AsthmaPhase 2NCT01820481
Safety and Efficacy of WIN-901X in Asthma
A Phase 2 study testing WIN-901X dose level 1, WIN-901X dose level 2 and WIN-901X dose level 3 in people with Asthma, run by Whanin Pharmaceutical Company at 1 site in South Korea.
Trial summary
This clinical trial is designed to evaluate the efficacy, dose-response and safety of WIN-901X in Asthma patients. Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- Asthma
- What is being tested?
- WIN-901X dose level 1, WIN-901X dose level 2 and WIN-901X dose level 3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 209 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2012to Nov 2013
- 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
- Greater than or equal to 20 and less than 80 years of age
- Have physician diagnosed asthma with irreversible airway obstruction at least 6 months prior to the screening
- FEV1 between 60% and 85% before inhaling fast-acting bronchodilator at screening
- No history of smoking at least one year prior to the screening
- Having voluntarily signed an informed consent
Who cannot join
- Have visited emergency room due to the worsening asthma symptoms, within 4 weeks before the screening
- Have been hospitalized due to an acute worsening of asthma within 3 months before the screening
- Have a history of laryngitis, pyrexia, sinusitis, otitis media, respiratory tract infection, and infectious rhinitis within 4 weeks prior to the screening
- Have malignant tumor
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double Blinded, Randomized, Placebo Controlled, Multi-center, Phase 2 : Exploratory Clinical Study to Evaluate the Efficacy, Dose-response and Safety of WIN-901X in Asthma Patients
This clinical trial is designed to evaluate the efficacy, dose-response and safety of WIN-901X in Asthma patients.
Read the detailed description
Double blinded, Randomized, Placebo Controlled, Multi-center, Phase 2 : Exploratory Clinical Study to Evaluate the Efficacy, Dose-response and Safety of WIN-901X in Asthma Patients
- Conditions
- Asthma
- Being tested
- WIN-901X dose level 1, WIN-901X dose level 2, WIN-901X dose level 3, Placebo
- Keywords
- Asthma, Bronchial Diseases, Respiratory Tract Diseases, Lung Diseases, Obstructive, Lung Diseases
- Medical subject headings
- Asthma, Bronchial Diseases, Respiratory Tract Diseases, Lung Diseases, Obstructive, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WIN-901X dose level 1Drug
100mg Bid, PO, 12weeks
WIN-901X dose level 2Drug
200mg Bid, PO, 12weeks
WIN-901X dose level 3Drug
300mg Bid, PO, 12weeks
PlaceboDrug
Bid, PO, 12weeks
| Study group | Role | What they receive |
|---|---|---|
| Treatment 1 | Experimental | Not described Receives: Drug: WIN-901X dose level 1 |
| Treatment 2 | Experimental | Not described Receives: Drug: WIN-901X dose level 2 |
| Treatment 3 | Experimental | Not described Receives: Drug: WIN-901X dose level 3 |
| 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.
Compare the change of FEV1% to the baseline after the medication
FEV1: Forced Expiratory Volume In One Second
Measured: Baseline, week 12
Secondary outcomes (3)
Compare the change of ACQ to the baseline after the medication
ACQ: Asthma Control Questionnaire
Measured: Baseline, week 12
Ratio of the date, where no rescue drug was used, during the trial
Measured: Baseline, week 12
Ratio of symptom free days during the trial
Measured: Baseline, week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2013 (estimated)
- Study startSep 2012
- Primary completionNov 2013
- Study completionNov 2013
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 209 participants (actual)
Sponsor and investigators
- Lead sponsor
- Whanin Pharmaceutical Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Park Hae Sim, M.D., Professor, Study chair, Yes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01820481
- Sponsor's protocol ID
- WIN-901X-P2
- Status last verified
- Dec 2013
- First submitted
- 25 Mar 2013
- Last updated
- 9 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blinded, Randomized, Placebo Controlled, Multi-center, Phase 2 : Exploratory Clinical Study to Evaluate the Efficacy, Dose-response and Safety of WIN-901X in Asthma Patients
- ClinicalTrials.gov ID
- NCT01820481
- Acronym / sponsor ID
- WIN-901X-P2
- Conditions
- Asthma
- Keywords
- Asthma, Bronchial Diseases, Respiratory Tract Diseases, Lung Diseases, Obstructive, Lung Diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 209 participants (actual)
- Lead sponsor
- Whanin Pharmaceutical CompanyIndustry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 28 Mar 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.
This clinical trial is designed to evaluate the efficacy, dose-response and safety of WIN-901X in Asthma patients.
Detailed description
Double blinded, Randomized, Placebo Controlled, Multi-center, Phase 2 : Exploratory Clinical Study to Evaluate the Efficacy, Dose-response and Safety of WIN-901X in Asthma Patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment 1 | Experimental | Drug: WIN-901X dose level 1 |
| Treatment 2 | Experimental | Drug: WIN-901X dose level 2 |
| Treatment 3 | Experimental | Drug: WIN-901X dose level 3 |
| 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)
- Greater than or equal to 20 and less than 80 years of age
- Have physician diagnosed asthma with irreversible airway obstruction at least 6 months prior to the screening
- FEV1 between 60% and 85% before inhaling fast-acting bronchodilator at screening
- No history of smoking at least one year prior to the screening
- Having voluntarily signed an informed consent
Key exclusion criteria (4 listed)
- Have visited emergency room due to the worsening asthma symptoms, within 4 weeks before the screening
- Have been hospitalized due to an acute worsening of asthma within 3 months before the screening
- Have a history of laryngitis, pyrexia, sinusitis, otitis media, respiratory tract infection, and infectious rhinitis within 4 weeks prior to the screening
- Have malignant tumor
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 |
|---|---|---|
| WIN-901X dose level 1100mg Bid, PO, 12weeks | Drug | Treatment 1 |
| WIN-901X dose level 2200mg Bid, PO, 12weeks | Drug | Treatment 2 |
| WIN-901X dose level 3300mg Bid, PO, 12weeks | Drug | Treatment 3 |
| PlaceboBid, PO, 12weeks | Drug | Placebo |
Primary outcome
Compare the change of FEV1% to the baseline after the medication
Time frame: Baseline, week 12
FEV1: Forced Expiratory Volume In One Second
3 secondary outcomes
Compare the change of ACQ to the baseline after the medication
Time frame: Baseline, week 12
Ratio of the date, where no rescue drug was used, during the trial
Time frame: Baseline, week 12
Ratio of symptom free days during the trial
Time frame: Baseline, week 12
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 9 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.
Park Hae Sim, M.D., Professor study chair
Yes
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 WIN-901X dose level 1, WIN-901X dose level 2 and WIN-901X dose level 3 in people with Asthma, run by Whanin Pharmaceutical Company 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 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 9 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?
Compare the change of FEV1% to the baseline after the medication (time frame: Baseline, week 12). 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 9 Dec 2013.