A Study on the Efficacy and Safety of Benzonatate Soft Capsules for Improving Adult Cough Symptoms

Study Overview
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Brief Summary
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The purpose of this study is evaluate the efficay and safety of benzonatate soft capsules for improving adult cough symtoms.

Detailed Description
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The purpose of this study is evaluate the efficay and safety of benzonatate soft capsules for improving adult cough symtoms. The study was designed to be randomized, double-blind, placebo-controlled.Subjects were randomly assigned to the benzonatate soft capsule group and the placebo group on a 1:1 basis。According to the regulatory requirements, 200 cases were planned to be included. Considering that poor efficacy of the placebo control group might lead to shedding, a 10% increase in shedding was achieved, and 220 cases were finally determined, with 110 cases in each group.

Official Title
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A Multicentric Randomized Double-blind Placebo-controlled Study on the Efficacy and Safety of Benzonatate Soft Capsules for Improving Adult Cough Symptoms

Conditions
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Cough

Intervention / Treatment
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* Drug: Benzonatate 200 mg
* Drug: blank control 0mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age between 18 and 75 years of age; the onset time is more than 3 days and less than 8 weeks; dry cough, the total score of cough symptom in day and night is greater than 4; Willing to sign informed consent. Exclusion Criteria: allergic person or known to the test drug containing ingredients (including benzo, soybean oil, glycerin, gelatin) allergy; the cough symptoms are caused by bronchial asthma, tuberculosis, pneumoconiosis, bronchiectasis, tumor and other diseases that have been clearly diagnosed. coughers caused by drugs; respiratory depression or airway obstruction; patients with uncontrolled diabetes or hypertension; having difficulty in swallowing or affecting drug absorption, such as active peptic ulcer and acute gastritis; patients with severe hematopoietic system, nervous system, mental illness (including alcohol and substance abuse) or immunodeficiency diseases; laboratory examination results are abnormal with clinical significance, among which: A.C r is higher than normal value; B.A LT and/or AST>2 times normal value upper limit (ULN). women during pregnancy or lactation or women who are preparing for pregnancy or lactation during the trial; in the first 3 months of screening, any other experimental drug treatment was accepted; Failure to comply with test plans or other conditions that other researchers believe is not appropriate for the group.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: benzonatate soft capsules group<br> | Drug: Benzonatate 200 mg<br>* 200 mg/pellet, 1pellet/time, 3times/day<br>|
| Placebo Comparator: control group<br> | Drug: blank control 0mg<br>* 0 mg/pellet, 1pellet/time, 3times/day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reducion of cough symptoms total scores | The reduction of cough symptoms will be evaluated by comparative score index basal and final score | 7days |