Clinical trial NCT03132610: A Study of Andrographolide Sulfonate in Patients With Acute Exacerbation of Chronic Bronchitis
Official title: Efficacy and Safety of Combined With Andrographolide Sulfonate on the Basis of Conventional Therapy in Patients With Acute Exacerbation of Chronic Bronchitis: a Randomized, Single Blind, Placebo-controlled, Multicenter Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Acute Exacerbation of Chronic Bronchitis
Lead sponsor: Jiangxi Qingfeng Pharmaceutical Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2017-04-28
Enrollment: 240
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: A multicenter,randomized,single-blind, placebo-controlled,phase 4 clinical trial to evaluate the efficacy and safety of andrographolide sulfonate in patients with acute exacerbation of chronic bronchitis

Detailed description: The patient after passing the screening, with the ratio of 1:1, were randomly assigned to experimental group or control group. Experimental group: on the basis of Conventional Therapy,Xiyanping injection(andrographolide sulfonate) 10-20ml/d, With 0.9% normal saline 100ml-250ml diluted intravenous drip (not with other drugs in the same container mixed use), control drip speed per minute of 30-40 drops. control group: on the basis of Conventional Therapy,Xiyanping injection simulation(0.9% normal saline) 10-20ml/d, The treatment method is the same as the experimental group.

Eligibility criteria: Inclusion Criteria:

* 1.18-75 years, males or females;
* 2.patients met the acute exacerbation of chronic bronchitis diagnosis;
* 3.Patients with bronchitis were acute attacked 2-6 days,who had a history of chronic bronchitis more than 2 years.
* 4. Patients compliance is good, written informed consent was obtained from all participants before the study.

Exclusion Criteria:

* 1.Patients had a history of andrographolide sulfonate or andrographolide allergy.
* 2.Pregnancy, lactation, and absence of contraception in women of fertile age.
* 3.Judging by the researchers, Past or present illness of patients may affect to participate in the trial or affect the outcome of the study, including cardio-pulmonary diseases, malignant diseases, autoimmune diseases, hepatorenal disease, blood diseases, nervous system diseases, immune system diseases and endocrine diseases
* 4.After checking, Patients with pulmonary tuberculosis, bronchial asthma, bronchial pneumonia, bronchiectasis, pneumoconiosis, silicosis, lung cancer, pulmonary infiltration or other allergic respiratory diseases and other chronic lung diseases
* 5.Patients using systemic steroids or other immunosuppressive therapy
* 6.Patients with severe cardiopulmonary dysfunction, abnormal liver and kidney function, blood system diseases
* 7.Patients are alcohol (daily drink alcoholic wine is more than 40g) or drug abuse or drug addicts in the past year.
* 8.Patients were participated in any study of drug trials in the last 30 days.
* 9.According to the researchers' judgment, anyone who are not suitable for the study.

Primary outcomes:
measure: cured rate
timeFrame: less than 14 days
Secondary outcomes:
measure: effective time window
timeFrame: less than 14 days
measure: days of antibiotic use
timeFrame: less than 14 days
measure: the incidence of complications
timeFrame: less than 14 days
measure: bacterial eradication rate
timeFrame: less than 14 days
measure: direct medical cost
timeFrame: less than 14 days
measure: number of participants with treatment-related adverse events
timeFrame: less than 14 days
Other outcomes:
Locations:
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Jiangxi
Study officials:
affiliation: The First Affiliated Hospital of Nanchang University
name: Wei Zhang
role: PRINCIPAL_INVESTIGATOR
affiliation: The Fourth Affiliated Hospital of Nanchang University
name: Ping Xu
role: PRINCIPAL_INVESTIGATOR
References: