Clinical trial NCT01765920: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Upper Respiratory Tract Infections
Lead sponsor: Materia Medica Holding
Sponsor class: INDUSTRY
First posted: 2013-01-10
Enrollment: 342
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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".

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).

Primary outcomes:
measure: Average Duration of Fever.
timeFrame: 1-7 days
Secondary outcomes:
measure: Dynamics of Acute Upper Respiratory Tract Infections (URTI) Symptoms Severity According to the Physical Examination by the Doctor.
timeFrame: Day 1, 3, and 7.
measure: 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).
timeFrame: Days 1 to 8.
measure: Percentage of Patients Who Used Antipyretics.
timeFrame: Days 1, 2, 3, 4, and 5.
measure: Percentage of Patients Who Have a Worsening of Disease.
timeFrame: Days 1, 2, 3, 4.,5, 6, and 7.
Other outcomes:
Locations:
city: Chelyabinsk
country: Russian Federation
facility: Non-governmental Health Care Institution "Road Clinical Hospital at the train station Chelyabinsk of OJSC "Russian Railways"
city: Kazan
country: Russian Federation
facility: State Budgetary Educational Institution of Higher Professional Education "Kazan State Medical University"
city: Moscow
country: Russian Federation
facility: Federal State Budgetary Institution "Scientific Research Institute for Vaccines and Serum named after I.I.Mechnikov" of Russian Academy of Medical Science
city: Moscow
country: Russian Federation
facility: 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
country: Russian Federation
facility: State Budgetary Educational Institution of Higher Professional Education "The Russian National Research Medical University named after N.I. Pirogov"
city: Moscow
country: Russian Federation
facility: Federal State Budgetary Institution "Polyclinic № 3" of Affairs Management Department of the President of Russian Federation
city: Podolsk
country: Russian Federation
facility: Municipal Health Care Institution "Podolsk city clinical hospital №3"
city: Smolensk
country: Russian Federation
facility: Regional State Budgetary Health Care Institution "Policlinic № 6"
city: St. Petersburg
country: Russian Federation
facility: St. Petersburg State Budgetary Health Care Institution " Nevsky Region Сity Polyclinic №25"
city: St. Petersburg
country: Russian Federation
facility: St. Petersburg State Budgetary Health Care Institution "Сity Polyclinic № 117"
city: St. Petersburg
country: Russian Federation
facility: St. Petersburg State Budgetary Health Care Institution "Medical Exercises Dispensary" of Krasnogvardeysky District
city: St. Petersburg
country: Russian Federation
facility: The Non-governmental Health Care Institution "Road Hospital of the Open Joint Stock Company" Russian Railways"
city: St. Petersburg
country: Russian Federation
facility: State Budgetary Educational Institution of Higher Professional Education "St. Petersburg State Medical University named after I.P. Pavlov"
city: St. Petersburg
country: Russian Federation
facility: Federal State Budgetary Health Care Institution Policlinic № 1 of the Russian Academy of Sciences
city: St. Petersburg
country: Russian Federation
facility: St. Petersburg State Budgetary Health Care Institution "Сity Polyclinic № 4"
city: Voronezh
country: Russian Federation
facility: State Educational Institution of Higher Professional Education "Voronezh State Medical Academy of N. N. Burdenko" Ministry of Health of the Russian Federation
city: Yaroslavl
country: Russian Federation
facility: State Budgetary Educational Institution of Higher Professional Education "Yaroslavl State Medical Academy"
city: Yaroslavl
country: Russian Federation
facility: State Budgetary Health Care Institution of the Yaroslavl region "Regional Clinical Hospital"
Study officials:
References: