Acute BronchitisPhase 2NCT02637310
Evaluate the Efficacy and Safety of N02RS1 in Patient With Acute Bronchitis
A Phase 2 study testing N02RS1 1200mg in people with Acute Bronchitis, run by PharmaKing.
Trial summary
A multi center, randomized, double-blind, placebo-controlled, parallel, phase 2b clinical trial to evaluate the efficacy and safety of N02RS1 in patients with acute bronchitis Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Acute Bronchitis
- What is being tested?
- N02RS1 1200mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- No sites listed yet
- Study dates
- Dec 2015to Mar 2016
- 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 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over 19, under 75 of age
- Patients acute bronchitis, sputum symptoms, BSS over 7 points.
- Patients acute bronchitis within 7days.
- Non-pregnant, patients who agree to contraception.
- Patients who can write diary and available to communicate.
- Patients voluntarily agreed
Who cannot join
- Patients with hypersensitivity to the drug.
- Patients who have gotten systemic steroid treatment within 4 weeks.
- Patients who have gotten treatment of antibiotics, bronchodilators, painkiller and secretagog within 7 days.
- Patients who have gotten treatment of mucus solvents or antitussives within 3 days.
- Patients who serious respiratory infections requiring antibiotic treatment, allergic bronchial asthma, bronchiectasis and chronic obstructive pulmonary disease.
- Patients heart disease, severe kidney, liver disease.
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- The bleeding tendency or immunosuppressed patients.
- Patients with clinically significant abnormal values.
- Pregnant women or nursing mothers.
- Patients alcoholics or drug abuse.
- Patients taking other clinical trail's medicines within 30 days.
About this study
Official title: A Multi Center, Randomized, Double-blind, Placebo-controlled, Parallel, Phase 2b Clinical Trial to Evaluate the Efficacy and Safety of N02RS1 in Patients With Acute Bronchitis
A multi center, randomized, double-blind, placebo-controlled, parallel, phase 2b clinical trial to evaluate the efficacy and safety of N02RS1 in patients with acute bronchitis
Read the detailed description
Suitable subjects randomized to the experimental or control group. The subjects eat IP during 7days. Visit 3(3 days) evaluate BSS through phone call and visit 4(8 days) evaluate efficacy and safety.
- Conditions
- Acute Bronchitis
- Being tested
- N02RS1 1200mg, Placebo
- Medical subject headings
- Bronchitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N02RS1 1200mgDrug
1200mg/day, Three times a day orally, 2 tablets once, 7 days
PlaceboDrug
1200mg/day, Three times a day orally, 2 tablets once, 7 days
| Study group | Role | What they receive |
|---|---|---|
| N02RS1 1200mg | Experimental | Combination of Broussonetia spp and Lonicera spp Receives: Drug: N02RS1 1200mg |
| Placebo | Placebo comparator | sugar pill Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
BSS(Bronchitis Severity Score) score variation compared to baseline after 7 days
Measured: Visit 1(-3days, screening), 2(0day, randomization), 3(3days), 4(8days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- PharmaKing
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02637310
- Sponsor's protocol ID
- PMK-N02RS1_Phase 2B
- Status last verified
- Mar 2016
- First submitted
- 8 Dec 2015
- Last updated
- 30 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi Center, Randomized, Double-blind, Placebo-controlled, Parallel, Phase 2b Clinical Trial to Evaluate the Efficacy and Safety of N02RS1 in Patients With Acute Bronchitis
- ClinicalTrials.gov ID
- NCT02637310
- Acronym / sponsor ID
- PMK-N02RS1_Phase 2B
- Conditions
- Acute Bronchitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- PharmaKingIndustry (pharma, biotech, devices)
- Study start
- Dec 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 22 Dec 2015 (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.
A multi center, randomized, double-blind, placebo-controlled, parallel, phase 2b clinical trial to evaluate the efficacy and safety of N02RS1 in patients with acute bronchitis
Detailed description
Suitable subjects randomized to the experimental or control group. The subjects eat IP during 7days. Visit 3(3 days) evaluate BSS through phone call and visit 4(8 days) evaluate efficacy and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| N02RS1 1200mg | Experimental | Drug: N02RS1 1200mgCombination of Broussonetia spp and Lonicera spp |
| Placebo | Placebo comparator | Drug: Placebosugar pill |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients over 19, under 75 of age
- Patients acute bronchitis, sputum symptoms, BSS over 7 points.
- Patients acute bronchitis within 7days.
- Non-pregnant, patients who agree to contraception.
- Patients who can write diary and available to communicate.
Key exclusion criteria (11 listed)
- Patients with hypersensitivity to the drug.
- Patients who have gotten systemic steroid treatment within 4 weeks.
- Patients who have gotten treatment of antibiotics, bronchodilators, painkiller and secretagog within 7 days.
- Patients who have gotten treatment of mucus solvents or antitussives within 3 days.
- Patients who serious respiratory infections requiring antibiotic treatment, allergic bronchial asthma, bronchiectasis and chronic obstructive pulmonary disease.
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 |
|---|---|---|
| N02RS1 1200mg1200mg/day, Three times a day orally, 2 tablets once, 7 days | Drug | N02RS1 1200mg |
| Placebo1200mg/day, Three times a day orally, 2 tablets once, 7 days | Drug | Placebo |
Primary outcome
BSS(Bronchitis Severity Score) score variation compared to baseline after 7 days
Time frame: Visit 1(-3days, screening), 2(0day, randomization), 3(3days), 4(8days)
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 Mar 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing N02RS1 1200mg in people with Acute Bronchitis, run by PharmaKing.
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 6 inclusion and 11 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 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
BSS(Bronchitis Severity Score) score variation compared to baseline after 7 days (time frame: Visit 1(-3days, screening), 2(0day, randomization), 3(3days), 4(8days)). 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 Mar 2016.