AsthmaPhase 2NCT01424124
Safety and Efficacy of YHD001 in Asthma
A Phase 2 study testing YHD001 dose level 1, YHD001 dose level 2 and Singulair in people with Asthma, run by Yuhan Corporation at 1 site in South Korea.
Trial summary
The main objective is to evaluate the safety/tolerability and efficacy of YHD001 compared to singulair or placebo in patients (n=96) with partially controlled asthma. The study will conduct with 4 comparative groups orally treated with YHD001 dose level 1(t.i.d.), YHD001 dose level 2(t.i.d.), singulair 10mg(q.d.) or… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- YHD001 dose level 1, YHD001 dose level 2 and Singulair
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2011to Jan 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of signed written informed consent
- Acceptable medical history, physical exam,laboratory tests and EKG, during screening
- Nonsmoking (for longer than 1 year) patients with asthma
- Reversible airways obstruction (an increase in FEV1 absolute value of 12% or greater) 20 to 30 minutes after inhalation of b-agonist
- FEV1 between 50% and 85% of the predicted value (withholding short-acting, inhaled b2-adrenergic agonist for 6 hours)
Who cannot join
- History of any clinically significant disease
- History of drug/chemical/alcohol abuse
- Active upper respiratory tract infection within 3 weeks, emergency room treatment for asthma within 1 month, or hospitalization for asthma within 3 months of the prestudy visit
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Double-blind, Placebo/Active-controlled, Multi-center Clinical Trial to Investigate the Safety/Tolerability and Efficacy of YHD001 Following 8 Weeks Oral Administration of YHD001 in Patients With Partially Controlled Asthma
The main objective is to evaluate the safety/tolerability and efficacy of YHD001 compared to singulair or placebo in patients (n=96) with partially controlled asthma.
The study will conduct with 4 comparative groups orally treated with YHD001 dose level 1(t.i.d.), YHD001 dose level 2(t.i.d.), singulair 10mg(q.d.) or Placebo for 8 weeks.
Read the detailed description
Singulair: Montelukast sodium (leukotriene modulator)
- Conditions
- Asthma
- Being tested
- YHD001 dose level 1, YHD001 dose level 2, Singulair, Placebo
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YHD001 dose level 1Drug
Tablet, three times daily / 8 weeks
YHD001 dose level 2Drug
Tablet, three times daily / 8 weeks
SingulairDrug
Tablet, one times daily / 8 weeks
PlaceboDrug
Tablet, one times daily / 7 days
| Study group | Role | What they receive |
|---|---|---|
| YHD001 dose level 1 | Experimental | Not described Receives: Drug: YHD001 dose level 1 |
| YHD001 dose level 2 | Experimental | Not described Receives: Drug: YHD001 dose level 2 |
| Singulair | Active comparator | Not described Receives: Drug: Singulair |
| 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.
Change from baseline of FEV1 at week 4
FEV1: Forced Expiratory Volume In One Second
Measured: Baseline, week 4
Secondary outcomes (5)
Change from baseline of FEV1 at week 8
Measured: Baseline, week 8
Change from baseline of PEFR at week 8
PEFR: Peak Expiratory Flow Rate
Measured: Baseline, week 8
Change from baseline of ACT Score at week 8
ACT: Asthma control test
Measured: Baseline, week 8
Change from baseline of using rescue medication(b-Agonist) at week 8
Measured: Baseline, week 8
safety assessment
Comparison of the adverse event profiles throughout the course of the study
Measured: week 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2011 (estimated)
- Study startNov 2011
- Primary completionJun 2013
- Study completionJan 2014
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.
- More trials run by Yuhan CorporationThe sponsor's other registered studies.
- 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
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuhan Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01424124
- Sponsor's protocol ID
- YHD001-201
- Status last verified
- Jul 2014
- First submitted
- 24 Aug 2011
- Last updated
- 10 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Placebo/Active-controlled, Multi-center Clinical Trial to Investigate the Safety/Tolerability and Efficacy of YHD001 Following 8 Weeks Oral Administration of YHD001 in Patients With Partially Controlled Asthma
- ClinicalTrials.gov ID
- NCT01424124
- Acronym / sponsor ID
- YHD001-201
- Conditions
- Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Yuhan CorporationIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 26 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 main objective is to evaluate the safety/tolerability and efficacy of YHD001 compared to singulair or placebo in patients (n=96) with partially controlled asthma.
The study will conduct with 4 comparative groups orally treated with YHD001 dose level 1(t.i.d.), YHD001 dose level 2(t.i.d.), singulair 10mg(q.d.) or Placebo for 8 weeks.
Detailed description
Singulair: Montelukast sodium (leukotriene modulator)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| YHD001 dose level 1 | Experimental | Drug: YHD001 dose level 1 |
| YHD001 dose level 2 | Experimental | Drug: YHD001 dose level 2 |
| Singulair | Active comparator | Drug: Singulair |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Provision of signed written informed consent
- Acceptable medical history, physical exam,laboratory tests and EKG, during screening
- Nonsmoking (for longer than 1 year) patients with asthma
- Reversible airways obstruction (an increase in FEV1 absolute value of 12% or greater) 20 to 30 minutes after inhalation of b-agonist
- FEV1 between 50% and 85% of the predicted value (withholding short-acting, inhaled b2-adrenergic agonist for 6 hours)
Key exclusion criteria (3 listed)
- History of any clinically significant disease
- History of drug/chemical/alcohol abuse
- Active upper respiratory tract infection within 3 weeks, emergency room treatment for asthma within 1 month, or hospitalization for asthma within 3 months of the prestudy visit
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 |
|---|---|---|
| YHD001 dose level 1Tablet, three times daily / 8 weeks | Drug | YHD001 dose level 1 |
| YHD001 dose level 2Tablet, three times daily / 8 weeks | Drug | YHD001 dose level 2 |
| SingulairTablet, one times daily / 8 weeks | Drug | Singulair |
| PlaceboTablet, one times daily / 7 days | Drug | Placebo |
Primary outcome
Change from baseline of FEV1 at week 4
Time frame: Baseline, week 4
FEV1: Forced Expiratory Volume In One Second
5 secondary outcomes
Change from baseline of FEV1 at week 8
Time frame: Baseline, week 8
Change from baseline of PEFR at week 8
Time frame: Baseline, week 8
Change from baseline of ACT Score at week 8
Time frame: Baseline, week 8
Change from baseline of using rescue medication(b-Agonist) at week 8
Time frame: Baseline, week 8
safety assessment
Time frame: week 9
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 Jul 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 YHD001 dose level 1, YHD001 dose level 2 and Singulair in people with Asthma, run by Yuhan Corporation 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 5 inclusion and 3 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 Jul 2014. 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 of FEV1 at week 4 (time frame: Baseline, week 4). 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 Jul 2014.