AsthmaPhase 3NCT01907763
Study Phase III Study to Assess the Efficacy and Safety of SOTB07 in Asthma Patients
A Phase 3 study testing SOTB07 200mg and SOTB07 400mg in people with Asthma, run by SK Chemicals Co., Ltd. at 1 site in South Korea.
Trial summary
The objective of this study is to assess the efficacy and safety of SOTB07 in asthma patients by observing changes FEV1 (% predicted) as the primary efficacy endpoint after oral administration of SOTB07 200mg, 400mg, placebo for 12 weeks. 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 200mg and SOTB07 400mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 194 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2013to Oct 2015
- 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 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
- Symptom of persistent asthma, as defined by the National Institute of Health (NIH) 5.50% ≤ FEV1 ≤ 80% predicted at screening visit (withholding inhaled, short acting ß-agonist for 6 hours)
- 6.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 7.Capable of withholding salbutamol use for ≥ 6 hours prior to clinic visits 8.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
Show all 13Show fewer
- history of drug or alcohol abuse
- 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.
South Korea1 site
Seoul National University Hospital
Seoul, Seoul, 110-744
About this study
Official title: A 12-week, Multi-center, Randomized, Double Blinded, Parallel Group, Placebo-controlled Study to Assess the Efficacy and Safety of SOTB07 in Asthma Patients
The objective of this study is to assess the efficacy and safety of SOTB07 in asthma patients by observing changes FEV1 (% predicted) as the primary efficacy endpoint after oral administration of SOTB07 200mg, 400mg, placebo for 12 weeks.
Read the detailed description
A 12-week, Multi-center, Randomized, Double blinded, Parallel group, Placebo-controlled study to Assess the Efficacy and Safety of SOTB07 in asthma patients
- Conditions
- Asthma
- Being tested
- SOTB07 200mg, SOTB07 400mg, SOTB 200mg placebo, SOTB 400mg placebo
- Keywords
- asthma, SOTB07
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SOTB07 200mgDrug
SOTB07 400mgDrug
SOTB 200mg placeboDrug
Placebo of SOTB07 200mg
SOTB 400mg placeboDrug
Placebo of SOTB07 400mg
| Study group | Role | What they receive |
|---|---|---|
| SOTB07 200mg | Experimental | One tablet of SOTB07 200mg and One tablet of SOTB 400mg Placebo are administered twice a day. Receives: Drug: SOTB07 200mg; Drug: SOTB 400mg placebo |
| SOTB07 400mg | Experimental | One tablet of SOTB07 400mg and One tablet of SOTB 200mg Placebo are administered twice a day. Receives: Drug: SOTB07 400mg; Drug: SOTB 200mg placebo |
| Placebo | Placebo comparator | One tablet of SOTB 200mg Placebo and One tablet of SOTB 400mg Placebo are administered twice a day. Receives: Drug: SOTB 200mg placebo; Drug: SOTB 400mg placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
FEV1 change from the baseline
Measured: 12 weeks
Secondary outcomes (17)
Change in spirometer parameters
Measured: 12 weeks
Change in FeNO
Measured: 12 weeks
Change in AM/PM PEFR
Measured: 12 weeks
Change in diurnal asthma symptom score
Measured: 12 weeks
Change in the number of days with experience of nocturnal asthma symptoms
Measured: 12 weeks
Change in amount of beta-2 agonist used (puff/day)
Measured: 12 weeks
Proportion of rescue free day
Measured: 12 weeks
Proportion of asthma control day
Measured: 12 weeks
Proportion of asthma exacerbation
Measured: 12 weeks
Proportion of treatment failure (severe asthma exacerbation)
Measured: 12 weeks
Changes in asthma control questionaire score
Measured: 12 weeks
Changes in quality of life questionaire for adult korea asthmatics scores
Measured: 12 weeks
Changes in patient's global self assessment score
Measured: 12 weeks
Change in visual analogue scale for cough score
Measured: 12 weeks
Change in biomarkers (eosinophil, neutrophil, ECP, eotaxin) in blood sample
Measured: 12 weeks
Change in biomarkers (eosinophil, neutrophil, ECP, eotaxin) in sputum sample
Measured: 12 weeks
Assessment of Safety
Adverse Event/ Vital Sign/ Laboratory Test
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 posted25 Jul 2013 (estimated)
- Study startJan 2013
- Primary completionOct 2015
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- SK Chemicals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sangheon Cho, professor, Study chair, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01907763
- Sponsor's protocol ID
- SOTB07_AST_III_2012
- Status last verified
- Jan 2016
- First submitted
- 17 Jul 2013
- Last updated
- 28 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2016. 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 Study to Assess the Efficacy and Safety of SOTB07 in Asthma Patients
- ClinicalTrials.gov ID
- NCT01907763
- Acronym / sponsor ID
- SOTB07_AST_III_2012
- Conditions
- Asthma
- Keywords
- asthma, SOTB07
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 194 participants (actual)
- Lead sponsor
- SK Chemicals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- Oct 2015 (actual)
- First posted
- 25 Jul 2013 (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 objective of this study is to assess the efficacy and safety of SOTB07 in asthma patients by observing changes FEV1 (% predicted) as the primary efficacy endpoint after oral administration of SOTB07 200mg, 400mg, placebo for 12 weeks.
Detailed description
A 12-week, Multi-center, Randomized, Double blinded, Parallel group, Placebo-controlled study to Assess the Efficacy and Safety of SOTB07 in asthma patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SOTB07 200mg | Experimental | Drug: SOTB07 200mg, Drug: SOTB 400mg placeboOne tablet of SOTB07 200mg and One tablet of SOTB 400mg Placebo are administered twice a day. |
| SOTB07 400mg | Experimental | Drug: SOTB07 400mg, Drug: SOTB 200mg placeboOne tablet of SOTB07 400mg and One tablet of SOTB 200mg Placebo are administered twice a day. |
| Placebo | Placebo comparator | Drug: SOTB 200mg placebo, Drug: SOTB 400mg placeboOne tablet of SOTB 200mg Placebo and One tablet of SOTB 400mg Placebo are administered twice a day. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 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) 5.50% ≤ FEV1 ≤ 80% predicted at screening visit (withholding inhaled, short acting ß-agonist for 6 hours)
- 6.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 7.Capable of withholding salbutamol use for ≥ 6 hours prior to clinic visits 8.Appropriately signed and dated informed consent has been obtained
Key exclusion criteria (13 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 |
|---|---|---|
| SOTB07 200mg | Drug | SOTB07 200mg |
| SOTB07 400mg | Drug | SOTB07 400mg |
| SOTB 200mg placeboPlacebo of SOTB07 200mg | Drug | Placebo, SOTB07 400mg |
| SOTB 400mg placeboPlacebo of SOTB07 400mg | Drug | Placebo, SOTB07 200mg |
Primary outcome
FEV1 change from the baseline
Time frame: 12 weeks
17 secondary outcomes
Change in spirometer parameters
Time frame: 12 weeks
Change in FeNO
Time frame: 12 weeks
Change in AM/PM PEFR
Time frame: 12 weeks
Change in diurnal asthma symptom score
Time frame: 12 weeks
Change in the number of days with experience of nocturnal asthma symptoms
Time frame: 12 weeks
Change in amount of beta-2 agonist used (puff/day)
Time frame: 12 weeks
Proportion of rescue free day
Time frame: 12 weeks
Proportion of asthma control day
Time frame: 12 weeks
Proportion of asthma exacerbation
Time frame: 12 weeks
Proportion of treatment failure (severe asthma exacerbation)
Time frame: 12 weeks
Changes in asthma control questionaire score
Time frame: 12 weeks
Changes in quality of life questionaire for adult korea asthmatics scores
Time frame: 12 weeks
Changes in patient's global self assessment score
Time frame: 12 weeks
Change in visual analogue scale for cough score
Time frame: 12 weeks
Change in biomarkers (eosinophil, neutrophil, ECP, eotaxin) in blood sample
Time frame: 12 weeks
Change in biomarkers (eosinophil, neutrophil, ECP, eotaxin) in sputum sample
Time frame: 12 weeks
Assessment of Safety
Time frame: 12 weeks
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2016.
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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 study chair
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 3 study testing SOTB07 200mg and SOTB07 400mg 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 8 inclusion and 13 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: stopped early, as of the sponsor's last update on 28 Jan 2016. 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 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 was stopped early. Results are not available in the source record.
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?
FEV1 change from the baseline (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 28 Jan 2016.