Acute Upper Respiratory Infections
Conditions
Brief summary
Purpose of the study: * To assess efficacy of Anaferon for children liquid dosage form in the treatment of acute upper respiratory tract infections. * To assess safety of Anaferon for children liquid dosage form in the treatment of acute upper respiratory tract infections.
Interventions
DRUGAnaferon for children (liquid dosage form)
10 drops per dose. Day 1: 10 drops every 30 minutes for the first 2 hours, followed by three more doses regularly spaced during the rest of the day. Day 2 to 5: 10 drops three times daily.
DRUGPlacebo (liquid dosage form)
10 drops per dose. Day 1: 10 drops every 30 minutes for the first 2 hours, followed by three more doses regularly spaced during the rest of the day. Day 2 to 5: 10 drops three times daily.
Sponsors
Materia Medica Holding
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Months to 3 Years
Healthy volunteers
No
Inclusion criteria
1. Patients of both sexes aged 1 month to 3 years. 2. Diagnosis of acute upper respiratory infection based on a doctor's examination of the patient: body temperature at least 37.8°C when visiting a doctor + symptom scores ≥3 (presence of at least 1 general symptom and 1 nasal/ throat/chest symptom). 3. The first 24 hours from the beginning of manifestations of acute upper respiratory infection. 4. Acute respiratory viral infections season. 5. The possibility to start treatment within 24 hours of the onset of acute upper respiratory infection symptoms. 6. Availability of a patient information sheet (Informed Consent form) signed by the patient's parents/adopters to confirm the child's participation in the clinical trial signed by one parent/adopter of patient.
Exclusion criteria
1. Suspected pneumonia or bacterial infection or the presence of a disease requiring usage of antibacterial drugs starting from day 1 of the illness onset. 2. Clinical symptoms of severe influenza/ARI (acute respiratory infection) requiring hospitalization. 3. Suspected early manifestations of diseases that have symptoms similar to ARI symptoms (other infectious diseases, influenza-like syndrome at the onset of systemic connective tissue disorders, hematologic neoplasms and other pathology). 4. Documented (prior diagnosis) or suspected disease such as * primary or secondary immunodeficiency: а) lymphoid immunodeficiency (T-cell and/or B-cell immunity, immunodeficiencies with predominant antibody deficit, b) phagocyte deficits; c) complement factor deficit; d) combined immunodeficiency including AIDS secondary to HIV infection; toxic, autoimmune, infectious, or radial panleukopenia syndrome; general lymphocytopenia syndrome; syndrome of lymphocyte polyclonal activation; postsplenectomia syndrome; congenital asplenia; syndrome of immune complexes pathology associated with infectious, autoimmune and allergic diseases; * cystic fibrosis, primary ciliary dyskinesia, bronchopulmonary dysplasia, congenital malformations of the respiratory system, including malformations of upper respiratory tract, and other chronic lung disease; * malignant neoplasm. 5. Exacerbation or decompensation of chronic diseases affecting ability to participate in the clinical study. 6. Medical history of polyvalent allergy. 7. Allergy/ intolerance to any of the components of medications used in the treatment. 8. Use of medications listed in 'Prohibited concomitant treatments/medications' within 2 weeks before study entry. 9. Drug use or alcohol use (more than 2 alc. units daily) by the patient's parent(s)/adopter(s). 10. Mental disorders of patient's parent(s)/adopter(s). 11. Patients whose parents/adopters, from the investigator's point of view, will fail to comply with the observation requirements of the trial or with the intake regimen of the investigated medicines. 12. Participation in other clinical studies in the course of 3 months (or 1-2 months for infants under two months of age) prior to the inclusion in the trial. 13. Patient's parents/adopters are related to the clinical trial site's research staff 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. 14. The patient's parent/adopter works for OOO NPF MATERIA MEDICA HOLDING (i.e., the company's employee, part-time employee under contract or appointed official in charge of the trial, or their immediate family).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Illness Duration (the Interval Between the Start of the Trial Treatment and the Time When Recovery/Improvement - Based on Patient Diary Data) | From the time of randomization until the time of recovery/improvement, assessed up to 14 days | based on patient diary data |
| Severity of the Disease Within 5 Days Was Assessed Using the Area Under the Curve for the Total Symptom Score (TSS) at 1-5 Days (According to the Diary of the Patient). | On days 1-5 of observation | The TSS was based on the severity of each of acute upper respiratory tract infection (URTI) symptom. The TSS includes 11 symptoms: Body temperature / fever, Non-specific URTI symptoms (Decreased activity / Malaise, Impaired appetite / refusal of feeding, Painful appearance, Sleep disturbance) and Nose /Throat symptoms (Runny nose, Nasal congestion, Sneezing, Hoarseness, Sore throat, Cough). The severity of each URTI symptom was scored on a symptom severity scale (0 = no symptoms; 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms). Minimum score=0; maximum score=33. The severity of URTI symptoms was recorded by one of the patient's parents/adopter on a diary card twice a day (morning and evening) on Days 1-5. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Body Temperatures, Measured in the Morning and Evening on Days 2-5 (Based on Patient Diary Data) | On Days 2-5 of the treatment | based on patient diary data |
| Percentage of Patients With Body Temperature ≤37.30С on Days 2-5 of Observation | On Days 2-5 of observation | based on patient diary data |
| Total Symptom Score on Days 3 and 6 of Observation Based on the Results of Pediatrician's Examination | On Days 1, 3, 6 of the treatment | The Total Symptom Score (TSS) was based on the severity of each of acute upper respiratory tract infection (URTI) symptom. The TSS includes 11 symptoms: Body temperature / fever, Non-specific URTI symptoms (Decreased activity / Malaise, Impaired appetite / refusal of feeding, Painful appearance, Sleep disturbance) and Nose /Throat symptoms (Runny nose, Nasal congestion, Sneezing, Hoarseness, Sore throat, Cough). The severity of each URTI symptom was scored on a symptom severity scale (0 = no symptoms; 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms). Minimum score=0; maximum score=33. The severity of URTI symptoms was recorded by the study researchers (pediatricians) on the case record form on Days 1, 3, 6. |
| Percentage of Patients With Recovery on Days 2, 3, 4 and 5 of Observation (Based on Patient Diary Data) | On Days 2-5 of the treatment | based on patient diary data |
| Number of Antipyretic Use (for Prescribed Indications) on Days 1-5 of Treatment (Based on Patient Diary Data) | on Days 1-5 of treatment | based on patient diary data |
| Percentage of Patients With Complications of Illness, Including Those Requiring Antibiotic Administration or Hospitalization) for 14 Days of Observation | From the time of randomization up to 14 days | — |
| Severity of the Disease Within 5 Days Was Assessed Using the Area Under the Curve for the Total Symptom Score (TSS) on Days 1, 3, 6 (According to the Results of Pediatrician's Examination) | on Days 1, 3, 6 | The TSS was based on the severity of each of acute upper respiratory tract infection (URTI) symptom. The TSS includes 11 symptoms: Body temperature / fever, Non-specific URTI symptoms (Decreased activity / Malaise, Impaired appetite / refusal of feeding, Painful appearance, Sleep disturbance) and Nose /Throat symptoms (Runny nose, Nasal congestion, Sneezing, Hoarseness, Sore throat, Cough). The severity of each URTI symptom was scored on a symptom severity scale (0 = no symptoms; 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms). Minimum score=0; maximum score=33. The severity of URTI symptoms was recorded by the study researchers (pediatricians) on the case record form on Days 1, 3, 6. |
| Average Duration of Fever (i.e. Body Temperature >37.3°С) | From the time of randomization until the time of normal body temperature, assessed up to 14 days | based on patient diary data |
Countries
Russia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Anaferon for Children Anaferon for children (liquid dosage form): 10 drops per dose. Day 1: 10 drops every 30 minutes for the first 2 hours, followed by three more doses regularly spaced during the rest of the day. Day 2 to 5: 10 drops three times daily. | 71 |
| Placebo Placebo (liquid dosage form): 10 drops per dose. Day 1: 10 drops every 30 minutes for the first 2 hours, followed by three more doses regularly spaced during the rest of the day. Day 2 to 5: 10 drops three times daily. | 71 |
| Total | 142 |
Baseline characteristics
| Characteristic | Anaferon for Children | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 1.8 years STANDARD_DEVIATION 1 | 1.9 years STANDARD_DEVIATION 1 | 1.9 years STANDARD_DEVIATION 1 |
| Region of Enrollment Russia | 71 Participants | 71 Participants | 142 Participants |
| Sex: Female, Male Female | 36 Participants | 32 Participants | 68 Participants |
| Sex: Female, Male Male | 35 Participants | 39 Participants | 74 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 7 / 71 | 4 / 71 |
| serious Total, serious adverse events | 0 / 71 | 0 / 71 |
Outcome results
Primary
Average Illness Duration (the Interval Between the Start of the Trial Treatment and the Time When Recovery/Improvement - Based on Patient Diary Data)
based on patient diary data
Time frame: From the time of randomization until the time of recovery/improvement, assessed up to 14 days
Population: Intention to treat set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anaferon for Children | Average Illness Duration (the Interval Between the Start of the Trial Treatment and the Time When Recovery/Improvement - Based on Patient Diary Data) | 87.7 hours | Standard Deviation 31.5 |
| Placebo | Average Illness Duration (the Interval Between the Start of the Trial Treatment and the Time When Recovery/Improvement - Based on Patient Diary Data) | 103.3 hours | Standard Deviation 19.4 |
p-value: 0.007Wilcoxon (Mann-Whitney)
Primary
Severity of the Disease Within 5 Days Was Assessed Using the Area Under the Curve for the Total Symptom Score (TSS) at 1-5 Days (According to the Diary of the Patient).
The TSS was based on the severity of each of acute upper respiratory tract infection (URTI) symptom. The TSS includes 11 symptoms: Body temperature / fever, Non-specific URTI symptoms (Decreased activity / Malaise, Impaired appetite / refusal of feeding, Painful appearance, Sleep disturbance) and Nose /Throat symptoms (Runny nose, Nasal congestion, Sneezing, Hoarseness, Sore throat, Cough). The severity of each URTI symptom was scored on a symptom severity scale (0 = no symptoms; 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms). Minimum score=0; maximum score=33. The severity of URTI symptoms was recorded by one of the patient's parents/adopter on a diary card twice a day (morning and evening) on Days 1-5.
Time frame: On days 1-5 of observation
Population: Intention to treat set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anaferon for Children | Severity of the Disease Within 5 Days Was Assessed Using the Area Under the Curve for the Total Symptom Score (TSS) at 1-5 Days (According to the Diary of the Patient). | 25.6 AUC score*day | Standard Deviation 17.2 |
| Placebo | Severity of the Disease Within 5 Days Was Assessed Using the Area Under the Curve for the Total Symptom Score (TSS) at 1-5 Days (According to the Diary of the Patient). | 33.6 AUC score*day | Standard Deviation 17.7 |
p-value: 0.0004Wilcoxon (Mann-Whitney)
Secondary
Average Duration of Fever (i.e. Body Temperature >37.3°С)
based on patient diary data
Time frame: From the time of randomization until the time of normal body temperature, assessed up to 14 days
Population: Intention to treat set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anaferon for Children | Average Duration of Fever (i.e. Body Temperature >37.3°С) | 47.3 hours | Standard Deviation 30.3 |
| Placebo | Average Duration of Fever (i.e. Body Temperature >37.3°С) | 57.0 hours | Standard Deviation 31.6 |
p-value: 0.051Wilcoxon (Mann-Whitney)
Secondary
Mean Body Temperatures, Measured in the Morning and Evening on Days 2-5 (Based on Patient Diary Data)
based on patient diary data
Time frame: On Days 2-5 of the treatment
Population: Intention to treat set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Anaferon for Children | Mean Body Temperatures, Measured in the Morning and Evening on Days 2-5 (Based on Patient Diary Data) | Day 5, Morning | 36.7 °C | Standard Deviation 0.5 |
| Anaferon for Children | Mean Body Temperatures, Measured in the Morning and Evening on Days 2-5 (Based on Patient Diary Data) | Day 2, Morning | 37.4 °C | Standard Deviation 0.7 |
| Anaferon for Children | Mean Body Temperatures, Measured in the Morning and Evening on Days 2-5 (Based on Patient Diary Data) | Day 3, Morning | 37.0 °C | Standard Deviation 0.6 |
| Anaferon for Children | Mean Body Temperatures, Measured in the Morning and Evening on Days 2-5 (Based on Patient Diary Data) | Day 4, Morning | 36.9 °C | Standard Deviation 0.6 |
| Anaferon for Children | Mean Body Temperatures, Measured in the Morning and Evening on Days 2-5 (Based on Patient Diary Data) | Day 2, Evening | 37.4 °C | Standard Deviation 0.8 |
| Anaferon for Children | Mean Body Temperatures, Measured in the Morning and Evening on Days 2-5 (Based on Patient Diary Data) | Day 3, Evening | 37.1 °C | Standard Deviation 0.7 |
| Anaferon for Children | Mean Body Temperatures, Measured in the Morning and Evening on Days 2-5 (Based on Patient Diary Data) | Day 4, Evening | 36.9 °C | Standard Deviation 0.6 |
| Anaferon for Children | Mean Body Temperatures, Measured in the Morning and Evening on Days 2-5 (Based on Patient Diary Data) | Day 5, Evening | 36.7 °C | Standard Deviation 0.3 |
| Placebo | Mean Body Temperatures, Measured in the Morning and Evening on Days 2-5 (Based on Patient Diary Data) | Day 5, Evening | 36.8 °C | Standard Deviation 0.5 |
| Placebo | Mean Body Temperatures, Measured in the Morning and Evening on Days 2-5 (Based on Patient Diary Data) | Day 5, Morning | 36.7 °C | Standard Deviation 0.6 |
| Placebo | Mean Body Temperatures, Measured in the Morning and Evening on Days 2-5 (Based on Patient Diary Data) | Day 2, Evening | 37.5 °C | Standard Deviation 0.8 |
| Placebo | Mean Body Temperatures, Measured in the Morning and Evening on Days 2-5 (Based on Patient Diary Data) | Day 2, Morning | 37.6 °C | Standard Deviation 0.7 |
| Placebo | Mean Body Temperatures, Measured in the Morning and Evening on Days 2-5 (Based on Patient Diary Data) | Day 4, Evening | 36.9 °C | Standard Deviation 0.6 |
| Placebo | Mean Body Temperatures, Measured in the Morning and Evening on Days 2-5 (Based on Patient Diary Data) | Day 3, Morning | 37.1 °C | Standard Deviation 0.5 |
| Placebo | Mean Body Temperatures, Measured in the Morning and Evening on Days 2-5 (Based on Patient Diary Data) | Day 3, Evening | 37.1 °C | Standard Deviation 0.6 |
| Placebo | Mean Body Temperatures, Measured in the Morning and Evening on Days 2-5 (Based on Patient Diary Data) | Day 4, Morning | 36.9 °C | Standard Deviation 0.4 |
Comparison: Mean body temperatures, measured in the morning on Days 2-5 (based on patient diary data)p-value: 0.19ANOVA
Comparison: Mean body temperatures, measured in the evening on Days 2-5 (based on patient diary data)p-value: 0.44ANOVA
Secondary
Number of Antipyretic Use (for Prescribed Indications) on Days 1-5 of Treatment (Based on Patient Diary Data)
based on patient diary data
Time frame: on Days 1-5 of treatment
Population: Intention to treat set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Anaferon for Children | Number of Antipyretic Use (for Prescribed Indications) on Days 1-5 of Treatment (Based on Patient Diary Data) | Day 2 | 0.5 Number of intakes | Standard Deviation 1.1 |
| Anaferon for Children | Number of Antipyretic Use (for Prescribed Indications) on Days 1-5 of Treatment (Based on Patient Diary Data) | Day 4 | 0.2 Number of intakes | Standard Deviation 0.7 |
| Anaferon for Children | Number of Antipyretic Use (for Prescribed Indications) on Days 1-5 of Treatment (Based on Patient Diary Data) | Day 3 | 0.2 Number of intakes | Standard Deviation 0.7 |
| Anaferon for Children | Number of Antipyretic Use (for Prescribed Indications) on Days 1-5 of Treatment (Based on Patient Diary Data) | Day 5 | 0.1 Number of intakes | Standard Deviation 0.3 |
| Anaferon for Children | Number of Antipyretic Use (for Prescribed Indications) on Days 1-5 of Treatment (Based on Patient Diary Data) | Day 1 | 0.8 Number of intakes | Standard Deviation 0.9 |
| Placebo | Number of Antipyretic Use (for Prescribed Indications) on Days 1-5 of Treatment (Based on Patient Diary Data) | Day 5 | 0.1 Number of intakes | Standard Deviation 0.4 |
| Placebo | Number of Antipyretic Use (for Prescribed Indications) on Days 1-5 of Treatment (Based on Patient Diary Data) | Day 1 | 0.7 Number of intakes | Standard Deviation 0.9 |
| Placebo | Number of Antipyretic Use (for Prescribed Indications) on Days 1-5 of Treatment (Based on Patient Diary Data) | Day 2 | 0.5 Number of intakes | Standard Deviation 0.8 |
| Placebo | Number of Antipyretic Use (for Prescribed Indications) on Days 1-5 of Treatment (Based on Patient Diary Data) | Day 3 | 0.2 Number of intakes | Standard Deviation 0.5 |
| Placebo | Number of Antipyretic Use (for Prescribed Indications) on Days 1-5 of Treatment (Based on Patient Diary Data) | Day 4 | 0.1 Number of intakes | Standard Deviation 0.5 |
p-value: 0.63ANOVA
Secondary
Percentage of Patients With Body Temperature ≤37.30С on Days 2-5 of Observation
based on patient diary data
Time frame: On Days 2-5 of observation
Population: Intention to treat set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Anaferon for Children | Percentage of Patients With Body Temperature ≤37.30С on Days 2-5 of Observation | Day 3 | 56.3 percentage of participants |
| Anaferon for Children | Percentage of Patients With Body Temperature ≤37.30С on Days 2-5 of Observation | Day 2 | 28.2 percentage of participants |
| Anaferon for Children | Percentage of Patients With Body Temperature ≤37.30С on Days 2-5 of Observation | Day 4 | 73.2 percentage of participants |
| Anaferon for Children | Percentage of Patients With Body Temperature ≤37.30С on Days 2-5 of Observation | Day 5 | 88.7 percentage of participants |
| Placebo | Percentage of Patients With Body Temperature ≤37.30С on Days 2-5 of Observation | Day 5 | 83.1 percentage of participants |
| Placebo | Percentage of Patients With Body Temperature ≤37.30С on Days 2-5 of Observation | Day 3 | 43.7 percentage of participants |
| Placebo | Percentage of Patients With Body Temperature ≤37.30С on Days 2-5 of Observation | Day 4 | 74.7 percentage of participants |
| Placebo | Percentage of Patients With Body Temperature ≤37.30С on Days 2-5 of Observation | Day 2 | 12.7 percentage of participants |
p-value: 0.15Log Rank
Secondary
Percentage of Patients With Complications of Illness, Including Those Requiring Antibiotic Administration or Hospitalization) for 14 Days of Observation
Time frame: From the time of randomization up to 14 days
Population: Intention to treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Anaferon for Children | Percentage of Patients With Complications of Illness, Including Those Requiring Antibiotic Administration or Hospitalization) for 14 Days of Observation | 2.8 percentage of participants |
| Placebo | Percentage of Patients With Complications of Illness, Including Those Requiring Antibiotic Administration or Hospitalization) for 14 Days of Observation | 4.2 percentage of participants |
p-value: 1Fisher Exact
Secondary
Percentage of Patients With Recovery on Days 2, 3, 4 and 5 of Observation (Based on Patient Diary Data)
based on patient diary data
Time frame: On Days 2-5 of the treatment
Population: Intention to treat set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Anaferon for Children | Percentage of Patients With Recovery on Days 2, 3, 4 and 5 of Observation (Based on Patient Diary Data) | Day 2 | 9.9 percentage of participants |
| Anaferon for Children | Percentage of Patients With Recovery on Days 2, 3, 4 and 5 of Observation (Based on Patient Diary Data) | Day 3 | 29.6 percentage of participants |
| Anaferon for Children | Percentage of Patients With Recovery on Days 2, 3, 4 and 5 of Observation (Based on Patient Diary Data) | Day 4 | 39.4 percentage of participants |
| Anaferon for Children | Percentage of Patients With Recovery on Days 2, 3, 4 and 5 of Observation (Based on Patient Diary Data) | Day 5 | 64.8 percentage of participants |
| Placebo | Percentage of Patients With Recovery on Days 2, 3, 4 and 5 of Observation (Based on Patient Diary Data) | Day 5 | 57.8 percentage of participants |
| Placebo | Percentage of Patients With Recovery on Days 2, 3, 4 and 5 of Observation (Based on Patient Diary Data) | Day 2 | 0 percentage of participants |
| Placebo | Percentage of Patients With Recovery on Days 2, 3, 4 and 5 of Observation (Based on Patient Diary Data) | Day 4 | 18.3 percentage of participants |
| Placebo | Percentage of Patients With Recovery on Days 2, 3, 4 and 5 of Observation (Based on Patient Diary Data) | Day 3 | 4.2 percentage of participants |
p-value: 0.055Log Rank
Secondary
Severity of the Disease Within 5 Days Was Assessed Using the Area Under the Curve for the Total Symptom Score (TSS) on Days 1, 3, 6 (According to the Results of Pediatrician's Examination)
The TSS was based on the severity of each of acute upper respiratory tract infection (URTI) symptom. The TSS includes 11 symptoms: Body temperature / fever, Non-specific URTI symptoms (Decreased activity / Malaise, Impaired appetite / refusal of feeding, Painful appearance, Sleep disturbance) and Nose /Throat symptoms (Runny nose, Nasal congestion, Sneezing, Hoarseness, Sore throat, Cough). The severity of each URTI symptom was scored on a symptom severity scale (0 = no symptoms; 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms). Minimum score=0; maximum score=33. The severity of URTI symptoms was recorded by the study researchers (pediatricians) on the case record form on Days 1, 3, 6.
Time frame: on Days 1, 3, 6
Population: Intention to treat set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anaferon for Children | Severity of the Disease Within 5 Days Was Assessed Using the Area Under the Curve for the Total Symptom Score (TSS) on Days 1, 3, 6 (According to the Results of Pediatrician's Examination) | 12.6 AUC score*day | Standard Deviation 7 |
| Placebo | Severity of the Disease Within 5 Days Was Assessed Using the Area Under the Curve for the Total Symptom Score (TSS) on Days 1, 3, 6 (According to the Results of Pediatrician's Examination) | 16.0 AUC score*day | Standard Deviation 7.6 |
p-value: 0.001Wilcoxon (Mann-Whitney)
Secondary
Total Symptom Score on Days 3 and 6 of Observation Based on the Results of Pediatrician's Examination
The Total Symptom Score (TSS) was based on the severity of each of acute upper respiratory tract infection (URTI) symptom. The TSS includes 11 symptoms: Body temperature / fever, Non-specific URTI symptoms (Decreased activity / Malaise, Impaired appetite / refusal of feeding, Painful appearance, Sleep disturbance) and Nose /Throat symptoms (Runny nose, Nasal congestion, Sneezing, Hoarseness, Sore throat, Cough). The severity of each URTI symptom was scored on a symptom severity scale (0 = no symptoms; 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms). Minimum score=0; maximum score=33. The severity of URTI symptoms was recorded by the study researchers (pediatricians) on the case record form on Days 1, 3, 6.
Time frame: On Days 1, 3, 6 of the treatment
Population: Intention to treat set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Anaferon for Children | Total Symptom Score on Days 3 and 6 of Observation Based on the Results of Pediatrician's Examination | Day 1 | 11.8 Score | Standard Deviation 3.9 |
| Anaferon for Children | Total Symptom Score on Days 3 and 6 of Observation Based on the Results of Pediatrician's Examination | Day 3 | 6.0 Score | Standard Deviation 4.7 |
| Anaferon for Children | Total Symptom Score on Days 3 and 6 of Observation Based on the Results of Pediatrician's Examination | Day 6 | 1.9 Score | Standard Deviation 2.7 |
| Placebo | Total Symptom Score on Days 3 and 6 of Observation Based on the Results of Pediatrician's Examination | Day 1 | 12.5 Score | Standard Deviation 4.6 |
| Placebo | Total Symptom Score on Days 3 and 6 of Observation Based on the Results of Pediatrician's Examination | Day 3 | 8.0 Score | Standard Deviation 4.6 |
| Placebo | Total Symptom Score on Days 3 and 6 of Observation Based on the Results of Pediatrician's Examination | Day 6 | 2.8 Score | Standard Deviation 4.8 |
p-value: 0.004ANOVA