To Evaluate the Clinical Efficacy and Safety of Recombinant Human Interferon ω Spray in Treatment of Viral Upper Respiratory Tract Infection in Children

Study Overview
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Brief Summary
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To evaluate the clinical efficacy and safety of recombinant human interferon ω spray in treatment of viral upper respiratory tract infection in children aged by 3-12 years, and to explore the appropriate usage and dosage of the drug in treatment of upper respiratory tract infection caused by viruses.

Detailed Description
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This study is a prospective, randomized, double-blind, double-simulated, placebo parallel-controlled, multi-center clinical study. Children who met the inclusion criteria of viral upper respiratory tract infection in eligible children aged by 3-12 years will be enrolled. The study contained 3 treatment groups. Xiao'er Chaigui Tuire Keli and Xiao'er Feire Kechuan Keli were used as symptomatic treatment drugs in each group, and the two test groups additionally added to different doses of recombinant human interferon ω spray, placebo was added to the placebo group. This study is a prospective, randomized, double-blind, double-simulated, placebo parallel-controlled, multi-center clinical study. Children who met the inclusion criteria of viral upper respiratory tract infection in eligible children aged by 3-12 years will be enrolled. The study contained 3 treatment groups. Xiao'er Chaigui Tuire Keli and Xiao'er Feire Kechuan Keli were used as symptomatic treatment drugs in each group, and the two test groups additionally added to different doses of recombinant human interferon ω spray, placebo was added to the placebo group. In each group, each bottle of drug was sprayed 1 time, sprayed into the child's pharynx, 2 times/dayand should not eat or drink for 20 minutes after using the medicine, Xiao'er Chaigui Tuire Keli and Xiao'er Feire Kechuan Keli should be taken orally according to the doctor's instructions. The treatment period is 7 days. All subjects returned to the study site for evaluating the primary efficacy measures, secondary efficacy measures and safety measures on Treatment Day 7±1. Telephone follow-up was performed on Treatment Day 14±2.

Official Title
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A Prospective, Randomized, Double-blind, Double-simulated, Placebo Parallel-controlled, Multicenter Clinical Study on Safety and Efficacy of Recombinant Human Interferon ω Spray in Treatment of Viral Upper Respiratory Tract Infection in Children

Conditions
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Viral Upper Respiratory Tract Infection

Intervention / Treatment
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* Drug: recombinant human interferon ω spray


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 3 years old ≤ age ≤ 12 years old, gender unlimited； Routine blood test of white cells < Upper limit of normal value, C reactive protein < Upper limit of normal value. Meeting the description of the diagnostic criteria for viral upper respiratory tract infection in Zhufutang Practical Pediatrics； Body temperature ≥ 38 ℃（axillary temperature）； The guardian should give informed consent and sign the informed consent form (if the child is ≥ 10 years old, the child should also give informed consent and sign the informed consent form). Exclusion Criteria: Diagnosed as bacterial upper respiratory tract infection. Patients with onset time more than 72 hours. With severe cardiac, hepatic and renal insufficiency（ALT and AST are 1.5 times above the upper limit of normal value）, abnormal renal function（Scr abnormality） . Treated with antiviral drugs orally within two weeks or for external use within one week before inclusion. Participated in other clinical trials and took the study medication within one month before inclusion. People with low immune function, systemic failure or long-term use of glucocorticoids and immunosuppressants. Those who suffer from nervous and mental diseases and cannot cooperate well. Allergy constitution（allergic to more than two kinds of drugs or food）or known allergy to interferon and its matrix. Because of other diseases that affect the efficacy observer of this study. Other conditions considered by the investigator as not appropriate to participate in the study.

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, randomized, double-blind, double-simulated, placebo parallel-controlled, multicenter design
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low dose group<br>1 bottle of recombinant human interferon ω spray and 1 bottle of placebo（recombinant human interferon ω spray mimics）+base drugs（Xiao'er Changui Tuire granules and Xiao'er Feire Kechuan granules). Each bottle of medication is sprayed once, twice a day. After using the medication, no food or water can be consumed for 20 minutes. Follow the doctor's instructions for use of the base drugs. This treatment course can last up to 7 days. | Drug: recombinant human interferon ω spray<br>* 8 ml/bottle（contain 2 million IU recombinant human interferon ω）<br>|
| Experimental: High dose group<br>2 bottle of recombinant human interferon ω spray +base drugs（Xiao'er Changui Tuire granules and Xiao'er Feire Kechuan granules). Each bottle of medication is sprayed once, twice a day. After using the medication, no food or water can be consumed for 20 minutes. Follow the doctor's instructions for use of the base drugs. This treatment course can last up to 7 days. | Drug: recombinant human interferon ω spray<br>* 8 ml/bottle（contain 2 million IU recombinant human interferon ω）<br>|
| Placebo Comparator: Placebo group<br>2 bottle of placebo（recombinant human interferon ω spray mimics）+base drugs（Xiao'er Changui Tuire granules and Xiao'er Feire Kechuan granules). Each bottle of medication is sprayed once, twice a day. After using the medication, no food or water can be consumed for 20 minutes. Follow the doctor's instructions for use of the base drugs. This treatment course can last up to 7 days. | Drug: recombinant human interferon ω spray<br>* 8 ml/bottle（contain 2 million IU recombinant human interferon ω）<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete antipyretic time | the axillary temperature returns to normal （37.4℃） and remains for 24 h or more. | 0-7 days post each drug use | 
| Incidence of adverse reaction (AR) | Incidence of adverse reaction (AR) | 0-14 days post each drug use | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effective rate of relieving symptoms of upper respiratory tract infection | all symptoms of upper respiratory tract infection（nasal congestion, runny nose, sneezing, sore throat, cough）were alleviated efficiently. Judging the severity of the condition through scoring criteria. | 0-7 days post each drug use | 
| Recovery time | the time required for complete fever relief and all symptoms to be relieved | 0-7 days post each drug use | 
| Use rate of antimicrobial drugs and antipyretic drugs | Types and frequency of use of antibacterial and antipyretic drugs | 0-7 days post each drug use | 
| Incidence of complications | Incidence of complications | 0-7 days post each drug use | 
| Recurrence rate of cured subjects | Recurrence rate of cured subjects | 0-7 days post each drug use | 
| Laboratory examination | Changes in laboratory indicators，such as red blood cell count; platelet count; glutamic-pyruvic transaminase; urinary protein and so on. | 0-7 days post each drug use | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Viral Upper Respiratory Tract Infection, recombinant human interferon ω, Safety, Efficacy, 3-12 years