Reducing illness duration of acute upper respiratory tract infections Respiratory
Conditions
Interventions
Study 1 (18 to 60 years old): Aviron Rapid or Placebo giving orally as follows: Day I: 3x3 tbl
Day II: 3x2 tbl
Day III: 3x1 tbl
Day IV: 3x1 tbl
Day V: 3x1 tbl
Study 2 (13 to 17 years old): Aviron Rapid or Placebo giving orally as follows: Day I: 3x3 tbl
Day V: 3x1 tbl
Study 3 (5 to 12 years old): Aviron Rapid or Placebo giving orally as follows: Day I: 3x2 tbl
Day II: 3x1 tbl
Day V: 3x1 tbl
Day VI: 3x1 tbl
Day VII: 3x1 tbl
In study 1 and study 2, the participants are to be followed up twice daily for 5 days
in study 3 the participants are to be followed up twice daily for 7 days.
To ensure randomization, every package will have a unique number generated by randomization software. The pati
Sponsors
Neopharm Bulgatia Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Both male and female patients, at the age of 18-60 years, including for study 1; 13-17 years, including for study 2; and 5-12 years, including for study 3 2. Diagnosis Acute upper respiratory tract viral infection in terms of axillary temperature >37.0°C at the moment of examination, and at least one of the symptoms: nasal congestion, sore throat, cough, headache, fatigue/easy fatigue, sleep disturbances 3. First symptom presented in previous 24 hours to GP visit 4. Patient's Informed Consent for study participation signed by the patient in study 1, or by one parent/guardian in study 2 and study 3.
Exclusion criteria
Exclusion criteria: 1. Inosine acedoben dimepranol, Rimantadine hydrochloride intake. 2. Patients prescribed ?seltamivir, zanamivir. 3. Presumed pneumonia, bacterial infection, or severe disease requiring antibacterial agents beginning on the first day of disease. 4. Inclusion of antibiotic in therapy during the study. 5. Clinical symptoms of severe influenza/acute upper respiratory tract infection requiring hospitalization. 6. Presumed initial disease symptoms, similar to influenza/acute upper respiratory tract symptoms due to other infectious diseases, flu-like syndrome at the beginning of systemic connective tissue diseases, oncohematological and other diseases. 7. Medical history of primary and secondary immunodeficiencies. 8. Medical history of sarcoidosis. 9. Patients with diabetes or severe chronic heart, liver, kidney or brain disease. 10. Oncological diseases. 11. Exacerbation or decompensation of chronic diseases affecting the ability to participate in the clinical trial. 12. Medical history of polyvalent allergy. 13. Allergy/intolerance to some of ingredients of the tested product used upon the treatment. 14. Malabsorption syndrome, including congenital or acquired lactase or other disaccharide deficit, galactosemia. 15. Drug addiction, consumption of 2 or more alcohol units per day by the patient. 16. Mental disorders of the patient. 17. Patients according to the researcher's opinion, shall not comply with the study requirements or product dosing regimen. 18. Participation in other clinical trials within 3 months prior to study inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Number of clinically recovered patients. Clinical recovery: patients are considered clinically recovered only if the following criteria are all met: all symptoms are improved to 'Lack of symptoms' or 'Very mild' (the severity of each clinical symptom decreased to =2 points and there is no complaint persistence by the end of the trial period), as their summary score is =12 points and it is determined by the sum of the severity of each symptom. In addition, axillary temperature has been permanently reduced to <37.0°C (there are two consecutive measurements at every 12 hours, where the value is <37.0°C) and no complaint persistence by the end of the trial period, in addition, the value of the measured axillary temperature is <37.0°C, without antipyretics taking. 2. Average disease duration, defined as the interval between the initiation of treatment and the period where the patient meets the criteria for “Clinically well” in all 3 studies. The severity of symptoms (headache, fatigue/easy fatigue, sleep disturbances, nasal congestion, sore throat, cough) will be evaluated by a Visual Pain Scale for the symptoms severity (0 = Lack of symptoms; 2 = Very mild symptoms; 4 = Mild symptoms; 6 = Moderate symptoms; 8 = Severe symptoms, 10 = Very severe) and will be recorded in the patient diary data. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Temperature measured using standard electronic pen thermometers at baseline and up to the recovery period (Days 1-5 or 1-7), at 12-hour intervals 2. Symptoms and severity of each symptom: headache, fatigue/easy fatigue, sleep disturbances, nasal congestion, sore throat, cough. The severity of each symptom will be evaluated by a VAS (0-10) for the symptom severity (0 = Lack of symptoms; 2 = Very mild symptoms; 4 = Mild symptoms; 6 = Moderate symptoms; 8 = Severe symptoms, 10 = Very severe) at baseline and up to the recovery period (Days 1-5 or 1-7), at 12-hour intervals | — |
Countries
Bulgaria
Outcome results
None listed