Mild to Moderate Bronchial AsthmaPhase 2NCT01740986
Safety and Efficacy of SA09012 in Asthma
A Phase 2 study testing SA09012 Low dose and SA09012 High dose in people with Mild to Moderate Bronchial Asthma, run by SamA Pharmaceutical Co., Ltd at 14 sites in South Korea.
Trial summary
Clinical Study to Evaluate the Efficacy, Dose-response and Safety of SA09012 in Bronchial Asthma Patients Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- Mild to Moderate Bronchial Asthma
- What is being tested?
- SA09012 Low dose and SA09012 High dose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 225 participants
- Where
- 14 sitesSouth Korea
- Study dates
- Nov 2012to Nov 2015
- 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 20 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis or presence of asthma within 3 months of the prestudy visit
- Increase in PEF ≥ 20% or ≥ 60L/min from baseline value after taking Bronchodilator at screening or within the 3 months of the prestudy visit
- Increase in FEV1 ≥ 12% and ≥ 200mL from baseline value after taking Bronchodilator at screening or within the 3 months of the prestudy visit
- FEV1 or PEF between 60% and 85% of the predicted value at screening or within the 3 months of the prestudy visit
- Having signed an informed consent
Who cannot join
- Patient who has severe asthma
- Patient who has any significant medical condition that might compromise patient safety, interfere with evaluation or preclude completion of the study other protocol-defined inclusion/exclusion criteria may apply
- Patient with an AST or ALT > 2x ULN (upper limit of normal) in the screening visit
- Patient with more than 10 pack year of cigarettes history
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
South Korea14 sites
Chonbuk National University Hospital
Chonbuk
Chonnam National University Hospital
Gwangju
Ajou University Hospital
Gyeonggi-do
Bucheon St. Mary's Hospital, The Catholic University of Korea
Gyeonggi-do
Hallym University Sacred Heart Hospital
Gyeonggi-do
Soon Chun Hyang University Bucheon Hospital
Gyeonggi-do
Chungbuk National University Hospital
Jungbuk
Konkuk University Medical Center
Seoul
Korea University Guro Hospital
Seoul
KyungHee University Medical Center
Seoul
Seoul St. Mary's Hospital, The Catholic University of Korea
Seoul
Soonchunhyang University Hospital, Seoul
Seoul
St. Paul's Hospital, The Catholic University of Korea
Seoul
Yonsei University, Gangnam Severance Hospital
Seoul
About this study
Official title: Double Blinded, Randomized, Placebo Controlled, Multi-center, Phase II Exploratory Clinical Study to Evaluate the Efficacy, Dose-response and Safety of SA09012 in Bronchial Asthma Patients
Clinical Study to Evaluate the Efficacy, Dose-response and Safety of SA09012 in Bronchial Asthma Patients
- Conditions
- Mild to Moderate Bronchial Asthma
- Being tested
- SA09012 Low dose, SA09012 High dose, Placebo
- Keywords
- Asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SA09012 Low doseDrug
Tablet, b.i.d
SA09012 High doseDrug
Tablet, b.i.d
PlaceboDrug
Tablet, b.i.d
| Study group | Role | What they receive |
|---|---|---|
| SA09012 Low dose | Experimental | Not described Receives: Drug: SA09012 Low dose |
| SA09012 High dose | Experimental | Not described Receives: Drug: SA09012 High dose |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from baseline of PEF(Peak Expiratory Flow)at week 6
Measured: 6 week treatment period
Secondary outcomes (3)
Mean change from baseline in FEV1 at week 6
Measured: 6 week treatment period
Mean change from baseline in ACT(Asthma Control Test) at week 6
Measured: 6 week treatment period
Safety assessment(Comparison of the adverse event profiles throughout the course of the study)
Measured: 6 week treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2012 (estimated)
- Study startNov 2012
- Primary completionJul 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild to Moderate Bronchial AsthmaStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- SamA Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Young Kyoon Kim, MD, Principal investigator, Seoul St. Mary's Hospital, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01740986
- Sponsor's protocol ID
- SA09012-P2
- Status last verified
- Jan 2015
- First submitted
- 30 Nov 2012
- Last updated
- 16 Nov 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blinded, Randomized, Placebo Controlled, Multi-center, Phase II Exploratory Clinical Study to Evaluate the Efficacy, Dose-response and Safety of SA09012 in Bronchial Asthma Patients
- ClinicalTrials.gov ID
- NCT01740986
- Acronym / sponsor ID
- SA09012-P2
- Conditions
- Mild to Moderate Bronchial Asthma
- Keywords
- Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- SamA Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Jul 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 4 Dec 2012 (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.
Clinical Study to Evaluate the Efficacy, Dose-response and Safety of SA09012 in Bronchial Asthma Patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SA09012 Low dose | Experimental | Drug: SA09012 Low dose |
| SA09012 High dose | Experimental | Drug: SA09012 High dose |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis or presence of asthma within 3 months of the prestudy visit
- FEV1 or PEF between 60% and 85% of the predicted value at screening or within the 3 months of the prestudy visit
- Having signed an informed consent
Key exclusion criteria (4 listed)
- Patient who has severe asthma
- Patient who has any significant medical condition that might compromise patient safety, interfere with evaluation or preclude completion of the study other protocol-defined inclusion/exclusion criteria may apply
- Patient with an AST or ALT > 2x ULN (upper limit of normal) in the screening visit
- Patient with more than 10 pack year of cigarettes history
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 |
|---|---|---|
| SA09012 Low doseTablet, b.i.d | Drug | SA09012 Low dose |
| SA09012 High doseTablet, b.i.d | Drug | SA09012 High dose |
| PlaceboTablet, b.i.d | Drug | Placebo |
Primary outcome
Mean change from baseline of PEF(Peak Expiratory Flow)at week 6
Time frame: 6 week treatment period
3 secondary outcomes
Mean change from baseline in FEV1 at week 6
Time frame: 6 week treatment period
Mean change from baseline in ACT(Asthma Control Test) at week 6
Time frame: 6 week treatment period
Safety assessment(Comparison of the adverse event profiles throughout the course of the study)
Time frame: 6 week treatment period
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 Nov 2015.
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.
Young Kyoon Kim, MD principal investigator
Seoul St. Mary's Hospital, The Catholic University of Korea
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SA09012 Low dose and SA09012 High dose in people with Mild to Moderate Bronchial Asthma, run by SamA Pharmaceutical Co., Ltd at 14 sites 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 5 inclusion and 4 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 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites 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. 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?
Mean change from baseline of PEF(Peak Expiratory Flow)at week 6 (time frame: 6 week treatment period). 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 Nov 2015; AzTrials last refreshed its copy on 7 Nov 2026.