients (NP) with mild symptoms due to "General intoxication symptoms" domain of SAS (1 point according SAS) was evaluated. A total number of patients (NP) with moderate symptoms due to "General intoxication symptoms" domain of SAS (2 point according SAS) was be evaluated. A total number of patients (NP) with severe symptoms due to "General intoxication symptoms" domain of SAS (3 point according SAS) was evaluated. Domain "General intoxication symptoms" includes the following symptoms:
Each symptom may be graded by the following points:
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Day 3
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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
Time Frame: Day 3, Day 5
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Each symptom was graded by the following points:
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Day 3, Day 5
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Score on Symptoms: Nasal Discharge and Nasal Congestion/Impaired Nasal Airflow Due to Symptom Assessment Scale by 3 and 5 Day of Treatment
Time Frame: Day 3, Day 5
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Each symptom was graded by the following points:
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Day 3, Day 5
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Total Score on Symptom Assessment Scale by 3 and 5 Day of Treatment
Time Frame: Day 3, Day 5
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Symptom Assessment Scale (SAS) consists of 3 domains:
Each symptom may be graded by the following points:
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Day 3, Day 5
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Assessment of Treatment Results With Integrative Medicine Outcome Scale (IMOS) Performed by Investigator
Time Frame: Day 8±1
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Integrative Medicine Outcome Scale (IMOS) is used to assess treatment efficacy and has the following gradations of health condition: 0 points - absolute recovery;
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Day 8±1
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Assessment of Treatment Results With Integrative Medicine Outcome Scale (IMOS) Performed by Parent/Adopter
Time Frame: Day 8±1
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Integrative Medicine Outcome Scale (IMOS) is used to assess treatment efficacy and has the following gradations of health condition: 0 points - absolute recovery;
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Day 8±1
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Number of Cases of Antifebrile Agents Use
Time Frame: Day 8±1
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Number of cases of the antipyretic product (paracetamol) consumption for the entire study period
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Day 8±1
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Number of Patients Discontinued From the Study Due to Requirement for Antibacterial Therapy
Time Frame: Day 8±1
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Number of patients who discontinued from the study due to requirement for antibacterial therapy
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Day 8±1
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Number of Patients With Normalization of Body Temperature by 5 Day of Treatment
Time Frame: Day 5
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Axillary body temperature level ≤ 36,9 °C confirmed by two consecutive measurements (morning-evening/evening-morning will be considered as normalization of body temperature
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Day 5
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Number of Patients With Clinical Improvement (Symptom Assessment Scale Total Score ≤ 3) by 5 Day of Treatment
Time Frame: Day 5
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Symptom Assessment Scale (SAS) consists of 3 domains:
Each symptom may be graded by the following points:
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Day 5
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Nikolai Dodonov, NPO Petrovax
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PoArvi/PhIII_2017
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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