A Study of Andrographolide Sulfonate in Patients With Acute Exacerbation of Chronic Bronchitis

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Acute Exacerbation of Chronic Bronchitis

Intervention / Treatment
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* Drug: andrographolide sulfonate
* Drug: andrographolide sulfonate simulation


Participation Criteria
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Eligibility Criteria
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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.

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Experimental group<br>Conventional Therapy + Xiyanping injection(andrographolide sulfonate) | Drug: andrographolide sulfonate<br>* Conventional Therapy+Xiyanping injection<br>* Other names: Xiyanping injection;|
| Placebo Comparator: control group<br>Conventional Therapy + Xiyanping injection simulation/andrographolide sulfonate simulation(0.9% normal saline) | Drug: andrographolide sulfonate simulation<br>* Conventional Therapy+Xiyanping injection simulation<br>* Other names: Xiyanping injection simulation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cured rate | clinical symptoms(fever, cough, expectoration and gasp) and signs totally disappear, the period of lab tests（WBC,CRP, chest X-ray） return to normal is recorded。 | less than 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| effective time window | days range from treatment is received to the effectiveness is observed, and symptoms disappear (fever, cough, expectoration and gasp). | less than 14 days | 
| days of antibiotic use | oral anti infective drugs use days and intravenous anti infective drugs use days are recorded | less than 14 days | 
| the incidence of complications | such as, the incidence of Acute otitis media, acute rhinitis, acute bronchitis, acute bronchitis, and so on. | less than 14 days | 
| bacterial eradication rate | bacterial eradication rate=Sputum culture negative cases after treatment /sputum culture positive cases before treatment x 100% =Sputum culture negative cases after treatment /sputum culture positive cases before treatment x 100% | less than 14 days | 
| direct medical cost | medical cost including hospital expenses, examine fee, medication fee, et al, relate to treatment in hospital | less than 14 days | 
| number of participants with treatment-related adverse events | the total incidence of adverse events, the incidence of adverse events associated with Xiyanping injection, the incidence of patients with grade 3 through grade 4 adverse events that are related to study drug, graded according to NCI-CTC V4.0 . Observe and record all adverse events and serious adverse events, including physical examination, vital signs, laboratory tests (Hematology, blood biochemistry, urine routine, stool routine), ECG changes and so on. | less than 14 days |