Acute Exacerbation of Chronic BronchitisPhase 4NCT03132610
A Study of Andrographolide Sulfonate in Patients With Acute Exacerbation of Chronic Bronchitis
A Phase 4 study testing andrographolide sulfonate and andrographolide sulfonate simulation in people with Acute Exacerbation of Chronic Bronchitis, run by Jiangxi Qingfeng Pharmaceutical Co. Ltd. at 1 site in China.
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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Exacerbation of Chronic Bronchitis
- What is being tested?
- andrographolide sulfonate and andrographolide sulfonate simulation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2016to 1 Jun 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330029
Wei Zhang, +86 0790-88694316
About this study
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
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
Read the 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.
- Conditions
- Acute Exacerbation of Chronic Bronchitis
- Being tested
- andrographolide sulfonate, andrographolide sulfonate simulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
andrographolide sulfonateDrug
Also called Xiyanping injection
Conventional Therapy+Xiyanping injection
andrographolide sulfonate simulationDrug
Also called Xiyanping injection simulation
Conventional Therapy+Xiyanping injection simulation
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Active comparator | Conventional Therapy + Xiyanping injection(andrographolide sulfonate) Receives: Drug: andrographolide sulfonate |
| control group | Placebo comparator | Conventional Therapy + Xiyanping injection simulation/andrographolide sulfonate simulation(0.9% normal saline) Receives: Drug: andrographolide sulfonate simulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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。
Measured: less than 14 days
Secondary outcomes (6)
effective time window
days range from treatment is received to the effectiveness is observed, and symptoms disappear (fever, cough, expectoration and gasp).
Measured: less than 14 days
days of antibiotic use
oral anti infective drugs use days and intravenous anti infective drugs use days are recorded
Measured: 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.
Measured: 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%
Measured: less than 14 days
direct medical cost
medical cost including hospital expenses, examine fee, medication fee, et al, relate to treatment in hospital
Measured: 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.
Measured: less than 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2017
- Study start1 Dec 2016
- Primary completion1 Dec 2017 (estimated)
- Study completion1 Jun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Exacerbation of Chronic BronchitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangxi Qingfeng Pharmaceutical Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wei Zhang, Principal investigator, The First Affiliated Hospital of Nanchang UniversityPing Xu, Principal investigator, The Fourth Affiliated Hospital of Nanchang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03132610
- Sponsor's protocol ID
- JXQF-XYP-1608
- Status last verified
- Apr 2017
- First submitted
- 13 Apr 2017
- Last updated
- 28 Apr 2017
- Results posted
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03132610
- Acronym / sponsor ID
- JXQF-XYP-1608
- Conditions
- Acute Exacerbation of Chronic Bronchitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Jiangxi Qingfeng Pharmaceutical Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 1 Dec 2017 (estimated)
- Study completion
- 1 Jun 2018 (estimated)
- First posted
- 28 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Active comparator | Drug: andrographolide sulfonateConventional Therapy + Xiyanping injection(andrographolide sulfonate) |
| control group | Placebo comparator | Drug: andrographolide sulfonate simulationConventional Therapy + Xiyanping injection simulation/andrographolide sulfonate simulation(0.9% normal saline) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| andrographolide sulfonateAlso: Xiyanping injectionConventional Therapy+Xiyanping injection | Drug | Experimental group |
| andrographolide sulfonate simulationAlso: Xiyanping injection simulationConventional Therapy+Xiyanping injection simulation | Drug | control group |
Primary outcome
cured rate
Time frame: less than 14 days
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。
6 secondary outcomes
effective time window
Time frame: less than 14 days
days of antibiotic use
Time frame: less than 14 days
the incidence of complications
Time frame: less than 14 days
bacterial eradication rate
Time frame: less than 14 days
direct medical cost
Time frame: less than 14 days
number of participants with treatment-related adverse events
Time frame: less than 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Acute Exacerbation of Chronic Bronchitis
Enrolling by invitationObservational study
The Italian Registry of Patients With Chronic Obstructive Pulmonary Disease
COPD, COPD Exacerbation Acute
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wei Zhang principal investigator
The First Affiliated Hospital of Nanchang University
Ping Xu principal investigator
The Fourth Affiliated Hospital of Nanchang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing andrographolide sulfonate and andrographolide sulfonate simulation in people with Acute Exacerbation of Chronic Bronchitis, run by Jiangxi Qingfeng Pharmaceutical Co. Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lang Lv (+86 010-84682600, bjlll@qfyy.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cured rate (time frame: less than 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2017.