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Clinical Trial of Safety and Clinical Efficacy of Ergoferon in Liquid Dosage Form in Treatment of Acute Upper Respiratory Tract Infections in Children

Primary Purpose

Acute Upper Respiratory Tract Infections

Status
Completed
Phase
Phase 3
Locations
Russian Federation
Study Type
Interventional
Intervention
Ergoferon
Placebo
Sponsored by
Materia Medica Holding
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Upper Respiratory Tract Infections

Eligibility Criteria

3 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients of both sexes aged over 3 years and under 18 years.
  2. Patients who consulted a doctor within 24 hours after the onset of acute respiratory infection (body temperature no less than 38.0°C when visiting a doctor + intensity of symptoms ≥ 4 scores (presence of at least 1 general symptom ≥ 2 scores and 1 nasal/ throat/ chest symptom ≥ 2 scores or greater number of symptoms with the intensity≥1 score) during seasonal morbidity.
  3. The possibility to start therapy within 24 hours after the onset of the first symptoms of acute respiratory infection.
  4. Usage of contraceptive methods by sexually active teenagers of both sexes during the trial and within 30 days after ending of the participation in the trial.
  5. Availability of information sheet (Informed Consent form) for parents/adopters of patient for participation in the clinical trial, Version 2.1 or Version 2.2, signed by one parent/adopter of patient. For patients over 14 years - availability of information sheet (Informed Consent form) for participation in the clinical trial, Version 2.1 or Version 2.2, signed by a patient and one parent/adopter of patient.

Exclusion Criteria:

  1. Suspected bacterial infection or presence of a severe disease requiring use of antibacterial drugs (including sulfanilamides).
  2. Suspected initial manifestations of diseases that have symptoms similar to acute respiratory infection (other infectious diseases, influenza-like syndrome at the onset of systemic connective tissue disorders, oncohematology and other pathology).
  3. Medical history of primary and secondary immune deficiency: a) lymphoid system immunodeficiency (T-cell and /or B-cell immunity chain, immunodeficiency with predominant antibody deficiency); b) phagocyte deficiency; c) complement factors deficiency; d ) combined immunodeficiency including AIDS induced by HIV infection; toxic, autoimmune, infectious, radial panleukopenia syndrome; general lymphocytopenia syndrome; syndrome of lymphocyte polyclonal activation; postsplenectomia syndrome; congenital asplenia; syndrome of immune complexes pathology associated with infectious, allergic and autoimmune diseases.
  4. Medical history of sarcoidosis.
  5. Oncological diseases.
  6. Exacebration or decompensation of chronic diseases affecting the patient's ability to participate in the clinical trial.
  7. Medical history of polyvalent allergy.
  8. Allergy/ intolerance to any of the components of medications used in the treatment.
  9. Impaired glucose tolerance, diabetes mellitus.
  10. Hereditary fructose intolerance (as the study drug contains maltitol).
  11. Intake of medicines listed in the section "Prohibited concomitant treatment" for 1 month prior to the inclusion in the trial.
  12. Pregnancy, unwillingness of sexually active female patients to use of contraceptive methods during the study.
  13. Drug addiction, alcohol usage in the amount 2 units of alcohol per day on the part of patient's parents/adopters.
  14. Mental disorders of patient or of patient's parents/adopters.
  15. Patient's parents/ adopters, who from investigator's point of view, will fail to comply with the observation requirements of the trial or with the intake regimen of the investigated medicines.
  16. Participation in other clinical trials in the course of 3 months prior to the inclusion in the trial.
  17. Patient's parent/adopter is related to the research personnel of the investigative site, who are directly involved in the trial or are the immediate relative of the researcher. The immediate relatives includes husband/wife, parents, children or brothers (or sisters), regardless of whether they are natural or adopted.
  18. Patient's parent/adopter works for OOO "NPF "Materia Medica Holding" (i.e. is the company's employee, temporary contract worker or appointed official responsible for the carrying out the research) or the immediate relative.

Sites / Locations

  • Municipal Institution "Child Health City Hospital №11"
  • State Educational Institution of Higher Professional Education "Moscow State Medical Academy named after I.M. Sechenov"
  • State Budgetary Educational Institution of Higher Professional Education Novosibirsk State Medical University of Ministry of Health of Russian Federation
  • Municipal Health Care Institution "City Child Health Clinical Polyclinic №5"
  • St. Peterburg State Health Care Institution "Child Health City Hospital №45 of the Nevsky Region"
  • State Budgetary Health Care Institution "Сity Child Health Polyclinic №44"
  • St. Petersburg State Budgetary Health Care Institution "Сity Polyclinic №44"
  • State Budgetary Educational Institution of Higher Professional Education "St. Petersburg State Pediatric Medical Academy" of Ministry of Health of Russian Federation
  • State Health Care Institution "Child Health City Hospital №22"
  • Limited Liability Company "Alliance Biomedical-Russian group"
  • State Budgetary Educational Institution of Higher Professional Education " Yaroslavl State Medical Academy" of Ministry of Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ergoferon (5 ml 3 times a day)

Placebo (5 ml 3 times a day)

Arm Description

Outcomes

Primary Outcome Measures

Percentage of Patients With Recovery/Improvement in Health on Days 2, 3 and 4 of Observation (Based on Patient Diary Data)
Based on the data mentioned in a patient's diary

Secondary Outcome Measures

Dynamics of Fever (Changes in Body Temperature on 2, 3, 4, 5 Days of Observation in Comparison With the Baseline)
Percentage of Patients With Normal Body Temperature (≤37.0ºС)
Axillary temperature (morning and evening) decline to or below 37.0 ºС
Severity of Clinical Manifestations of Acute Respiratory Infection (ARI) by Total Symptom Score on Day 3 of Observation (Based on the Results of Pediatrician's Examination) and on Days 2, 3, 4 and 5 of Observation (Based on Patient Diary Data)
The Total Symptom Score (TSS) was based on the severity of each of acute respiratory infection (ARI) symptom. The TSS includes 13 symptoms: Body temperature / fever, Non-specific ARI symptoms (headache, chills, sweating, weakness, muscle pain, drowsiness), Nasal/Throat/Chest symptoms (Runny nose, Nasal congestion, Sneezing, Sore throat, Hoarseness, Cough, Chest pain/Tightness of the chest). The severity of Non-specific and Nasal/Throat/Chest symptom was scored on a symptom severity scale (0 = no symptoms; 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms). The Fever was scored on a symptom severity scale 0 = no symptom (≤37,30С); 1 = mild symptom (37,4-38,00С); 2 = moderate symptom (38,1-39,00); 3 = severe symptom (≥39,10С). Minimum score=0; maximum score=39. The severity of ARI symptoms was recorded: 1) by the doctors on the case record form on Day 3; 2) by one of the patient's parents/adopter on a diary card twice a day (morning and evening) on Days 2-5.
Duration of Acute Respiratory Infection Symptoms (Fever, Non-specific Symptoms and Nasal/ Throat/ Chest Symptoms) Based on Patient Diary Data
Acute respiratory infection (ARI) symptoms include 13 symptoms: Body temperature / fever, Non-specific ARI symptoms (headache, chills, sweating, weakness, muscle pain, drowsiness), Nasal/Throat/Chest symptoms (Runny nose, Nasal congestion, Sneezing, Sore throat, Hoarseness, Cough, Chest pain/Tightness of the chest). The ARI symptoms was recorded by one of the patient's parents/adopter on a diary card twice a day (morning and evening) on Days 1-5.
Severity of the Disease Within 6 Days Was Assessed Using the "Area Under the Curve" for the Total Symptom Score (TSS)
The Total Symptom Score (TSS) was based on the severity of each of acute respiratory infection (ARI) symptom. The TSS includes 13 symptoms: Body temperature / fever, Non-specific ARI symptoms (headache, chills, sweating, weakness, muscle pain, drowsiness), Nasal/Throat/Chest symptoms (Runny nose, Nasal congestion, Sneezing, Sore throat, Hoarseness, Cough, Chest pain/Tightness of the chest). The severity of Non-specific and Nasal/Throat/Chest symptom was scored on a symptom severity scale (0 = no symptoms; 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms). The Fever was scored on a symptom severity scale 0 = no symptom (≤37,30С); 1 = mild symptom (37,4-38,00С); 2 = moderate symptom (38,1-39,00); 3 = severe symptom (≥39,10С). Minimum score=0; maximum score=39. The severity of ARI symptoms was recorded: 1) by the doctors on the case record form on Days 1, 3, 6; 2) by one of the patient's parents/adopter on a diary card twice a day (morning and evening) on Days 1-5.
Number of Intakes of Antipyretics if Indicated
Based on data mentioned in a patient's diary
Percentage of Patients With Exacerbation of the Disease Course
The development of disease complications requiring antibiotics administration or hospitalization

Full Information

First Posted
April 26, 2013
Last Updated
November 28, 2018
Sponsor
Materia Medica Holding
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1. Study Identification

Unique Protocol Identification Number
NCT01843842
Brief Title
Clinical Trial of Safety and Clinical Efficacy of Ergoferon in Liquid Dosage Form in Treatment of Acute Upper Respiratory Tract Infections in Children
Official Title
Multicentre Double-blind Placebo-controlled Parallel-group Randomized Clinical Trial of Safety and Clinical Efficacy of Ergoferon in Liquid Dosage Form in Treatment of Acute Upper Respiratory Tract Infections in Children
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Materia Medica Holding

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is: to assess safety of the liquid dosage form of Ergoferon for treatment of acute upper respiratory tract infections in children; to assess clinical efficacy of the liquid dosage form of Ergoferon for treatment acute upper respiratory tract infections in children.
Detailed Description
The overall duration of a patient's participation in the trial is 6 days (screening/randomization, therapy onset - day 1; study therapy period - 5 days; follow-up period-1 day).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Upper Respiratory Tract Infections

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
306 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ergoferon (5 ml 3 times a day)
Arm Type
Experimental
Arm Title
Placebo (5 ml 3 times a day)
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Ergoferon
Intervention Description
Safety and Efficiency of liquid dosage form
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Safety and Efficiency of liquid dosage form
Primary Outcome Measure Information:
Title
Percentage of Patients With Recovery/Improvement in Health on Days 2, 3 and 4 of Observation (Based on Patient Diary Data)
Description
Based on the data mentioned in a patient's diary
Time Frame
On day 2, 3 and 4 of observation
Secondary Outcome Measure Information:
Title
Dynamics of Fever (Changes in Body Temperature on 2, 3, 4, 5 Days of Observation in Comparison With the Baseline)
Time Frame
baseline and days 2, 3, 4 and 5 of observation
Title
Percentage of Patients With Normal Body Temperature (≤37.0ºС)
Description
Axillary temperature (morning and evening) decline to or below 37.0 ºС
Time Frame
On day 2, 3, 4, 5 of observation
Title
Severity of Clinical Manifestations of Acute Respiratory Infection (ARI) by Total Symptom Score on Day 3 of Observation (Based on the Results of Pediatrician's Examination) and on Days 2, 3, 4 and 5 of Observation (Based on Patient Diary Data)
Description
The Total Symptom Score (TSS) was based on the severity of each of acute respiratory infection (ARI) symptom. The TSS includes 13 symptoms: Body temperature / fever, Non-specific ARI symptoms (headache, chills, sweating, weakness, muscle pain, drowsiness), Nasal/Throat/Chest symptoms (Runny nose, Nasal congestion, Sneezing, Sore throat, Hoarseness, Cough, Chest pain/Tightness of the chest). The severity of Non-specific and Nasal/Throat/Chest symptom was scored on a symptom severity scale (0 = no symptoms; 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms). The Fever was scored on a symptom severity scale 0 = no symptom (≤37,30С); 1 = mild symptom (37,4-38,00С); 2 = moderate symptom (38,1-39,00); 3 = severe symptom (≥39,10С). Minimum score=0; maximum score=39. The severity of ARI symptoms was recorded: 1) by the doctors on the case record form on Day 3; 2) by one of the patient's parents/adopter on a diary card twice a day (morning and evening) on Days 2-5.
Time Frame
on Days 2, 3, 4, 5 of Observation
Title
Duration of Acute Respiratory Infection Symptoms (Fever, Non-specific Symptoms and Nasal/ Throat/ Chest Symptoms) Based on Patient Diary Data
Description
Acute respiratory infection (ARI) symptoms include 13 symptoms: Body temperature / fever, Non-specific ARI symptoms (headache, chills, sweating, weakness, muscle pain, drowsiness), Nasal/Throat/Chest symptoms (Runny nose, Nasal congestion, Sneezing, Sore throat, Hoarseness, Cough, Chest pain/Tightness of the chest). The ARI symptoms was recorded by one of the patient's parents/adopter on a diary card twice a day (morning and evening) on Days 1-5.
Time Frame
baseline and days 2, 3, 4 and 5 of observation
Title
Severity of the Disease Within 6 Days Was Assessed Using the "Area Under the Curve" for the Total Symptom Score (TSS)
Description
The Total Symptom Score (TSS) was based on the severity of each of acute respiratory infection (ARI) symptom. The TSS includes 13 symptoms: Body temperature / fever, Non-specific ARI symptoms (headache, chills, sweating, weakness, muscle pain, drowsiness), Nasal/Throat/Chest symptoms (Runny nose, Nasal congestion, Sneezing, Sore throat, Hoarseness, Cough, Chest pain/Tightness of the chest). The severity of Non-specific and Nasal/Throat/Chest symptom was scored on a symptom severity scale (0 = no symptoms; 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms). The Fever was scored on a symptom severity scale 0 = no symptom (≤37,30С); 1 = mild symptom (37,4-38,00С); 2 = moderate symptom (38,1-39,00); 3 = severe symptom (≥39,10С). Minimum score=0; maximum score=39. The severity of ARI symptoms was recorded: 1) by the doctors on the case record form on Days 1, 3, 6; 2) by one of the patient's parents/adopter on a diary card twice a day (morning and evening) on Days 1-5.
Time Frame
On days 1-6 of observation
Title
Number of Intakes of Antipyretics if Indicated
Description
Based on data mentioned in a patient's diary
Time Frame
On day 1, 2, 3, 4 and 5 of the treatment
Title
Percentage of Patients With Exacerbation of the Disease Course
Description
The development of disease complications requiring antibiotics administration or hospitalization
Time Frame
On days 1-6 of observation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients of both sexes aged over 3 years and under 18 years. Patients who consulted a doctor within 24 hours after the onset of acute respiratory infection (body temperature no less than 38.0°C when visiting a doctor + intensity of symptoms ≥ 4 scores (presence of at least 1 general symptom ≥ 2 scores and 1 nasal/ throat/ chest symptom ≥ 2 scores or greater number of symptoms with the intensity≥1 score) during seasonal morbidity. The possibility to start therapy within 24 hours after the onset of the first symptoms of acute respiratory infection. Usage of contraceptive methods by sexually active teenagers of both sexes during the trial and within 30 days after ending of the participation in the trial. Availability of information sheet (Informed Consent form) for parents/adopters of patient for participation in the clinical trial, Version 2.1 or Version 2.2, signed by one parent/adopter of patient. For patients over 14 years - availability of information sheet (Informed Consent form) for participation in the clinical trial, Version 2.1 or Version 2.2, signed by a patient and one parent/adopter of patient. Exclusion Criteria: Suspected bacterial infection or presence of a severe disease requiring use of antibacterial drugs (including sulfanilamides). Suspected initial manifestations of diseases that have symptoms similar to acute respiratory infection (other infectious diseases, influenza-like syndrome at the onset of systemic connective tissue disorders, oncohematology and other pathology). Medical history of primary and secondary immune deficiency: a) lymphoid system immunodeficiency (T-cell and /or B-cell immunity chain, immunodeficiency with predominant antibody deficiency); b) phagocyte deficiency; c) complement factors deficiency; d ) combined immunodeficiency including AIDS induced by HIV infection; toxic, autoimmune, infectious, radial panleukopenia syndrome; general lymphocytopenia syndrome; syndrome of lymphocyte polyclonal activation; postsplenectomia syndrome; congenital asplenia; syndrome of immune complexes pathology associated with infectious, allergic and autoimmune diseases. Medical history of sarcoidosis. Oncological diseases. Exacebration or decompensation of chronic diseases affecting the patient's ability to participate in the clinical trial. Medical history of polyvalent allergy. Allergy/ intolerance to any of the components of medications used in the treatment. Impaired glucose tolerance, diabetes mellitus. Hereditary fructose intolerance (as the study drug contains maltitol). Intake of medicines listed in the section "Prohibited concomitant treatment" for 1 month prior to the inclusion in the trial. Pregnancy, unwillingness of sexually active female patients to use of contraceptive methods during the study. Drug addiction, alcohol usage in the amount 2 units of alcohol per day on the part of patient's parents/adopters. Mental disorders of patient or of patient's parents/adopters. Patient's parents/ adopters, who from investigator's point of view, will fail to comply with the observation requirements of the trial or with the intake regimen of the investigated medicines. Participation in other clinical trials in the course of 3 months prior to the inclusion in the trial. Patient's parent/adopter is related to the research personnel of the investigative site, who are directly involved in the trial or are the immediate relative of the researcher. The immediate relatives includes husband/wife, parents, children or brothers (or sisters), regardless of whether they are natural or adopted. Patient's parent/adopter works for OOO "NPF "Materia Medica Holding" (i.e. is the company's employee, temporary contract worker or appointed official responsible for the carrying out the research) or the immediate relative.
Facility Information:
Facility Name
Municipal Institution "Child Health City Hospital №11"
City
Ekaterinburg
ZIP/Postal Code
620028
Country
Russian Federation
Facility Name
State Educational Institution of Higher Professional Education "Moscow State Medical Academy named after I.M. Sechenov"
City
Moscow
ZIP/Postal Code
119992
Country
Russian Federation
Facility Name
State Budgetary Educational Institution of Higher Professional Education Novosibirsk State Medical University of Ministry of Health of Russian Federation
City
Novosibirsk
ZIP/Postal Code
630091
Country
Russian Federation
Facility Name
Municipal Health Care Institution "City Child Health Clinical Polyclinic №5"
City
Perm
ZIP/Postal Code
614066
Country
Russian Federation
Facility Name
St. Peterburg State Health Care Institution "Child Health City Hospital №45 of the Nevsky Region"
City
St. Peterburg
ZIP/Postal Code
193312
Country
Russian Federation
Facility Name
State Budgetary Health Care Institution "Сity Child Health Polyclinic №44"
City
St. Petersburg
ZIP/Postal Code
191144
Country
Russian Federation
Facility Name
St. Petersburg State Budgetary Health Care Institution "Сity Polyclinic №44"
City
St. Petersburg
ZIP/Postal Code
192212
Country
Russian Federation
Facility Name
State Budgetary Educational Institution of Higher Professional Education "St. Petersburg State Pediatric Medical Academy" of Ministry of Health of Russian Federation
City
St. Petersburg
ZIP/Postal Code
194100
Country
Russian Federation
Facility Name
State Health Care Institution "Child Health City Hospital №22"
City
St. Petersburg
ZIP/Postal Code
196650
Country
Russian Federation
Facility Name
Limited Liability Company "Alliance Biomedical-Russian group"
City
St.Petersburg
ZIP/Postal Code
194356
Country
Russian Federation
Facility Name
State Budgetary Educational Institution of Higher Professional Education " Yaroslavl State Medical Academy" of Ministry of Health
City
Yaroslavl
ZIP/Postal Code
150000
Country
Russian Federation

12. IPD Sharing Statement

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Clinical Trial of Safety and Clinical Efficacy of Ergoferon in Liquid Dosage Form in Treatment of Acute Upper Respiratory Tract Infections in Children

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