Acute Exacerbation of Chronic BronchitisPhase 2NCT01979926
Comparative Evaluate the Efficacy to Acute and Chronic Bronchitis
A Phase 2 study testing Combination of Broussonetia spp and Lonicera spp in people with Acute Exacerbation of Chronic Bronchitis, run by PharmaKing at 1 site in South Korea.
Trial summary
The Purpose of A Multicenter, Randomized, Double-blind, Placebo-controlled to Evaluate the Efficacy, Safety and Pharmacokinetics of N02RS1 600mg and 1,200mg per day in Patients With acute and acute exacerbation of chronic bronchitis for 7 days. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Acute Exacerbation of Chronic Bronchitis
- What is being tested?
- Combination of Broussonetia spp and Lonicera spp
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2013to Mar 2014
- Phase
- Phase 2
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over 18, under 75 years of age
- Patients Acute and Chronic Bronchitis
Who cannot join
- Patients who have gotten a glucocorticoids treatment within 4 weeks.
- Patients who need treatments of antibiotic and acute bronchitis infection.
- Patients who have gotten teatments of antibiotic,bronchodilator,painkiller and secretagog within 7 days.
- Bronchial asthma patient.
- Patients who have an indication of bleeding.
- Patients who have a serious heart and renal disease or liver ailment or immunosuppressive response.
- Patients who have history of over 3 phage of Chronic obstructiv lung disease
- Bronchiectasis patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double-blind, A Multicenter, Randomized, Placebo-controlled, Parallel, Phase 2 Study to Comparative Evaluate the Efficacy of N02RS1 600mg/Day, 12,00mg/Day in Korean Patients With Acute and Chronic Bronchitis
The Purpose of A Multicenter, Randomized, Double-blind, Placebo-controlled to Evaluate the Efficacy, Safety and Pharmacokinetics of N02RS1 600mg and 1,200mg per day in Patients With acute and acute exacerbation of chronic bronchitis for 7 days.
- Conditions
- Acute Exacerbation of Chronic Bronchitis
- Being tested
- Combination of Broussonetia spp and Lonicera spp
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combination of Broussonetia spp and Lonicera sppDrug
Also called N02RS1
600 mg/ day or 1200 mg/ day for 7 days
| Study group | Role | What they receive |
|---|---|---|
| N02RS1 200mg | Experimental | Combination of Broussonetia spp and Lonicera spp Receives: Drug: Combination of Broussonetia spp and Lonicera spp |
| N02RS1 400mg | Experimental | Combination of Broussonetia spp and Lonicera spp Receives: Drug: Combination of Broussonetia spp and Lonicera spp |
| Placebo | Placebo comparator | Sugar pill Receives: Drug: Combination of Broussonetia spp and Lonicera spp |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
1.Adverse Event: symptom, start day and time, end day and time, injection time, severity, progress, outcome, relation with investigational product.
Measured: 12weeks
Secondary outcomes (1)
Efficacy
- Before and after physical examination
- Before and after bital Sign: blood pressure, pulse rate, temperature.
- Before and after Lanza Score at the duodenum and stomach
- Lab: hematologic examination, blood coagulation examination,urine examination
- Cumulative incidence rate of an endoscopic peptic ulcer.
Measured: 12weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionNov 2013
- Study completionMar 2014
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- PharmaKing
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wayne B An, Bs, Study director, Korea Pharmaceutical Manufacturers Association
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01979926
- Sponsor's protocol ID
- PMK-N02RS1
- Status last verified
- May 2014
- First submitted
- 31 Oct 2013
- Last updated
- 30 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, A Multicenter, Randomized, Placebo-controlled, Parallel, Phase 2 Study to Comparative Evaluate the Efficacy of N02RS1 600mg/Day, 12,00mg/Day in Korean Patients With Acute and Chronic Bronchitis
- ClinicalTrials.gov ID
- NCT01979926
- Acronym / sponsor ID
- PMK-N02RS1
- Conditions
- Acute Exacerbation of Chronic Bronchitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- PharmaKingIndustry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 8 Nov 2013 (estimated)
- 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.
The Purpose of A Multicenter, Randomized, Double-blind, Placebo-controlled to Evaluate the Efficacy, Safety and Pharmacokinetics of N02RS1 600mg and 1,200mg per day in Patients With acute and acute exacerbation of chronic bronchitis for 7 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| N02RS1 200mg | Experimental | Drug: Combination of Broussonetia spp and Lonicera sppCombination of Broussonetia spp and Lonicera spp |
| N02RS1 400mg | Experimental | Drug: Combination of Broussonetia spp and Lonicera sppCombination of Broussonetia spp and Lonicera spp |
| Placebo | Placebo comparator | Drug: Combination of Broussonetia spp and Lonicera sppSugar pill |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients over 18, under 75 years of age
- Patients Acute and Chronic Bronchitis
Key exclusion criteria (8 listed)
- Patients who have gotten a glucocorticoids treatment within 4 weeks.
- Patients who need treatments of antibiotic and acute bronchitis infection.
- Patients who have gotten teatments of antibiotic,bronchodilator,painkiller and secretagog within 7 days.
- Bronchial asthma patient.
- Patients who have an indication of bleeding.
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 |
|---|---|---|
| Combination of Broussonetia spp and Lonicera sppAlso: N02RS1600 mg/ day or 1200 mg/ day for 7 days | Drug | N02RS1 200mg, N02RS1 400mg, Placebo |
Primary outcome
Safety
Time frame: 12weeks
1.Adverse Event: symptom, start day and time, end day and time, injection time, severity, progress, outcome, relation with investigational product.
1 secondary outcome
Efficacy
Time frame: 12weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2014.
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.
Wayne B An, Bs study director
Korea Pharmaceutical Manufacturers Association
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Combination of Broussonetia spp and Lonicera spp in people with Acute Exacerbation of Chronic Bronchitis, run by PharmaKing at 1 site in South Korea.
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 2 inclusion and 8 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: finished, as of the sponsor's last update on 30 May 2014. 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 South Korea. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (time frame: 12weeks). 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 30 May 2014.