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

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

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

Study Overview

• Status: Unknown
• Conditions: Acute Exacerbation of Chronic Bronchitis
• Intervention / Treatment: Drug: andrographolide sulfonate; Drug: andrographolide sulfonate simulation

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.

• Study Type: Interventional
• Enrollment (Anticipated): 240
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Jiangxi
    • Nanchang, Jiangxi, China, 330029
      • Recruiting
      • The First Affiliated Hospital of Nanchang University

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:

• 1.18-75 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Experimental group; Conventional Therapy + Xiyanping injection(andrographolide sulfonate)	Drug: andrographolide sulfonate; Conventional Therapy+Xiyanping injection; Other Names: Xiyanping injection
PLACEBO_COMPARATOR: control group; Conventional Therapy + Xiyanping injection simulation/andrographolide sulfonate simulation(0.9% normal saline)	Drug: andrographolide sulfonate simulation; Conventional Therapy+Xiyanping injection simulation; Other Names: Xiyanping injection simulation

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Jiangxi Qingfeng Pharmaceutical Co. Ltd.
• Investigators: Principal Investigator: Ping Xu, The Fourth Affiliated Hospital of Nanchang University

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2016
• Primary Completion (ANTICIPATED): December 1, 2017
• Study Completion (ANTICIPATED): June 1, 2018

Study Registration Dates

• First Submitted: April 13, 2017
• First Submitted That Met QC Criteria: April 26, 2017
• First Posted (ACTUAL): April 28, 2017

Study Record Updates

• Last Update Posted (ACTUAL): April 28, 2017
• Last Update Submitted That Met QC Criteria: April 26, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Bronchial Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Acute Disease; Bronchitis; Bronchitis, Chronic; Physiological Effects of Drugs; Anti-Infective Agents; Peripheral Nervous System Agents; Antiviral Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Platelet Aggregation Inhibitors; Antiprotozoal Agents; Antiparasitic Agents; Andrographolide
• Other Study ID Numbers: JXQF-XYP-1608

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED