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Acute Respiratory InfectionPhase 3NCT03840135

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

A Phase 3 study testing Polyoxidonium 6 mg/ml in people with Acute Respiratory Infection, run by NPO Petrovax at 11 sites in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 1 year to 12 years
Conditions the study is for
Acute Respiratory Infection
What is being tested?
Polyoxidonium 6 mg/ml
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
172 participants
Where
11 sitesRussia
Study dates
7 Nov 2018to 10 Dec 2019
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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)

Who cannot join

  • 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.
Show all 14Show fewer
  • 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.

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

Russia11 sites

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

    Moscow, 123182

  • Medical center "Korolev Medicine"

    Naro-Fominsk, Moscow Oblast, 143300

  • City Children's Clinical Clinic №5

    Perm, Perm Krai, 614066

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

    Rostov-on-Don, Rostov Oblast, 344065

  • Medical Center "Medical Technology"

    Saint Petersburg, Leningradskaya Oblast', 192148

  • Medical Center "MedAestheticCentre Laboratory"

    Saint Petersburg, Leningradskaya Oblast', 192177

  • Medical center "Curator"

    Saint Petersburg, Leningradskaya Oblast', 196240

  • Children's City Hospital No. 22

    Saint Petersburg, Leningradskaya Oblast', 196657

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

    Saint Petersburg, 197376

  • Yaroslavl State Medical University

    Yaroslavl, Yaroslavl Oblast, 150000

  • Regional Children's Clinical Hospital

    Yaroslavl, Yaroslavl Oblast, 150042

Other trials in Russia

About this study

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)

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.

Read the 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.

Being tested
Polyoxidonium 6 mg/ml, Placebo
Keywords
ARI, acute respiratory infection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Polyoxidonium 6 mg/mlDrug

    Also called Polyoxidonium, Nasal and Sublingual Spray, 6 mg/ml

    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).

  • PlaceboOther

    Also called Placebo, Nasal and Sublingual Spray

    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).

Study groups in NCT03840135
Study groupRoleWhat they receive
Polyoxidonium 6 mg/mlExperimentalPolyoxidonium 6 mg/ml nasal and sublingual spray - 0,15 mg/kg daily - 7 days.
Receives: Drug: Polyoxidonium 6 mg/ml
PlaceboPlacebo comparatorPlacebo, nasal and sublingual spray - 7 days.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Day 8±1

Secondary outcomes (10)

  1. 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.

    Measured: Day 3

  2. 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)

    Measured: Day 3, Day 5

  3. 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.

    Measured: Day 3, Day 5

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

    Symptom Assessment Scale (SAS) consists of 3 domains:

    1. Domain "General intoxication symptoms" (altered/increased activity/dysfunctional behavior; altered appetite or food refusal; unhealthy or alter from common appearance; altered or interrupted sleep);
    2. "Nose symptoms" (nasal discharge; nasal congestion/impaired nasal airflow; sneezing);
    3. "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.

    Measured: Day 3, Day 5

  5. 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;

    1. point - significant improvement;
    2. points - slight to moderate improvement;
    3. points - unchanged;
    4. 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.

    Measured: Day 8±1

  6. 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;

    1. point - significant improvement;
    2. points - slight to moderate improvement;
    3. points - unchanged;
    4. 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.

    Measured: Day 8±1

  7. Number of Cases of Antifebrile Agents Use

    Number of cases of the antipyretic product (paracetamol) consumption for the entire study period

    Measured: Day 8±1

  8. 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

    Measured: Day 8±1

  9. 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

    Measured: Day 5

  10. 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:

    1. Domain "General intoxication symptoms" (altered/increased activity/dysfunctional behavior; altered appetite or food refusal; unhealthy or alter from common appearance; altered or interrupted sleep);
    2. "Nose symptoms" (nasal discharge; nasal congestion; impaired nasal airflow; sneezing);
    3. "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.

    Measured: Day 5

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Feb 2019
  2. Study start7 Nov 2018
  3. Primary completion26 Feb 2019
  4. Study completion10 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
172 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03840135
Sponsor's protocol ID
PoArvi/PhIII_2017
Status last verified
Jul 2020
First submitted
26 Nov 2018
Last updated
29 Jul 2020
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Polyoxidonium 6 mg/ml in people with Acute Respiratory Infection, run by NPO Petrovax at 11 sites in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fever Duration (With a Superiority Cut-off Level δ=-0,52 Days) (time frame: Day 8±1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03840135, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2020.

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