Back to resultsEfficacy and Safety of Polyoxidonium, Nasal and Sublingual Spray, 6 mg/ml in Children Aged 1-12 Years With ARI
Primary Purpose
Acute Respiratory Infection
Status
Completed
Phase
Phase 3
Locations
Russian Federation
Study Type
Interventional
Intervention
Polyoxidonium 6 mg/ml
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Acute Respiratory Infection focused on measuring ARI, acute respiratory infection
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.
Sites / Locations
- Medical Center "Medical Technology"
- Medical Center "MedAestheticCentre Laboratory"
- Medical center "Curator"
- Children's City Hospital No. 22
- Medical center "Korolev Medicine"
- City Children's Clinical Clinic №5
- Children's City Clinic №4 of the city of Rostov-on-Don
- Yaroslavl State Medical University
- Regional Children's Clinical Hospital
- Scientific Clinical Center of Otorhinolaryngology of the Federal Medical and Biological Agency
- Federal state budgetary institution "Research Institute of Influenza" of Ministry of Health of Russia
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Polyoxidonium 6 mg/ml
Placebo
Arm Description
Polyoxidonium 6 mg/ml nasal and sublingual spray - 0,15 mg/kg daily - 7 days.
Placebo, nasal and sublingual spray - 7 days.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Changes in Intoxication Symptoms by 3 Day of Treatment Due to Symptom Assessment Scale (SAS)
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:
altered/decreased activity;
altered appetite;
unhealthy appearance;
altered or interrupted sleep.
Each symptom may be graded by the following points:
0 points - absent;
1 point - mild;
2 points - moderate;
3 points - severe.
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
Each symptom was graded by the following points:
0 points - absent;
1 point - mild;
2 points - moderate;
3 points - severe. Number of patients (NP) without nasal discharge symptom by 3 and 5 day of treatment (score on the scale 0 point), Number of patients (NP) with mild nasal discharge symptom by 3 and 5 day of treatment (score on the scale 1 points) Number of patients (NP) with moderate nasal discharge symptom by 3 and 5 day of treatment (score on the scale 2 points) Number of patients (NP) with severe nasal discharge symptom by 3 and 5 day of treatment (score on the scale 3 points)
Score on Symptoms: Nasal Discharge and Nasal Congestion/Impaired Nasal Airflow Due to Symptom Assessment Scale by 3 and 5 Day of Treatment
Each symptom was graded by the following points:
0 points - absent;
1 point - mild;
2 points - moderate;
3 points - severe. The higher scores mean worse outcome. The maximum score is 3 points, the minimum score is 0 points.
Total Score on Symptom Assessment Scale by 3 and 5 Day of Treatment
Symptom Assessment Scale (SAS) consists of 3 domains:
Domain "General intoxication symptoms" (altered/increased activity/dysfunctional behavior; altered appetite or food refusal; unhealthy or alter from common appearance; altered or interrupted sleep);
"Nose symptoms" (nasal discharge; nasal congestion/impaired nasal airflow; sneezing);
"Throat and thoracic symptoms" (hoarseness; sore throat; cough).
Each symptom may be graded by the following points:
0 points - absent;
1 point - mild;
2 points - moderate;
3 points - severe. The higher scores mean a worse outcome. The total score is the sum of points of each symptom graded in Symptom Assessment Scale. The maximum possible value of the total score is 30 points, the minimum possible value of the total score is 0 points.
Assessment of Treatment Results With Integrative Medicine Outcome Scale (IMOS) Performed by Investigator
Integrative Medicine Outcome Scale (IMOS) is used to assess treatment efficacy and has the following gradations of health condition:
0 points - absolute recovery;
point - significant improvement;
points - slight to moderate improvement;
points - unchanged;
points - decline. The results is presented in number of patients with 0 points (absolute recovery), number of patients with 1 points (significant improvement), number of patients with 2 points (slight to moderate improvement), number of patients with 3 points (unchanged), number ot patients with 4 points (decline) by day 8 according IMOS.
Assessment of Treatment Results With Integrative Medicine Outcome Scale (IMOS) Performed by Parent/Adopter
Integrative Medicine Outcome Scale (IMOS) is used to assess treatment efficacy and has the following gradations of health condition:
0 points - absolute recovery;
point - significant improvement;
points - slight to moderate improvement;
points - unchanged;
points - decline. The results is presented in number of patients with 0 points (absolute recovery), number of patients with 1 points (significant improvement), number of patients with 2 points (slight to moderate improvement), number of patients with 3 points (unchanged), number ot patients with 4 points (decline) by day 8 according IMOS.
Number of Cases of Antifebrile Agents Use
Number of cases of the antipyretic product (paracetamol) consumption for the entire study period
Number of Patients Discontinued From the Study Due to Requirement for Antibacterial Therapy
Number of patients who discontinued from the study due to requirement for antibacterial therapy
Number of Patients With Normalization of Body Temperature by 5 Day of Treatment
Axillary body temperature level ≤ 36,9 °C confirmed by two consecutive measurements (morning-evening/evening-morning will be considered as normalization of body temperature
Number of Patients With Clinical Improvement (Symptom Assessment Scale Total Score ≤ 3) by 5 Day of Treatment
Symptom Assessment Scale (SAS) consists of 3 domains:
Domain "General intoxication symptoms" (altered/increased activity/dysfunctional behavior; altered appetite or food refusal; unhealthy or alter from common appearance; altered or interrupted sleep);
"Nose symptoms" (nasal discharge; nasal congestion; impaired nasal airflow; sneezing);
"Throat and thoracic symptoms" (hoarseness; sore throat; cough). The higher scores mean a worse outcome. The total score is the sum of points of each symptom graded in Symptom Assessment Scale. The maximum possible value of the total score is 30 points, the minimum possible value of the total score is 0 points.
Each symptom may be graded by the following points:
0 points - absent;
1 point - mild;
2 points - moderate;
3 points - severe.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03840135
Brief Title
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
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
November 7, 2018 (Actual)
Primary Completion Date
February 26, 2019 (Actual)
Study Completion Date
December 10, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NPO Petrovax
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Infection
Keywords
ARI, acute respiratory infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
172 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Polyoxidonium 6 mg/ml
Arm Type
Experimental
Arm Description
Polyoxidonium 6 mg/ml nasal and sublingual spray - 0,15 mg/kg daily - 7 days.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo, nasal and sublingual spray - 7 days.
Intervention Type
Drug
Intervention Name(s)
Polyoxidonium 6 mg/ml
Other Intervention Name(s)
Polyoxidonium, Nasal and Sublingual Spray, 6 mg/ml
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).
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo, Nasal and Sublingual Spray
Intervention Description
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).
Primary Outcome Measure Information:
Title
Fever Duration (With a Superiority Cut-off Level δ=-0,52 Days)
Description
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
Time Frame
Day 8±1
Secondary Outcome Measure Information:
Title
Changes in Intoxication Symptoms by 3 Day of Treatment Due to Symptom Assessment Scale (SAS)
Description
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:
altered/decreased activity;
altered appetite;
unhealthy appearance;
altered or interrupted sleep.
Each symptom may be graded by the following points:
0 points - absent;
1 point - mild;
2 points - moderate;
3 points - severe.
Time Frame
Day 3
Title
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
Description
Each symptom was graded by the following points:
0 points - absent;
1 point - mild;
2 points - moderate;
3 points - severe. Number of patients (NP) without nasal discharge symptom by 3 and 5 day of treatment (score on the scale 0 point), Number of patients (NP) with mild nasal discharge symptom by 3 and 5 day of treatment (score on the scale 1 points) Number of patients (NP) with moderate nasal discharge symptom by 3 and 5 day of treatment (score on the scale 2 points) Number of patients (NP) with severe nasal discharge symptom by 3 and 5 day of treatment (score on the scale 3 points)
Time Frame
Day 3, Day 5
Title
Score on Symptoms: Nasal Discharge and Nasal Congestion/Impaired Nasal Airflow Due to Symptom Assessment Scale by 3 and 5 Day of Treatment
Description
Each symptom was graded by the following points:
0 points - absent;
1 point - mild;
2 points - moderate;
3 points - severe. The higher scores mean worse outcome. The maximum score is 3 points, the minimum score is 0 points.
Time Frame
Day 3, Day 5
Title
Total Score on Symptom Assessment Scale by 3 and 5 Day of Treatment
Description
Symptom Assessment Scale (SAS) consists of 3 domains:
Domain "General intoxication symptoms" (altered/increased activity/dysfunctional behavior; altered appetite or food refusal; unhealthy or alter from common appearance; altered or interrupted sleep);
"Nose symptoms" (nasal discharge; nasal congestion/impaired nasal airflow; sneezing);
"Throat and thoracic symptoms" (hoarseness; sore throat; cough).
Each symptom may be graded by the following points:
0 points - absent;
1 point - mild;
2 points - moderate;
3 points - severe. The higher scores mean a worse outcome. The total score is the sum of points of each symptom graded in Symptom Assessment Scale. The maximum possible value of the total score is 30 points, the minimum possible value of the total score is 0 points.
Time Frame
Day 3, Day 5
Title
Assessment of Treatment Results With Integrative Medicine Outcome Scale (IMOS) Performed by Investigator
Description
Integrative Medicine Outcome Scale (IMOS) is used to assess treatment efficacy and has the following gradations of health condition:
0 points - absolute recovery;
point - significant improvement;
points - slight to moderate improvement;
points - unchanged;
points - decline. The results is presented in number of patients with 0 points (absolute recovery), number of patients with 1 points (significant improvement), number of patients with 2 points (slight to moderate improvement), number of patients with 3 points (unchanged), number ot patients with 4 points (decline) by day 8 according IMOS.
Time Frame
Day 8±1
Title
Assessment of Treatment Results With Integrative Medicine Outcome Scale (IMOS) Performed by Parent/Adopter
Description
Integrative Medicine Outcome Scale (IMOS) is used to assess treatment efficacy and has the following gradations of health condition:
0 points - absolute recovery;
point - significant improvement;
points - slight to moderate improvement;
points - unchanged;
points - decline. The results is presented in number of patients with 0 points (absolute recovery), number of patients with 1 points (significant improvement), number of patients with 2 points (slight to moderate improvement), number of patients with 3 points (unchanged), number ot patients with 4 points (decline) by day 8 according IMOS.
Time Frame
Day 8±1
Title
Number of Cases of Antifebrile Agents Use
Description
Number of cases of the antipyretic product (paracetamol) consumption for the entire study period
Time Frame
Day 8±1
Title
Number of Patients Discontinued From the Study Due to Requirement for Antibacterial Therapy
Description
Number of patients who discontinued from the study due to requirement for antibacterial therapy
Time Frame
Day 8±1
Title
Number of Patients With Normalization of Body Temperature by 5 Day of Treatment
Description
Axillary body temperature level ≤ 36,9 °C confirmed by two consecutive measurements (morning-evening/evening-morning will be considered as normalization of body temperature
Time Frame
Day 5
Title
Number of Patients With Clinical Improvement (Symptom Assessment Scale Total Score ≤ 3) by 5 Day of Treatment
Description
Symptom Assessment Scale (SAS) consists of 3 domains:
Domain "General intoxication symptoms" (altered/increased activity/dysfunctional behavior; altered appetite or food refusal; unhealthy or alter from common appearance; altered or interrupted sleep);
"Nose symptoms" (nasal discharge; nasal congestion; impaired nasal airflow; sneezing);
"Throat and thoracic symptoms" (hoarseness; sore throat; cough). The higher scores mean a worse outcome. The total score is the sum of points of each symptom graded in Symptom Assessment Scale. The maximum possible value of the total score is 30 points, the minimum possible value of the total score is 0 points.
Each symptom may be graded by the following points:
0 points - absent;
1 point - mild;
2 points - moderate;
3 points - severe.
Time Frame
Day 5
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nikolai Dodonov
Organizational Affiliation
NPO Petrovax
Official's Role
Study Chair
Facility Information:
Facility Name
Medical Center "Medical Technology"
City
Saint Petersburg
State/Province
Leningrad Region
ZIP/Postal Code
192148
Country
Russian Federation
Facility Name
Medical Center "MedAestheticCentre Laboratory"
City
Saint Petersburg
State/Province
Leningrad Region
ZIP/Postal Code
192177
Country
Russian Federation
Facility Name
Medical center "Curator"
City
Saint Petersburg
State/Province
Leningrad Region
ZIP/Postal Code
196240
Country
Russian Federation
Facility Name
Children's City Hospital No. 22
City
Saint Petersburg
State/Province
Leningrad Region
ZIP/Postal Code
196657
Country
Russian Federation
Facility Name
Medical center "Korolev Medicine"
City
Naro-Fominsk
State/Province
Moscow Region
ZIP/Postal Code
143300
Country
Russian Federation
Facility Name
City Children's Clinical Clinic №5
City
Perm'
State/Province
Perm Region
ZIP/Postal Code
614066
Country
Russian Federation
Facility Name
Children's City Clinic №4 of the city of Rostov-on-Don
City
Rostov-on-Don
State/Province
Rostov Region
ZIP/Postal Code
344065
Country
Russian Federation
Facility Name
Yaroslavl State Medical University
City
Yaroslavl
State/Province
Yaroslavl Region
ZIP/Postal Code
150000
Country
Russian Federation
Facility Name
Regional Children's Clinical Hospital
City
Yaroslavl
State/Province
Yaroslavl Region
ZIP/Postal Code
150042
Country
Russian Federation
Facility Name
Scientific Clinical Center of Otorhinolaryngology of the Federal Medical and Biological Agency
City
Moscow
ZIP/Postal Code
123182
Country
Russian Federation
Facility Name
Federal state budgetary institution "Research Institute of Influenza" of Ministry of Health of Russia
City
Saint-Petersburg
ZIP/Postal Code
197376
Country
Russian Federation
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
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.
Results Reference
result
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Efficacy and Safety of Polyoxidonium, Nasal and Sublingual Spray, 6 mg/ml in Children Aged 1-12 Years With ARI
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