Back to resultsClinical Trial of Safety and Efficacy of Ergoferon in Liquid Dosage Form in Treatment of Acute Upper Respiratory Tract Infections in Adults
Primary Purpose
Acute Upper Respiratory Tract Infections
Status
Completed
Phase
Phase 3
Locations
Russian Federation
Study Type
Interventional
Intervention
Ergoferon
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Acute Upper Respiratory Tract Infections
Eligibility Criteria
Inclusion Criteria:
- Patients of both genders aged from 18 to 60 years inclusively.
- Patients who visited a doctor during the increase of seasonal incidence within 24 hours after the onset of acute respiratory infection of the upper respiratory tract.
- Body temperature ≥37,8°C at the moment of examination by the doctor.
- Presence of two or more moderate severity symptoms or three or more mild severity symptoms according to the Common Cold Questionnaire (CCQ).
- The possibility to start therapy within 24 hours from the onset of the first symptoms of acute respiratory infection of the upper respiratory tract.
- The use of contraceptive methods by the patients of both the sexes during the study and within 30 days after completion of participation in the study.
- Availability of signed patient information sheet (Informed Consent form) for participation in the clinical trial.
Exclusion Criteria:
- Suspected invasive bacterial infection or the presence of a severe disease requiring use of antibacterial drugs (including sulfanilamides).
- Suspected initial manifestations of diseases that have symptoms similar to acute URTI (other infectious diseases, flu-like symptoms at the onset of systemic connective tissue disorders, hematologic neoplasms and other pathologies).
- Exacerbated or decompensated chronic diseases affecting a patient's ability to participate in the clinical trial.
- Oncological diseases.
- Medical history of polyvalent allergy.
- Allergy/intolerance to any of the components of medications used in the treatment.
- Impaired glucose tolerance, diabetes mellitus type 1 and 2.
- Hereditary fructose intolerance (due to the presence of maltitol in the study drug).
- Use of any medicine listed in the section "Prohibited concomitant treatment" within 30 days preceding the inclusion in this study.
- Pregnancy, breastfeeding.
- Consumption of narcotics, alcohol > 2 alcohol units per day.
- Patients with mental disorders.
- Patients who, from the investigator's point of view, will fail to comply with the observation requirements of the trial or with the regimen of the study drugs.
- Participation in other clinical studies within 3 months prior to enrollment in the current trial.
- Other factors, which hinder the patient's participation in the trial (for example, planned trips or business trips).
- Patients are related to the research staff of the clinical trial site who are directly involved in the trial or are the immediate family member of the researcher. The immediate family members include husband/wife, parents, children or brothers (or sisters), regardless of whether they are natural or adopted.
- Patients employed with MATERIA MEDICA HOLDING (i.e., the company's employee, a part-time employee under contract, or appointed official in charge of the trial, or their immediate family).
Sites / Locations
- Non-governmental Health Care Institution "Road Clinical Hospital at the train station Chelyabinsk of OJSC "Russian Railways"
- State Budgetary Educational Institution of Higher Professional Education "Kazan State Medical University"
- Federal State Budgetary Institution "Scientific Research Institute for Vaccines and Serum named after I.I.Mechnikov" of Russian Academy of Medical Science
- State Budgetary Educational Institution of Higher Professional Education "The Russian National Research Medical University named after N.I. Pirogov"/Outpatient Therapy Department of Medicine Faculty
- State Budgetary Educational Institution of Higher Professional Education "The Russian National Research Medical University named after N.I. Pirogov"
- Federal State Budgetary Institution "Polyclinic № 3" of Affairs Management Department of the President of Russian Federation
- Municipal Health Care Institution "Podolsk city clinical hospital №3"
- Regional State Budgetary Health Care Institution "Policlinic № 6"
- St. Petersburg State Budgetary Health Care Institution " Nevsky Region Сity Polyclinic №25"
- St. Petersburg State Budgetary Health Care Institution "Сity Polyclinic № 117"
- St. Petersburg State Budgetary Health Care Institution "Medical Exercises Dispensary" of Krasnogvardeysky District
- The Non-governmental Health Care Institution "Road Hospital of the Open Joint Stock Company" Russian Railways"
- State Budgetary Educational Institution of Higher Professional Education "St. Petersburg State Medical University named after I.P. Pavlov"
- Federal State Budgetary Health Care Institution Policlinic № 1 of the Russian Academy of Sciences
- St. Petersburg State Budgetary Health Care Institution "Сity Polyclinic № 4"
- State Educational Institution of Higher Professional Education "Voronezh State Medical Academy of N. N. Burdenko" Ministry of Health of the Russian Federation
- State Budgetary Educational Institution of Higher Professional Education "Yaroslavl State Medical Academy"
- State Budgetary Health Care Institution of the Yaroslavl region "Regional Clinical Hospital"
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
Oral use. Dose per administration: 1 dosing spoon (5ml) without food. For best effect, the solution should be held in the mouth before swallowing. Dosing scheme. One dose every 30 minutes for the first 2 hours, followed by three more doses spaced regularly during the rest of the day. From day 2 to 5: 1 spoon taken 3 times daily.
Oral use. Placebo using Ergoferon scheme.
Outcomes
Primary Outcome Measures
Average Duration of Fever.
Primary outcome measure is based on the indicators of tympanic thermometry recorded by the patient in the diary during the period of treatment and observation. Thermometry is performed twice a day (morning and evening).
The criterion of Duration of Fever is the time from enrollment to the first return to the afebrile state or the normalization of tympanic temperature (tympanic temperature ≤37.0 degree Celsius [°C]).
Secondary Outcome Measures
Dynamics of Acute Upper Respiratory Tract Infections (URTI) Symptoms Severity According to the Physical Examination by the Doctor.
Acute URTI symptoms severity is based on the Common Cold Questionnaire (CCQ) and assessed using the "Area under the curve" (AUC) for the total scores on days 1, 3, and 7 of treatment according to the physical examination by the doctor. AUC is calculated by trapezoidal rule. CCQ includes 3 General Symptoms (fevers, chills, muscle pains), 3 Nasal Symptoms (Watery eyes, Runny nose, Sneezing), 1 Throat Symptom (Sore throat), and 2 Chest Symptoms (Cough, Chest pain). Every CCQ symptom is estimated according to the 4-point scoring: none = 0, mild = 1, moderate = 2, severe = 3. Total CCQ scores equal the sum of all scores. The minimum value is 0, and the maximum value is 162. Higher scores mean a worse outcome.
Dynamics of Acute URTI Symptoms Severity According to the Daily Wisconsin Upper Respiratory Symptom Survey - 21 (WURSS-21) Assessment of the Patient (Including the Total WURSS-21 Score, "Symptoms" Domain Score, and "Ability" Domain Score).
Dynamics of symptoms severity according to the WURSS-21 is assessed using the Area under the curve (AUC) for the score for 8 days of the treatment. AUC is calculated by trapezoidal rule. WURSS-21 consists of 21 items (2 questions and 2 domains. Symptoms domain consists of 10 items: Runny nose, Plugged nose, Sneezing, Sore throat, Scratchy throat, Cough, Hoarseness, Head congestion, Chest congestion, Feeling tired. Ability domain consists of 9 items: Think clearly, Sleep well, Breathe easily, Walk, climb stairs, exercise, Accomplish daily activities, Work outside the home, Work inside the home, Interact with others, Live your personal life. The first 20 items are scored according to the 8-point scale (from 0 to 7). The last item is scored according to the 7-point scale: (from 0 to 6). Total WURSS-21 AUC min score=0, max=1169. Symptoms domain min score=0, max=560. Ability domain min score=0, max=504. Higher scores mean a worse outcome.
Percentage of Patients Who Used Antipyretics.
Based on the patient's diary. The outcome is calculated according to the number of patients who were administered the antipyretics due to the fever.
Percentage of Patients Who Have a Worsening of Disease.
The number of patients with the appearance of the lower respiratory tract symptoms, development of complications requiring antibiotics or hospitalization.
Full Information
NCT ID
NCT01765920
First Posted
January 9, 2013
Last Updated
December 10, 2020
Sponsor
Materia Medica Holding
1. Study Identification
Unique Protocol Identification Number
NCT01765920
Brief Title
Clinical Trial of Safety and Efficacy of Ergoferon in Liquid Dosage Form in Treatment of Acute Upper Respiratory Tract Infections in Adults
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 Adult Patients
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
April 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 evaluate safety of the liquid dosage form of Ergoferon in the treatment of acute upper respiratory tract infections in adults;
to evaluate clinical efficacy of the liquid dosage form of Ergoferon in the treatment of acute upper respiratory tract infections in adults.
Detailed Description
Design: multicenter double-blind placebo-controlled parallel-group randomized clinical trial.
The study will enrol outpatient subjects of either gender aged 18-60 years with clinical manifestations of upper respiratory tract infections (URTI) during seasonal morbidity who are presented to the doctor within the first day of the disease onset. Signed information sheet for the patient is obtained from all participants prior to the screening procedures. Medical history, concomitant medication, tympanic thermometry, patient examination by a doctor, assessment of URTI symptoms severity are performed at screening visit.
URTI symptoms severity examination by the physician is based on Common Cold Questionnaire (CCQ) (PLoS One. 2008; 3(3): e1802. Published online 2008 Mar 19. doi: 10.1371/journal.pone.0001802).
If a patient meets the inclusion criteria and does not have any exclusion criteria, at Visit 1 (Day 1), he/she is randomized into one of two groups: the 1st group (Ergoferon group) patients receive Ergoferon according to the scheme for 5 days; the 2nd group (Placebo group) patients receive placebo according to Ergoferon dosage regimen for 5 days.
The patients are provided with a patient diary where they record tympanic temperature (using tympanic thermometer provided by sponsor) twice a day and URTI symptoms severity according to the Wisconsin Upper Respiratory Symptom Survey - 21 - Daily Symptom Report (WURSS-21©, Wisconsin Upper Respiratory Symptom Survey, 2004.
Created by Bruce Barrett MD PhD et al., UW Department of Family Medicine, 777 S. Mills St. Madison, WI 53715, USA).
In addition, antipyretic administration (if applicable), as well as any possible worsening of the patient's condition (if applicable, for Adverse Events (AEs) evaluation), are also be recorded in a patient diary. An investigator provides the instructions on filling out the diary and helps the patient to make first records of URTI symptoms severity and tympanic temperature in the diary.
Patients are observed up for 7 days (screening and randomization for 1 day, study therapy 1-5 days, the follow-up period for 2 days). During treatment and follow-up period two visits are scheduled (at home or at the study site) on days 3 (Visit 2) and day 7 (Visit 3). At Visits 2 and 3, the investigator will carry out a physical examination, record dynamics of URTI symptoms severity (according to CCQ) and concomitant therapy, and check patient diaries. Treatment compliance is evaluated at Visit 3.
During the study, symptomatic therapy and therapy for underlying chronic conditions are allowed with the exception of the drugs indicated in the section "Prohibited Concomitant Treatment".
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
342 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ergoferon (5 ml 3 times a day)
Arm Type
Experimental
Arm Description
Oral use. Dose per administration: 1 dosing spoon (5ml) without food. For best effect, the solution should be held in the mouth before swallowing.
Dosing scheme. One dose every 30 minutes for the first 2 hours, followed by three more doses spaced regularly during the rest of the day. From day 2 to 5: 1 spoon taken 3 times daily.
Arm Title
Placebo (5 ml 3 times a day)
Arm Type
Placebo Comparator
Arm Description
Oral use. Placebo using Ergoferon scheme.
Intervention Type
Drug
Intervention Name(s)
Ergoferon
Intervention Description
5 ml 3 times a day
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
5 ml 3 times a day
Primary Outcome Measure Information:
Title
Average Duration of Fever.
Description
Primary outcome measure is based on the indicators of tympanic thermometry recorded by the patient in the diary during the period of treatment and observation. Thermometry is performed twice a day (morning and evening).
The criterion of Duration of Fever is the time from enrollment to the first return to the afebrile state or the normalization of tympanic temperature (tympanic temperature ≤37.0 degree Celsius [°C]).
Time Frame
1-7 days
Secondary Outcome Measure Information:
Title
Dynamics of Acute Upper Respiratory Tract Infections (URTI) Symptoms Severity According to the Physical Examination by the Doctor.
Description
Acute URTI symptoms severity is based on the Common Cold Questionnaire (CCQ) and assessed using the "Area under the curve" (AUC) for the total scores on days 1, 3, and 7 of treatment according to the physical examination by the doctor. AUC is calculated by trapezoidal rule. CCQ includes 3 General Symptoms (fevers, chills, muscle pains), 3 Nasal Symptoms (Watery eyes, Runny nose, Sneezing), 1 Throat Symptom (Sore throat), and 2 Chest Symptoms (Cough, Chest pain). Every CCQ symptom is estimated according to the 4-point scoring: none = 0, mild = 1, moderate = 2, severe = 3. Total CCQ scores equal the sum of all scores. The minimum value is 0, and the maximum value is 162. Higher scores mean a worse outcome.
Time Frame
Day 1, 3, and 7.
Title
Dynamics of Acute URTI Symptoms Severity According to the Daily Wisconsin Upper Respiratory Symptom Survey - 21 (WURSS-21) Assessment of the Patient (Including the Total WURSS-21 Score, "Symptoms" Domain Score, and "Ability" Domain Score).
Description
Dynamics of symptoms severity according to the WURSS-21 is assessed using the Area under the curve (AUC) for the score for 8 days of the treatment. AUC is calculated by trapezoidal rule. WURSS-21 consists of 21 items (2 questions and 2 domains. Symptoms domain consists of 10 items: Runny nose, Plugged nose, Sneezing, Sore throat, Scratchy throat, Cough, Hoarseness, Head congestion, Chest congestion, Feeling tired. Ability domain consists of 9 items: Think clearly, Sleep well, Breathe easily, Walk, climb stairs, exercise, Accomplish daily activities, Work outside the home, Work inside the home, Interact with others, Live your personal life. The first 20 items are scored according to the 8-point scale (from 0 to 7). The last item is scored according to the 7-point scale: (from 0 to 6). Total WURSS-21 AUC min score=0, max=1169. Symptoms domain min score=0, max=560. Ability domain min score=0, max=504. Higher scores mean a worse outcome.
Time Frame
Days 1 to 8.
Title
Percentage of Patients Who Used Antipyretics.
Description
Based on the patient's diary. The outcome is calculated according to the number of patients who were administered the antipyretics due to the fever.
Time Frame
Days 1, 2, 3, 4, and 5.
Title
Percentage of Patients Who Have a Worsening of Disease.
Description
The number of patients with the appearance of the lower respiratory tract symptoms, development of complications requiring antibiotics or hospitalization.
Time Frame
Days 1, 2, 3, 4.,5, 6, and 7.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients of both genders aged from 18 to 60 years inclusively.
Patients who visited a doctor during the increase of seasonal incidence within 24 hours after the onset of acute respiratory infection of the upper respiratory tract.
Body temperature ≥37,8°C at the moment of examination by the doctor.
Presence of two or more moderate severity symptoms or three or more mild severity symptoms according to the Common Cold Questionnaire (CCQ).
The possibility to start therapy within 24 hours from the onset of the first symptoms of acute respiratory infection of the upper respiratory tract.
The use of contraceptive methods by the patients of both the sexes during the study and within 30 days after completion of participation in the study.
Availability of signed patient information sheet (Informed Consent form) for participation in the clinical trial.
Exclusion Criteria:
Suspected invasive bacterial infection or the presence of a severe disease requiring use of antibacterial drugs (including sulfanilamides).
Suspected initial manifestations of diseases that have symptoms similar to acute URTI (other infectious diseases, flu-like symptoms at the onset of systemic connective tissue disorders, hematologic neoplasms and other pathologies).
Exacerbated or decompensated chronic diseases affecting a patient's ability to participate in the clinical trial.
Oncological diseases.
Medical history of polyvalent allergy.
Allergy/intolerance to any of the components of medications used in the treatment.
Impaired glucose tolerance, diabetes mellitus type 1 and 2.
Hereditary fructose intolerance (due to the presence of maltitol in the study drug).
Use of any medicine listed in the section "Prohibited concomitant treatment" within 30 days preceding the inclusion in this study.
Pregnancy, breastfeeding.
Consumption of narcotics, alcohol > 2 alcohol units per day.
Patients with mental disorders.
Patients who, from the investigator's point of view, will fail to comply with the observation requirements of the trial or with the regimen of the study drugs.
Participation in other clinical studies within 3 months prior to enrollment in the current trial.
Other factors, which hinder the patient's participation in the trial (for example, planned trips or business trips).
Patients are related to the research staff of the clinical trial site who are directly involved in the trial or are the immediate family member of the researcher. The immediate family members include husband/wife, parents, children or brothers (or sisters), regardless of whether they are natural or adopted.
Patients employed with MATERIA MEDICA HOLDING (i.e., the company's employee, a part-time employee under contract, or appointed official in charge of the trial, or their immediate family).
Facility Information:
Facility Name
Non-governmental Health Care Institution "Road Clinical Hospital at the train station Chelyabinsk of OJSC "Russian Railways"
City
Chelyabinsk
ZIP/Postal Code
454091
Country
Russian Federation
Facility Name
State Budgetary Educational Institution of Higher Professional Education "Kazan State Medical University"
City
Kazan
ZIP/Postal Code
420012
Country
Russian Federation
Facility Name
Federal State Budgetary Institution "Scientific Research Institute for Vaccines and Serum named after I.I.Mechnikov" of Russian Academy of Medical Science
City
Moscow
ZIP/Postal Code
105064
Country
Russian Federation
Facility Name
State Budgetary Educational Institution of Higher Professional Education "The Russian National Research Medical University named after N.I. Pirogov"/Outpatient Therapy Department of Medicine Faculty
City
Moscow
ZIP/Postal Code
117997
Country
Russian Federation
Facility Name
State Budgetary Educational Institution of Higher Professional Education "The Russian National Research Medical University named after N.I. Pirogov"
City
Moscow
ZIP/Postal Code
117997
Country
Russian Federation
Facility Name
Federal State Budgetary Institution "Polyclinic № 3" of Affairs Management Department of the President of Russian Federation
City
Moscow
ZIP/Postal Code
129090
Country
Russian Federation
Facility Name
Municipal Health Care Institution "Podolsk city clinical hospital №3"
City
Podolsk
ZIP/Postal Code
142105
Country
Russian Federation
Facility Name
Regional State Budgetary Health Care Institution "Policlinic № 6"
City
Smolensk
ZIP/Postal Code
214000
Country
Russian Federation
Facility Name
St. Petersburg State Budgetary Health Care Institution " Nevsky Region Сity Polyclinic №25"
City
St. Petersburg
ZIP/Postal Code
193312
Country
Russian Federation
Facility Name
St. Petersburg State Budgetary Health Care Institution "Сity Polyclinic № 117"
City
St. Petersburg
ZIP/Postal Code
194358
Country
Russian Federation
Facility Name
St. Petersburg State Budgetary Health Care Institution "Medical Exercises Dispensary" of Krasnogvardeysky District
City
St. Petersburg
ZIP/Postal Code
195112
Country
Russian Federation
Facility Name
The Non-governmental Health Care Institution "Road Hospital of the Open Joint Stock Company" Russian Railways"
City
St. Petersburg
ZIP/Postal Code
19527
Country
Russian Federation
Facility Name
State Budgetary Educational Institution of Higher Professional Education "St. Petersburg State Medical University named after I.P. Pavlov"
City
St. Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
Federal State Budgetary Health Care Institution Policlinic № 1 of the Russian Academy of Sciences
City
St. Petersburg
ZIP/Postal Code
199034
Country
Russian Federation
Facility Name
St. Petersburg State Budgetary Health Care Institution "Сity Polyclinic № 4"
City
St. Petersburg
ZIP/Postal Code
199178
Country
Russian Federation
Facility Name
State Educational Institution of Higher Professional Education "Voronezh State Medical Academy of N. N. Burdenko" Ministry of Health of the Russian Federation
City
Voronezh
ZIP/Postal Code
394036
Country
Russian Federation
Facility Name
State Budgetary Educational Institution of Higher Professional Education "Yaroslavl State Medical Academy"
City
Yaroslavl
ZIP/Postal Code
150000
Country
Russian Federation
Facility Name
State Budgetary Health Care Institution of the Yaroslavl region "Regional Clinical Hospital"
City
Yaroslavl
ZIP/Postal Code
150062
Country
Russian Federation
12. IPD Sharing Statement
Learn more about this trial
Clinical Trial of Safety and Efficacy of Ergoferon in Liquid Dosage Form in Treatment of Acute Upper Respiratory Tract Infections in Adults
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