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

Acute Exacerbation of Chronic Bronchitis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03132610
• Other study ID #: JXQF-XYP-1608
• Status: Recruiting
• Phase: Phase 4
• First received: April 13, 2017
• Last updated: April 26, 2017
• Start date: December 1, 2016
• Est. completion date: June 1, 2018

Study information

• Verified date: April 2017
• Source: Jiangxi Qingfeng Pharmaceutical Co. Ltd.
• Contact: Lang Lv
• Phone: +86 010-84682600
• Email: bjlll[@]qfyy.com.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: June 1, 2018
• Est. primary completion date: December 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Disease
• Acute Exacerbation of Chronic Bronchitis
• Bronchitis
• Bronchitis, Chronic

Intervention

Drug:
• andrographolide sulfonate
Conventional Therapy+Xiyanping injection
• andrographolide sulfonate simulation
Conventional Therapy+Xiyanping injection simulation

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Nanchang University	Nanchang	Jiangxi

Sponsors (1)

Lead Sponsor	Collaborator
Jiangxi Qingfeng Pharmaceutical Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	days of antibiotic use	oral anti infective drugs use days and intravenous anti infective drugs use days are recorded	less than 14 days
Secondary	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
Secondary	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
Secondary	direct medical cost	medical cost including hospital expenses, examine fee, medication fee, et al, relate to treatment in hospital	less than 14 days
Secondary	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