Bronchitis, COPDPhase 4NCT03623282
Study Regarding the Clinical Efficacy of Synatura® in Patients With Chronic Bronchitis Type COPD
A Phase 4 study testing Synatura® 15 mL in people with Bronchitis, COPD, run by Ahn-Gook Pharmaceuticals Co.,Ltd at 1 site in South Korea.
Trial summary
This study aims to examine the clinical efficacy of synatura in patients with chronic bronchitis type COPD in Korea. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Bronchitis, COPD
- What is being tested?
- Synatura® 15 mL
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 17 Apr 2017to 2 May 2018
- Phase
- Phase 4
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Post bronchodilator FEV1/FVC < 0.7
- Smoking history of ≥10 packs per year
- 40 to <75 years of age
- Patients with symptoms of chronic bronchitis (in case they have symptoms of cough or sputum over 3 months)
Who cannot join
- Patients with acute exacerbation
- Patients with pneumonia
- Patients with active tuberculosis
- Pregnant women
- Breast-feeding women
- Patients with fructose intolerance
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to examine the clinical efficacy of synatura in patients with chronic bronchitis type COPD in Korea.
Read the detailed description
Synatura® is a drug commonly used to suppress cough and sputum in patients with acute upper respiratory tract infection and chronic inflammatory bronchitis. According to the Phase III studies conducted in Korea, the safety and efficacy of Synatura® on antitussive and expectorant effects were confirmed in patients with acute upper respiratory infection and chronic inflammatory bronchitis. However, no studies have been conducted for the effects of Synatura® in patients with COPD. COPD is divided into emphysema type and chronic bronchitis type, while typical clinical symptoms of chronic bronchitis are cough and sputum. Therefore, Synatura®, which is effective for chronic bronchitis, is expected to be effective in patients with chronic bronchitis accompanied by COPD.
- Conditions
- Bronchitis, COPD
- Being tested
- Synatura® 15 mL
- Keywords
- Synatura, Chronic Obstructive Pulmonary Disease, Ahn Gook Pharmaceuticals
- Medical subject headings
- Bronchitis, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Synatura® 15 mLDrug
Also called AG NPP709
All subjects will receive Synatura® 15 mL every day three times for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Synatura® 15 mL | Experimental | Synatura syrup single arm Receives: Drug: Synatura® 15 mL |
What is being measured
The primary outcome is the main question the study is designed to answer.
COPD assessment test (CAT)
Change from Baseline in baseline to 12 weeks for COPD assessment test (CAT)
Measured: Baseline, At 12weeks
Secondary outcomes (3)
Efficacy of pulmonary function in bronchitis type COPD patients
Pulmonary function test will be performed before and 3 months after taking Synatura.
Assessment Tools: FVC (L), FVC (%), FEV1 (L), FEV1 (%), FEV1/FVC (%), TLC (%), RV (%), RV/TLC (%), DLCO (%), DLCO/VA (%)
Measured: Baseline, At 12weeks
Efficacy of inflammation throughout the body in bronchitis type COPD patients
Blood samples will be taken before and 3 months after taking Synatura, then stored and measured by ELISA in the laboratory.
Assessment Tools: CRP, Fibrinogen, IL-6, TNF-α
Measured: Baseline, At 12weeks
Total number of Bronchitis Severity Score (BSS)
Bronchitis Severity Score (BSS) will be performed before and 3 months after taking Synatura
The BSS measured cough, sputum, rales/ rhonchi, chest pain during coughing, and dyspnoea. Each of these features of acute bronchitis was scored by a welltrained doctor using a 5point Likert rating scale ranging from 0 to 4 (0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe)
The overall BSS will be graded as mild (0-7), moderate (8-14), and severe (15,20).
Measured: Baseline, At 12weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2018
- Study start17 Apr 2017
- Primary completion2 May 2018
- Study completion2 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchitis, COPDStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Experimental(Single arm): The enrolled patients will be prescribed Synatura® following measurement of pre-dose pulmonary functions, quality of life and systemic inflammatory state. Pulmonary functions, quality of life and systemic inflammatory state will be repeatedly measured after taking Synatura® for 3 months, and the changes from pre-dose measurements will be observed.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahn-Gook Pharmaceuticals Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chinkook Rhee, MD, Principal investigator, Seoul St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03623282
- Sponsor's protocol ID
- AG-SYN-01
- Status last verified
- Aug 2018
- First submitted
- 6 Aug 2018
- Last updated
- 10 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Regarding the Clinical Efficacy of Synatura® in Patients With Chronic Bronchitis Type COPD
- ClinicalTrials.gov ID
- NCT03623282
- Acronym / sponsor ID
- AG-SYN-01
- Conditions
- Bronchitis, COPD
- Keywords
- Synatura, Chronic Obstructive Pulmonary Disease, Ahn Gook Pharmaceuticals
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ahn-Gook Pharmaceuticals Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 17 Apr 2017 (actual)
- Primary completion
- 2 May 2018 (actual)
- Study completion
- 2 May 2018 (actual)
- First posted
- 9 Aug 2018 (actual)
- 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 study aims to examine the clinical efficacy of synatura in patients with chronic bronchitis type COPD in Korea.
Detailed description
Synatura® is a drug commonly used to suppress cough and sputum in patients with acute upper respiratory tract infection and chronic inflammatory bronchitis. According to the Phase III studies conducted in Korea, the safety and efficacy of Synatura® on antitussive and expectorant effects were confirmed in patients with acute upper respiratory infection and chronic inflammatory bronchitis. However, no studies have been conducted for the effects of Synatura® in patients with COPD. COPD is divided into emphysema type and chronic bronchitis type, while typical clinical symptoms of chronic bronchitis are cough and sputum. Therefore, Synatura®, which is effective for chronic bronchitis, is expected to be effective in patients with chronic bronchitis accompanied by COPD.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Experimental(Single arm): The enrolled patients will be prescribed Synatura® following measurement of pre-dose pulmonary functions, quality of life and systemic inflammatory state. Pulmonary functions, quality of life and systemic inflammatory state will be repeatedly measured after taking Synatura® for 3 months, and the changes from pre-dose measurements will be observed.
| Arm | Type | Receives |
|---|---|---|
| Synatura® 15 mL | Experimental | Drug: Synatura® 15 mLSynatura syrup single arm |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Post bronchodilator FEV1/FVC < 0.7
- Smoking history of ≥10 packs per year
- 40 to <75 years of age
- Patients with symptoms of chronic bronchitis (in case they have symptoms of cough or sputum over 3 months)
Key exclusion criteria (6 listed)
- Patients with acute exacerbation
- Patients with pneumonia
- Patients with active tuberculosis
- Pregnant women
- Breast-feeding women
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 |
|---|---|---|
| Synatura® 15 mLAlso: AG NPP709All subjects will receive Synatura® 15 mL every day three times for 3 months. | Drug | Synatura® 15 mL |
Primary outcome
COPD assessment test (CAT)
Time frame: Baseline, At 12weeks
Change from Baseline in baseline to 12 weeks for COPD assessment test (CAT)
3 secondary outcomes
Efficacy of pulmonary function in bronchitis type COPD patients
Time frame: Baseline, At 12weeks
Efficacy of inflammation throughout the body in bronchitis type COPD patients
Time frame: Baseline, At 12weeks
Total number of Bronchitis Severity Score (BSS)
Time frame: Baseline, At 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 10 Aug 2018.
- Individual participant dataSharing planned: No
Related trials for Bronchitis, COPD
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
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
Recruiting
Comparison of Several Oxygenation Targets With Different Oxygen Interfaces - Impact on Oxygen Flow Rates
Oxygen Toxicity, COPD Bronchitis
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Adult Participants With Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD)
Pulmonary Disease, Chronic Obstructive
RecruitingPhase 2
To Evaluate the Effect of EXPD-101/FXS7553 Compared With Placebo in Patients With COPD Over 52 Weeks of Treatment
Chronic Obstructive Pulmonary Disease (COPD)
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.
Chinkook Rhee, MD principal investigator
Seoul St. Mary's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Synatura® 15 mL in people with Bronchitis, COPD, 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 4 inclusion and 6 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 10 Aug 2018. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
COPD assessment test (CAT) (time frame: Baseline, At 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 10 Aug 2018.