Acute BronchitisPhase 3NCT02151734
Safety and Efficacy of KALOMIN™ Tab. in Patients With Acute Bronchitis
A Phase 3 study testing KALOMIN™ Tab. and Umckamin syrup in people with Acute Bronchitis, run by Korea United Pharm. Inc..
Trial summary
This is a multi-center, double-dummy, double-blind, randomized, active-controlled, parallel group phase 3 clinical trial to evaluate the efficacy and safety of KALOMIN™ Tab. in patients with acute bronchitis. The aim of this clinical trial is to demonstrate that KALOMIN™ Tab. Read more about this study
- Who is it for?
- Ages 12 to 75 years
- Conditions the study is for
- Acute Bronchitis
- What is being tested?
- KALOMIN™ Tab. and Umckamin syrup
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 242 participants
- Where
- No sites listed yet
- Study dates
- Aug 2013to Dec 2013
- Phase
- Phase 3
- 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 12 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male or female patients aged 12-75 years old
- A total score of BSS ≥ 5
- The duration of symptoms had to be less than 14 days and no chronic pulmonary disease
- Patients who voluntarily sign a written informed consent to participate in the trial
Who cannot join
- Indication for antibiotic treatment(e.g. severe respiratory infection)
- Allergic bronchial asthma
- Tendency to bleed
- Severe heart, renal, or liver diseases or decline of immune function
- Chronic obstructive pulmonary disease
- Known or supposed hypersensitivity to investigational medication
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- Treatment with antibiotics during the past 4 weeks prior to inclusion in the trial
- Women during pregnancy or lactation period
- Clinically significant abnormal values in the screening test(more than twice the upper limit of normal range for ALT, AST, BUN, and Serum Creatinine)
- Participation in any other trial within 30 days prior to inclusion in the trial
- Unsuitable patients for enrollment in the opinion of the investigator
About this study
This is a multi-center, double-dummy, double-blind, randomized, active-controlled, parallel group phase 3 clinical trial to evaluate the efficacy and safety of KALOMIN™ Tab. in patients with acute bronchitis.
The aim of this clinical trial is to demonstrate that KALOMIN™ Tab. is clinically non-inferior to Umckamin syrup, as assessed by BSS(Bronchitis Severity Score), in the treatment of acute bronchitis after 7 days.
- Conditions
- Acute Bronchitis
- Being tested
- KALOMIN™ Tab., Umckamin syrup
- Medical subject headings
- Bronchitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KALOMIN™ Tab.Drug
Umckamin syrupDrug
| Study group | Role | What they receive |
|---|---|---|
| KALOMIN™ Tab. | Experimental | KALOMIN™ Tab./Placebo to Umckamin syrup Receives: Drug: KALOMIN™ Tab. |
| Umckamin syrup | Active comparator | Umckamin syrup/Placebo to KALOMIN™ Tab. Receives: Drug: Umckamin syrup |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total score of BSS(Bronchitis Severity Score)
Measured: 7days
Secondary outcomes (5)
Individual symptom score of BSS
Measured: 7days
reaction rate of treatment
Measured: 7days
IMOS(Integrative Medicine Outcome Scale)
Measured: 7days
IMPSS(Integrative Medicine Patient Satisfaction Scale)
Measured: 7days
Adverse events, clinical laboratory examination, physical examination, etc.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2014 (estimated)
- Study startAug 2013
- Primary completionDec 2013
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea United Pharm. Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02151734
- Sponsor's protocol ID
- KUP-KLM_301
- Status last verified
- May 2014
- First submitted
- 28 May 2014
- Last updated
- 30 May 2014
- Results posted
- No
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
- Safety and Efficacy of KALOMIN™ Tab. in Patients With Acute Bronchitis
- ClinicalTrials.gov ID
- NCT02151734
- Acronym / sponsor ID
- KUP-KLM_301
- Conditions
- Acute Bronchitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- Korea United Pharm. Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- Dec 2013 (actual)
- First posted
- 30 May 2014 (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.
This is a multi-center, double-dummy, double-blind, randomized, active-controlled, parallel group phase 3 clinical trial to evaluate the efficacy and safety of KALOMIN™ Tab. in patients with acute bronchitis.
The aim of this clinical trial is to demonstrate that KALOMIN™ Tab. is clinically non-inferior to Umckamin syrup, as assessed by BSS(Bronchitis Severity Score), in the treatment of acute bronchitis after 7 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KALOMIN™ Tab. | Experimental | Drug: KALOMIN™ Tab.KALOMIN™ Tab./Placebo to Umckamin syrup |
| Umckamin syrup | Active comparator | Drug: Umckamin syrupUmckamin syrup/Placebo to KALOMIN™ Tab. |
Who may qualify
- Ages
- 12 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female patients aged 12-75 years old
- A total score of BSS ≥ 5
- The duration of symptoms had to be less than 14 days and no chronic pulmonary disease
- Patients who voluntarily sign a written informed consent to participate in the trial
Key exclusion criteria (11 listed)
- Indication for antibiotic treatment(e.g. severe respiratory infection)
- Allergic bronchial asthma
- Tendency to bleed
- Severe heart, renal, or liver diseases or decline of immune function
- 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 |
|---|---|---|
| KALOMIN™ Tab. | Drug | KALOMIN™ Tab. |
| Umckamin syrup | Drug | Umckamin syrup |
Primary outcome
Total score of BSS(Bronchitis Severity Score)
Time frame: 7days
5 secondary outcomes
Individual symptom score of BSS
Time frame: 7days
reaction rate of treatment
Time frame: 7days
IMOS(Integrative Medicine Outcome Scale)
Time frame: 7days
IMPSS(Integrative Medicine Patient Satisfaction Scale)
Time frame: 7days
Adverse events, clinical laboratory examination, physical examination, etc.
Time frame: 7 days
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.
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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 3 study testing KALOMIN™ Tab. and Umckamin syrup in people with Acute Bronchitis, run by Korea United Pharm. Inc..
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 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 May 2014. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Total score of BSS(Bronchitis Severity Score) (time frame: 7days). 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.