Acute BronchitisPhase 3NCT02792946
Compare the Efficacy and Safety of Surfolase CR Tablet With Surfolase Capsule in Patients With Acute Bronchitis
A Phase 3 study testing Acebrophylline in people with Acute Bronchitis, run by Hyundai Pharmaceutical Co., LTD..
Trial summary
Compare the efficacy and safety of surfolase CR tablet with surfolate capsule in patients with acute bronchitis Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Acute Bronchitis
- What is being tested?
- Acebrophylline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 244 participants
- Where
- No sites listed yet
- Study dates
- Nov 2015to Jan 2016
- 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 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged 19 to 65 years, inclusive
- Patients with acute bronchitis which is accompanied with a cough which includes sputum within 48 hours and has over 5 for Bronchitis severity score (BSS) at Screening
- Patients who agreed to participate clinical trial and sign on informed consent form
Who cannot join
- Patients who are suspicious or diagnosed for pneumonia
- Patients with chronic bronchitis, Chronic Obstructive Pulmonary Disease (COPD), bronchiolitis, asthma, bronchial asthma
- Patients with active infection who needs administration of antibiotics
- Patients with myocardial infarction, congestive heart failure
- Patients with renal disorder or liver disorder
- Patients with hypotension or hypertension
Show all 20Show fewer
- Patients with history of epilepsy
- Patients with hyperthyroidism
- Patients with gastroduodenal ulcer
- Patients with sever hypoxemia
- Patients who are in drug or therapy or planned to have;
- antibiotics, anti-virus, angiotensin converting enzyme (ACE) inhibitor and systemic or inhalation glucocorticosteroids: from 2 weeks prior to administration of investigational product to termination of clinical trial
- Angiotension II receptor blocker (ARB), secretolytics/mucolytics, expectorants, antitussives, a herb medicines which has antitussive or expectorant effect: from 2 days prior to administration of investigational product to termination of clinical trial
- Analgesics except acetaminophen, antihistamines, β2-agonists, bronchodilators which includes anticholinergic agents, xanthine derivatives, central nervous system stimulants, drug which is known for interaction between acebrophylline (cimetidine, alloprinol, oral anticoagulants, furosemide, reserpine, barbiturates, phenytoin) and symtomatic therapy for other therapy for acute bronchitis: whole period for clinical trial
- Smokers
- Patients who has history for drug hypersensitivity or allergic reaction in component of investigational product or similar drug
- Patients with pregnant and/or have breast feeding.
- Patients with no intention to use appropriate contraceptives or has a plan to become pregnant
- Patients who had an administrationb of other investigational product or medical device for clinical trial 4 weeks prior to participation of clinical trial
- Patients who are identified as inappropriate by other investigators to participate clinical trial
About this study
Compare the efficacy and safety of surfolase CR tablet with surfolate capsule in patients with acute bronchitis
- Conditions
- Acute Bronchitis
- Being tested
- Acebrophylline
- Medical subject headings
- Bronchitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcebrophyllineDrug
| Study group | Role | What they receive |
|---|---|---|
| Sulfolase CR (200mg, QD) | Experimental | for 7 days with or without meal Receives: Drug: Acebrophylline |
| Sulfolase Capsule (100mg, BID) | Active comparator | for 7 days with or without meal Receives: Drug: Acebrophylline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in baseline to Day 7 for total number of Bronchitis Severity Score (BSS)
Measured: Baseline, At Day 7
Secondary outcomes (2)
Change from Baseline in baseline to Day 7 for number of BSS per symptom
Measured: Baseline, At Day 7
Response rate at Day 7
Measured: Baseline, At Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2016 (estimated)
- Study startNov 2015
- Primary completionJan 2016
- Study completionJan 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 244 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hyundai Pharmaceutical Co., LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02792946
- Sponsor's protocol ID
- HT-002-05
- Status last verified
- Jun 2016
- First submitted
- 3 Jun 2016
- Last updated
- 16 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compare the Efficacy and Safety of Surfolase CR Tablet With Surfolase Capsule in Patients With Acute Bronchitis
- ClinicalTrials.gov ID
- NCT02792946
- Acronym / sponsor ID
- HT-002-05
- Conditions
- Acute Bronchitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 244 participants (actual)
- Lead sponsor
- Hyundai Pharmaceutical Co., LTD.Industry (pharma, biotech, devices)
- Study start
- Nov 2015 (actual)
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 8 Jun 2016 (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.
Compare the efficacy and safety of surfolase CR tablet with surfolate capsule in patients with acute bronchitis
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 |
|---|---|---|
| Sulfolase CR (200mg, QD) | Experimental | Drug: Acebrophyllinefor 7 days with or without meal |
| Sulfolase Capsule (100mg, BID) | Active comparator | Drug: Acebrophyllinefor 7 days with or without meal |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female aged 19 to 65 years, inclusive
- Patients with acute bronchitis which is accompanied with a cough which includes sputum within 48 hours and has over 5 for Bronchitis severity score (BSS) at Screening
- Patients who agreed to participate clinical trial and sign on informed consent form
Key exclusion criteria (20 listed)
- Patients who are suspicious or diagnosed for pneumonia
- Patients with chronic bronchitis, Chronic Obstructive Pulmonary Disease (COPD), bronchiolitis, asthma, bronchial asthma
- Patients with active infection who needs administration of antibiotics
- Patients with myocardial infarction, congestive heart failure
- Patients with renal disorder or liver disorder
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 |
|---|---|---|
| Acebrophylline | Drug | Sulfolase CR (200mg, QD), Sulfolase Capsule (100mg, BID) |
Primary outcome
Change from Baseline in baseline to Day 7 for total number of Bronchitis Severity Score (BSS)
Time frame: Baseline, At Day 7
2 secondary outcomes
Change from Baseline in baseline to Day 7 for number of BSS per symptom
Time frame: Baseline, At Day 7
Response rate at Day 7
Time frame: Baseline, At Day 7
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 16 Jun 2017.
- Individual participant dataSharing planned: No
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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 Acebrophylline in people with Acute Bronchitis, run by Hyundai Pharmaceutical Co., LTD..
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 3 inclusion and 20 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 16 Jun 2017. 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?
Change from Baseline in baseline to Day 7 for total number of Bronchitis Severity Score (BSS) (time frame: Baseline, At Day 7). 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 16 Jun 2017.