NCT03162458已完成3 期
Multicenter Double-blind Placebo-controlled Parallel Group Randomized Clinical Trial of Efficacy and Safety of Anaferon for Children Liquid Dosage Form in the Treatment of Acute Upper Respiratory Infections
Materia Medica Holding7 个研究点 分布在 1 个国家目标入组 142 人开始时间: 2015年1月22日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 142
- 试验地点
- 7
- 主要终点
- Average Illness Duration (the Interval Between the Start of the Trial Treatment and the Time When Recovery/Improvement - Based on Patient Diary Data)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Month 至 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of both sexes aged 1 month to 3 years.
- •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).
- •The first 24 hours from the beginning of manifestations of acute upper respiratory infection.
- •Acute respiratory viral infections season.
- •The possibility to start treatment within 24 hours of the onset of acute upper respiratory infection symptoms.
- •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.
排除标准
- •Suspected pneumonia or bacterial infection or the presence of a disease requiring usage of antibacterial drugs starting from day 1 of the illness onset.
- •Clinical symptoms of severe influenza/ARI (acute respiratory infection) requiring hospitalization.
- •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).
- •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.
- •Exacerbation or decompensation of chronic diseases affecting ability to participate in the clinical study.
- •Medical history of polyvalent allergy.
- •Allergy/ intolerance to any of the components of medications used in the treatment.
- •Use of medications listed in 'Prohibited concomitant treatments/medications' within 2 weeks before study entry.
- •Drug use or alcohol use (more than 2 alc. units daily) by the patient's parent(s)/adopter(s).
- •Mental disorders of patient's parent(s)/adopter(s).
- •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.
- •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.
- •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.
- •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).
研究组 & 干预措施
Anaferon for children
Experimental
干预措施: Anaferon for children (liquid dosage form) (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (liquid dosage form) (Drug)
结局指标
主要结局
Average Illness Duration (the Interval Between the Start of the Trial Treatment and the Time When Recovery/Improvement - Based on Patient Diary Data)
时间窗: 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).
时间窗: 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.
次要结局
- 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)
- Number of Antipyretic Use (for Prescribed Indications) on Days 1-5 of Treatment (Based on Patient Diary Data)(on Days 1-5 of treatment)
- 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)
- 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)
- 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)
- 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)
- 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)
- Percentage of Patients With Body Temperature ≤37.30С on Days 2-5 of Observation(On Days 2-5 of observation)
研究者
研究点 (7)
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