AsthmaPhase 2NCT00936624
Dose Finding Trial to Assess the Efficacy and Safety of SOTB07 in Persistent Asthma
A Phase 2 study testing SOTB07 and montelukast in people with Asthma, run by SK Chemicals Co., Ltd. at 1 site in South Korea.
Trial summary
This study is a dose finding trial to assess the efficacy and safety of SOTB07 in persistent asthma. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- SOTB07 and montelukast
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 245 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2009to May 2011
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male or eligible female subjects aged 15 years or more
- A female is eligible if she is of:
- Non-child bearing potential (i.e., physiologically incapable of becoming pregnant), including any female who is at least 2 year after post- menopausal
- Child bearing potential and agrees to the acceptable contraceptive methods used consistently and correctly
- Negative pregnancy test at screening
- Non-smoker for at least 1 year, a pack history of ≤ 10 pack years
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- Symptom of persistent asthma, as defined by the National Institute of Health (NIH)
- 50% ≤ FEV1 ≤ 85% predicted at screening visit (withholding inhaled, short acting ß-agonist for 6 hours)
- FEV1 reversibility ≥ 12% and 200 ml at 20-30 minutes after inhalation of a short acting ß-agonist (Salbutamol 2 puffs; 200㎍) at Visit 1 or within 6 months before Visit 1
- Capable of withholding salbutamol use for ≥ 6 hours prior to clinic visits
- Appropriately signed and dated informed consent has been obtained
Who cannot join
- Active upper or lower respiratory tract infection within 3 weeks before visit 1
- Emergency room treatment for asthma within 1 month or hospitalization for asthma within 3 months before visit 1
- Any evidence of infectious, oncologic, or other active pulmonary disease obtained by chest radiography within 12 months before visit 1
- Clinically significant, in the opinion of the investigator, hematological, liver, renal, heart, neurological disease, or other serious disease
- Hypersensitivity to any β2-agonist, sympathomimetic drug, leukotriene receptor antagonist or Sophora tonkinensis Radix Rhizoma
- Clinically significant and uncontrolled psychiatric disease or history of drug or alcohol abuse
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- Inhaled, oral or parenteral corticosteroids within 4 weeks before visit 1
- Change of Immunotherapy within 6 months before visit 1
- Administration of the antiasthma agent within 1 week of visit 1
- Administration of any other medication which may affect the course of asthma, or interact with sympathomimetic amines
- Participation in study using an experimental medication within 1 month before visit 1
- Other ineligible subject in the opinion of the investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 12 Week, Multi-center,Randomized, Double Blinded, Parallel Group, Placebo-controlled, 4-arm, Dose Finding Trial to Assess the Efficacy and Safety of SOTB07 in Persistent Asthma
This study is a dose finding trial to assess the efficacy and safety of SOTB07 in persistent asthma.
Read the detailed description
A 12 week, Multi-center, Randomized, Double blinded, Parallel group, Placebo-controlled, 4-arm, Dose finding trial to Assess the Efficacy and Safety of SOTB07 in persistent asthma.
- Conditions
- Asthma
- Being tested
- SOTB07, placebo, montelukast
- Keywords
- Persistent asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SOTB07Drug
SOTB07 100mg
SOTB07Drug
SOTB07 200mg
placeboDrug
placebo
montelukastDrug
montelukast 10mg po, bid, 12week
| Study group | Role | What they receive |
|---|---|---|
| SOTB07 100mg | Experimental | Not described Receives: Drug: SOTB07 |
| SOTB07 200mg | Experimental | Not described Receives: Drug: SOTB07 |
| Placebo | Placebo comparator | Not described Receives: Drug: placebo |
| Montelukast 10mg | Active comparator | Not described Receives: Drug: montelukast |
What is being measured
The primary outcome is the main question the study is designed to answer.
% change from baseline for FEV1 at each visit
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionMay 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 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 245 participants (actual)
Sponsor and investigators
- Lead sponsor
- SK Chemicals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sangheon Cho, professor, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00936624
- Sponsor's protocol ID
- SOTB07_AST_II_2008
- Status last verified
- Dec 2013
- First submitted
- 8 Jul 2009
- Last updated
- 19 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12 Week, Multi-center,Randomized, Double Blinded, Parallel Group, Placebo-controlled, 4-arm, Dose Finding Trial to Assess the Efficacy and Safety of SOTB07 in Persistent Asthma
- ClinicalTrials.gov ID
- NCT00936624
- Acronym / sponsor ID
- SOTB07_AST_II_2008
- Conditions
- Asthma
- Keywords
- Persistent asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 245 participants (actual)
- Lead sponsor
- SK Chemicals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 10 Jul 2009 (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 study is a dose finding trial to assess the efficacy and safety of SOTB07 in persistent asthma.
Detailed description
A 12 week, Multi-center, Randomized, Double blinded, Parallel group, Placebo-controlled, 4-arm, Dose finding trial to Assess the Efficacy and Safety of SOTB07 in persistent asthma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SOTB07 100mg | Experimental | Drug: SOTB07 |
| SOTB07 200mg | Experimental | Drug: SOTB07 |
| Placebo | Placebo comparator | Drug: placebo |
| Montelukast 10mg | Active comparator | Drug: montelukast |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Male or eligible female subjects aged 15 years or more
- A female is eligible if she is of:
- Non-smoker for at least 1 year, a pack history of ≤ 10 pack years
- Symptom of persistent asthma, as defined by the National Institute of Health (NIH)
- 50% ≤ FEV1 ≤ 85% predicted at screening visit (withholding inhaled, short acting ß-agonist for 6 hours)
Key exclusion criteria (12 listed)
- Active upper or lower respiratory tract infection within 3 weeks before visit 1
- Emergency room treatment for asthma within 1 month or hospitalization for asthma within 3 months before visit 1
- Any evidence of infectious, oncologic, or other active pulmonary disease obtained by chest radiography within 12 months before visit 1
- Clinically significant, in the opinion of the investigator, hematological, liver, renal, heart, neurological disease, or other serious disease
- Hypersensitivity to any β2-agonist, sympathomimetic drug, leukotriene receptor antagonist or Sophora tonkinensis Radix Rhizoma
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 |
|---|---|---|
| SOTB07SOTB07 100mg | Drug | SOTB07 100mg |
| SOTB07SOTB07 200mg | Drug | SOTB07 200mg |
| placeboplacebo | Drug | Placebo |
| montelukastmontelukast 10mg po, bid, 12week | Drug | Montelukast 10mg |
Primary outcome
% change from baseline for FEV1 at each visit
Time frame: 12 weeks
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 19 Dec 2013.
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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.
Sangheon Cho, professor principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SOTB07 and montelukast in people with Asthma, run by SK Chemicals 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 11 inclusion and 12 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 19 Dec 2013. 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. 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?
% change from baseline for FEV1 at each visit (time frame: 12 weeks). 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 19 Dec 2013.