Acute Upper Respiratory Tract InfectionsPhase 3NCT01765920
Clinical Trial of Safety and Efficacy of Ergoferon in Liquid Dosage Form in Treatment of Acute Upper Respiratory Tract Infections in Adults
A Phase 3 study testing Ergoferon in people with Acute Upper Respiratory Tract Infections, run by Materia Medica Holding at 18 sites in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Acute Upper Respiratory Tract Infections
- What is being tested?
- Ergoferon
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 342 participants
- Where
- 18 sitesRussia
- Study dates
- Dec 2012to Apr 2015
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 17Show fewer
- 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).
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
Russia18 sites
Non-governmental Health Care Institution "Road Clinical Hospital at the train station Chelyabinsk of OJSC "Russian Railways"
Chelyabinsk, 454091
State Budgetary Educational Institution of Higher Professional Education "Kazan State Medical University"
Kazan', 420012
Federal State Budgetary Institution "Scientific Research Institute for Vaccines and Serum named after I.I.Mechnikov" of Russian Academy of Medical Science
Moscow, 105064
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
Moscow, 117997
State Budgetary Educational Institution of Higher Professional Education "The Russian National Research Medical University named after N.I. Pirogov"
Moscow, 117997
Federal State Budgetary Institution "Polyclinic № 3" of Affairs Management Department of the President of Russian Federation
Moscow, 129090
Municipal Health Care Institution "Podolsk city clinical hospital №3"
Podolsk, 142105
St. Petersburg State Budgetary Health Care Institution " Nevsky Region Сity Polyclinic №25"
Saint Petersburg, 193312
St. Petersburg State Budgetary Health Care Institution "Сity Polyclinic № 117"
Saint Petersburg, 194358
St. Petersburg State Budgetary Health Care Institution "Medical Exercises Dispensary" of Krasnogvardeysky District
Saint Petersburg, 195112
The Non-governmental Health Care Institution "Road Hospital of the Open Joint Stock Company" Russian Railways"
Saint Petersburg, 19527
State Budgetary Educational Institution of Higher Professional Education "St. Petersburg State Medical University named after I.P. Pavlov"
Saint Petersburg, 197022
Federal State Budgetary Health Care Institution Policlinic № 1 of the Russian Academy of Sciences
Saint Petersburg, 199034
St. Petersburg State Budgetary Health Care Institution "Сity Polyclinic № 4"
Saint Petersburg, 199178
Regional State Budgetary Health Care Institution "Policlinic № 6"
Smolensk, 214000
State Educational Institution of Higher Professional Education "Voronezh State Medical Academy of N. N. Burdenko" Ministry of Health of the Russian Federation
Voronezh, 394036
State Budgetary Educational Institution of Higher Professional Education "Yaroslavl State Medical Academy"
Yaroslavl, 150000
State Budgetary Health Care Institution of the Yaroslavl region "Regional Clinical Hospital"
Yaroslavl, 150062
About this study
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
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.
Read the 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".
- Conditions
- Acute Upper Respiratory Tract Infections
- Being tested
- Ergoferon, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErgoferonDrug
5 ml 3 times a day
PlaceboDrug
5 ml 3 times a day
| Study group | Role | What they receive |
|---|---|---|
| Ergoferon (5 ml 3 times a day) | Experimental | 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. Receives: Drug: Ergoferon |
| Placebo (5 ml 3 times a day) | Placebo comparator | Oral use. Placebo using Ergoferon scheme. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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]).
Measured: 1-7 days
Secondary outcomes (4)
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.
Measured: Day 1, 3, and 7.
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.
Measured: Days 1 to 8.
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.
Measured: Days 1, 2, 3, 4, and 5.
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.
Measured: Days 1, 2, 3, 4.,5, 6, and 7.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2013 (estimated)
- Study startDec 2012
- Primary completionDec 2014
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute Upper Respiratory Tract InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 342 participants (actual)
Sponsor and investigators
- Lead sponsor
- Materia Medica Holding
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01765920
- Sponsor's protocol ID
- MMH-ER-006
- Status last verified
- Jan 2019
- First submitted
- 9 Jan 2013
- Last updated
- 5 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01765920
- Acronym / sponsor ID
- MMH-ER-006
- Conditions
- Acute Upper Respiratory Tract Infections
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 342 participants (actual)
- Lead sponsor
- Materia Medica HoldingIndustry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 10 Jan 2013 (estimated)
- Results
- Posted 11 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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".
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ergoferon (5 ml 3 times a day) | Experimental | Drug: ErgoferonOral 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. |
| Placebo (5 ml 3 times a day) | Placebo comparator | Drug: PlaceboOral use. Placebo using Ergoferon scheme. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ergoferon5 ml 3 times a day | Drug | Ergoferon (5 ml 3 times a day) |
| Placebo5 ml 3 times a day | Drug | Placebo (5 ml 3 times a day) |
Primary outcome
Average Duration of Fever.
Time frame: 1-7 days
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]).
4 secondary outcomes
Dynamics of Acute Upper Respiratory Tract Infections (URTI) Symptoms Severity According to the Physical Examination by the Doctor.
Time frame: Day 1, 3, and 7.
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).
Time frame: Days 1 to 8.
Percentage of Patients Who Used Antipyretics.
Time frame: Days 1, 2, 3, 4, and 5.
Percentage of Patients Who Have a Worsening of Disease.
Time frame: Days 1, 2, 3, 4.,5, 6, and 7.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ergoferon in people with Acute Upper Respiratory Tract Infections, run by Materia Medica Holding at 18 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 7 inclusion and 17 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 5 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 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 11 Dec 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?
Average Duration of Fever. (time frame: 1-7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jan 2021.