Clinical trial NCT03722914: A Study on the Efficacy and Safety of Benzonatate Soft Capsules for Improving Adult Cough Symptoms
Official title: A Multicentric Randomized Double-blind Placebo-controlled Study on the Efficacy and Safety of Benzonatate Soft Capsules for Improving Adult Cough Symptoms
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Cough
Lead sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-10-29
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: reducion of cough symptoms total scores
timeFrame: 7days
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing hospital
state: Beijing
city: Beijing
country: China
facility: Beijing luhe hospital affiliated to capital medical university
state: Beijing
city: Beijing
country: China
facility: Beijing pinggu district hospital
state: Beijing
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
city: Harbin
country: China
facility: Second affiliated hospital of Harbin medical university
state: Heilongjiang
city: Zhengzhou
country: China
facility: Zhengzhou first people's hospital
state: Henan
city: Changsha
country: China
facility: Second Hospital of Xiangya
state: Hunan
city: Hohhot
country: China
facility: Affiliated hospital of Inner Mongolia medical university
state: Inner Mongolia
city: Hohhot
country: China
facility: Inner Mongolia autonomous region people's hospital
state: Inner Mongolia
city: Changchun
country: China
facility: First hospital of jilin university
state: Jilin
city: Changchun
country: China
facility: Jilin Province People's Hospital
state: Jilin
city: Dalian
country: China
facility: Affiliated Zhongshan Hospital Dalian University
state: Liaoning
city: Shenyang
country: China
facility: First Affiliated Hospital of China Medical University
state: Liaoning
city: Shanghai
country: China
facility: Central hospital of yangpu district, Shanghai
state: Shanghai
Study officials:
affiliation: Peking University People's Hospital
name: Cao Zhaolong, M.D.
role: PRINCIPAL_INVESTIGATOR
References: