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

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

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

Study Overview

• Status: Unknown
• Conditions: Cough
• Intervention / Treatment: Drug: Benzonatate 200 mg; Drug: blank control 0mg

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 220
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100000
      • Recruiting
      • Beijing Hospital
      • Contact: Guo Yanfei, Master
    • Beijing, Beijing, China, 100000
      • Recruiting
      • Beijing Luhe Hospital Affiliated to Capital Medical University
      • Contact: Xu Zhenyang, Master
    • Beijing, Beijing, China, 100000
      • Recruiting
      • Beijing Pinggu District Hospital
      • Contact: Jin Xiuhong, Master
    • Beijing, Beijing, China, 100000
      • Recruiting
      • Peking University People's Hospital
      • Contact: Cao Zhaolong, M.D.
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150000
      • Recruiting
      • Second Affiliated Hospital of Harbin Medical University
      • Contact: Chen Hong, Master
  • Henan
    • Zhengzhou, Henan, China, 450000
      • Recruiting
      • Zhengzhou First People's Hospital
      • Contact: Chang Shuangxi, Master
  • Hunan
    • Changsha, Hunan, China, 410000
      • Recruiting
      • Second Hospital of Xiangya
      • Contact: Chen Ping, M.D.
  • Inner Mongolia
    • Hohhot, Inner Mongolia, China, 010000
      • Recruiting
      • Affiliated Hospital of Inner Mongolia Medical University
      • Contact: Wang Lihong, Master
    • Hohhot, Inner Mongolia, China, 010000
      • Recruiting
      • Inner Mongolia Autonomous Region People's Hospital
      • Contact: Yun Chunmei, Master
  • Jilin
    • Changchun, Jilin, China, 130000
      • Recruiting
      • First Hospital of Jilin University
      • Contact: Peng Liping, M.D.
    • Changchun, Jilin, China, 130000
      • Recruiting
      • Jilin Province People's Hospital
      • Contact: Li Hui, M.D.
  • Liaoning
    • Dalian, Liaoning, China, 116000
      • Recruiting
      • Affiliated Zhongshan Hospital Dalian University
      • Contact: Pei Fuyang, Master
    • Shenyang, Liaoning, China, 110000
      • Recruiting
      • First Affiliated Hospital of China Medical University
      • Contact: Kang Jian, M.D.
  • Shanghai
    • Shanghai, Shanghai, China, 200000
      • Recruiting
      • Central hospital of yangpu district, Shanghai
      • Contact: Xu Xiaowen, Master

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. age between 18 and 75 years of age;
2. the onset time is more than 3 days and less than 8 weeks;
3. dry cough, the total score of cough symptom in day and night is greater than 4;
4. Willing to sign informed consent.

Exclusion Criteria:

1. allergic person or known to the test drug containing ingredients (including benzo, soybean oil, glycerin, gelatin) allergy;
2. the cough symptoms are caused by bronchial asthma, tuberculosis, pneumoconiosis, bronchiectasis, tumor and other diseases that have been clearly diagnosed.
3. coughers caused by drugs;
4. respiratory depression or airway obstruction;
5. patients with uncontrolled diabetes or hypertension;
6. having difficulty in swallowing or affecting drug absorption, such as active peptic ulcer and acute gastritis;
7. patients with severe hematopoietic system, nervous system, mental illness (including alcohol and substance abuse) or immunodeficiency diseases;
8. 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).
9. women during pregnancy or lactation or women who are preparing for pregnancy or lactation during the trial;
10. in the first 3 months of screening, any other experimental drug treatment was accepted;
11. Failure to comply with test plans or other conditions that other researchers believe is not appropriate for the group.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
• Investigators: Principal Investigator: Cao Zhaolong, M.D., Peking University People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Anticipated): December 31, 2018
• Study Completion (Anticipated): July 31, 2019

Study Registration Dates

• First Submitted: October 25, 2018
• First Submitted That Met QC Criteria: October 25, 2018
• First Posted (Actual): October 29, 2018

Study Record Updates

• Last Update Posted (Actual): October 29, 2018
• Last Update Submitted That Met QC Criteria: October 25, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Cough; Respiratory System Agents; Antitussive Agents; Benzonatate
• Other Study ID Numbers: EY20170501

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No