Acute BronchitisPhase 3NCT01416480
Clinical Trial to Evaluate the Safety and Efficacy of "Theobromine Capsule" as an Antitussive in Acute Cougher
A Phase 3 study testing Theobromine 300mg and Levodropropizine 10mg in people with Acute Bronchitis, run by Ahn-Gook Pharmaceuticals Co.,Ltd at 1 site in South Korea.
Trial summary
The aim of this clinical trial is to evaluate the antitussive effect of "Theobromine capsule 300mg" in patients with acute bronchitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Bronchitis
- What is being tested?
- Theobromine 300mg and Levodropropizine 10mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 332 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2010to May 2011
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient who decided to participate in this clinical trial at his(her) own will and agreed in written letter of consent.
- Adult aged over 18
- Patient who has cough symptom caused by acute bronchitis
- Patient who go to see the doctor for severe cough at his(her) own will
- DCS score at screening vist sould be over 3.
- For fertile woman, HCG test at screening visit shloud be negative.
- patient who will continue to cough more than 1 week.(by physician's judgment)
Who cannot join
- Patient who is accompanied by the seriously abnormal symptom in respiratory system, such as Acute infectious Pulmonary Disease, Tuberculosis, asthma.
- Chronic bronchitis including bronchial obstruction
- Patient who has clinical history of sensitivity to Xanthine drug.
- Patient who has Peptic Ulcer
- Patient whose liver or kidney function is seriously abnormal: Including the cases of sGOT, sGPT, bilirubin and blood creatinine value exceeding twice of their upper normal limit.
- Patient whose heart function is abnormal: including the case of showing abnormal EKG test value that is clinically significant.
Show all 10Show fewer
- patient who has convulsion or alcoholism.
- Patient who has experience to have participated in other clinical trial within two months before starting the trial.
- Pregnant woman, lactating woman.
- Patient who thought to be cured within 3 days without any medicine.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Hallym University Medical Center
Anyang-si, Gyeonggi-do, 431-070
About this study
Official title: Therapeutic Confirmatory Clinical Trial to Evaluate the Safety and Efficacy of "Theobromine Capsule 300mg" as an Antitussive Agent in Acute Cough Patients.
The aim of this clinical trial is to evaluate the antitussive effect of "Theobromine capsule 300mg" in patients with acute bronchitis.
Read the detailed description
This study is double blinded, randomized, parallel designed, phase III clinical trial to evaluate the efficacy and safety of "Theobromine capsule 300mg" versus "Levodropropizine syrup" in patients with acute bronchitis.
- Conditions
- Acute Bronchitis
- Being tested
- Theobromine 300mg, Levodropropizine 10mg
- Keywords
- Theobromine, cough, acute bronchitis
- Medical subject headings
- Bronchitis, Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Theobromine 300mgDrug
Capsule, b.i.d.
Levodropropizine 10mgDrug
Syrup, t.i.d.
| Study group | Role | What they receive |
|---|---|---|
| Theobromine | Experimental | Theobromine capsule 300mg Receives: Drug: Theobromine 300mg |
| levodropropizine | Active comparator | levodropropizine syrup Receives: Drug: Levodropropizine 10mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
cough remission rate
cough remission : no cough or 1 short cough in day time
Measured: 3 days
Secondary outcomes (3)
cough recovery rate
Measured: 1 day, 2 days, within 3days
difference of DCS score between screening and closing visit.
Measured: 3 days
required time for cough remission
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2011 (estimated)
- Study startMay 2010
- Primary completionFeb 2011
- Study completionMay 2011
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 332 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahn-Gook Pharmaceuticals Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Ki-Suck Jung, M.D., Principal investigator, Hallym University Medical CenterSoo-Taek Uh, M.D., Principal investigator, Soonchunhyang University HospitalJae Yeol Kim, M.D., Principal investigator, Chung-Ang University Medical CenterYoung Kyoon Kim, M.D., Principal investigator, The Catholic University of Korea-St. Mary's HospitalSung Soon Lee, M.D., Principal investigator, Inje University Ilsan Paik HospitalYong Bum Park, M.D., Principal investigator, Kangdong Sacred Heart HospitalKwan Ho Lee, M.D., Principal investigator, Yeungnam University HospitalJung Hyun chang, M.D., Principal investigator, Ewha Womans University Mokdong Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01416480
- Sponsor's protocol ID
- AG1321001_ACP3
- Status last verified
- Aug 2011
- First submitted
- 12 Aug 2011
- Last updated
- 15 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Confirmatory Clinical Trial to Evaluate the Safety and Efficacy of "Theobromine Capsule 300mg" as an Antitussive Agent in Acute Cough Patients.
- ClinicalTrials.gov ID
- NCT01416480
- Acronym / sponsor ID
- AG1321001_ACP3
- Conditions
- Acute Bronchitis
- Keywords
- Theobromine, cough, acute bronchitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 332 participants (actual)
- Lead sponsor
- Ahn-Gook Pharmaceuticals Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 15 Aug 2011 (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 aim of this clinical trial is to evaluate the antitussive effect of "Theobromine capsule 300mg" in patients with acute bronchitis.
Detailed description
This study is double blinded, randomized, parallel designed, phase III clinical trial to evaluate the efficacy and safety of "Theobromine capsule 300mg" versus "Levodropropizine syrup" in patients with acute bronchitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Theobromine | Experimental | Drug: Theobromine 300mgTheobromine capsule 300mg |
| levodropropizine | Active comparator | Drug: Levodropropizine 10mglevodropropizine syrup |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient who decided to participate in this clinical trial at his(her) own will and agreed in written letter of consent.
- Adult aged over 18
- Patient who has cough symptom caused by acute bronchitis
- Patient who go to see the doctor for severe cough at his(her) own will
- DCS score at screening vist sould be over 3.
Key exclusion criteria (10 listed)
- Patient who is accompanied by the seriously abnormal symptom in respiratory system, such as Acute infectious Pulmonary Disease, Tuberculosis, asthma.
- Chronic bronchitis including bronchial obstruction
- Patient who has clinical history of sensitivity to Xanthine drug.
- Patient who has Peptic Ulcer
- Patient whose liver or kidney function is seriously abnormal: Including the cases of sGOT, sGPT, bilirubin and blood creatinine value exceeding twice of their upper normal limit.
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 |
|---|---|---|
| Theobromine 300mgCapsule, b.i.d. | Drug | Theobromine |
| Levodropropizine 10mgSyrup, t.i.d. | Drug | levodropropizine |
Primary outcome
cough remission rate
Time frame: 3 days
cough remission : no cough or 1 short cough in day time
3 secondary outcomes
cough recovery rate
Time frame: 1 day, 2 days, within 3days
difference of DCS score between screening and closing visit.
Time frame: 3 days
required time for cough remission
Time frame: 3 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 15 Aug 2011.
Related trials for Acute Bronchitis
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Active, not recruiting
Respiratory Support and Treatment for Efficient and Cost-Effective Care
Bronchiolitis
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease
RecruitingPhase 2
A Study of 24 to 52 Weeks Treatment to Evaluate The Efficacy And Safety of Galvokimig in Study Participants With Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD) With Chronic Bronchitis
Chronic Obstructive Pulmonary Disease With Chronic Bronchitis
Not yet recruiting
Influence of Patient Positioning During Nasal Lavage
Acute Upper Respiratory Tract Infections, Nasal Obstruction
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.
Ki-Suck Jung, M.D. principal investigator
Hallym University Medical Center
Soo-Taek Uh, M.D. principal investigator
Soonchunhyang University Hospital
Jae Yeol Kim, M.D. principal investigator
Chung-Ang University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Theobromine 300mg and Levodropropizine 10mg in people with Acute Bronchitis, run by Ahn-Gook Pharmaceuticals Co.,Ltd 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 7 inclusion and 10 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 15 Aug 2011. 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. 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?
cough remission rate (time frame: 3 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 15 Aug 2011.