Clinical Trial of Safety and Efficacy of Ergoferon in Liquid Dosage Form in Treatment of Acute Upper Respiratory Tract Infections in Adults
Condition: Acute Upper Respiratory Tract Infections
MeSH terms: Infections; Communicable Diseases; Respiratory Tract Infections
Study type: Interventional
Phase: Phase 3

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".
    

Intervention name(s): Ergoferon; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 5 ml 3 times a day; 5 ml 3 times a day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment