AsthmaPhase 1NCT01521455
Therapeutic Equivalence Study of HCP0910 250/50 Mcg to Seretide 250 Diskus in Asthmatic Patients
A Phase 1 study testing HCP0910 and Seretide Diskus in people with Asthma, run by Hanmi Pharmaceutical Company Limited at 7 sites in South Korea.
Trial summary
The purpose of this study is to prove that HCP0910 is therapeutically equivalent to Seretide 250 Diskus when repeatedly dosed to Asthmatic patients. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Asthma
- What is being tested?
- HCP0910 and Seretide Diskus
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 7 sitesSouth Korea
- Study dates
- Feb 2012to Jul 2013
- Phase
- Phase 1
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 20 ~ 75 inclusive
- Asthmatic diagnosis in more than 12 weeks from screening day
- Shows more than 12 % increase, and 200mL increase in FEV1 measure on Visit 2
Who cannot join
- Maintain controlled asthma for more than 4 weeks before screening
- Diagnosed as a severe asthmatic patients
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
South Korea7 sites
Soon Chun Hyang University Hospital Bucheon
Bucheon-si, Gyunggi -do
Asan Medical Center
Seoul
Ewha Womans University Medical Center
Seoul
Hanyang University Hospital
Seoul
Samsung medical center
Seoul
Seoul National University
Seoul
Ajou University Hospital
Suwon, Gyunggi -do
About this study
Official title: A Phase I, Randomized, Open, Multi-center, Cross Over Study to Evaluate the Therapeutic Equivalence of Repeated Dose of HCP0910 250/50 μg to SeretideTM 250 DiskusTM in Asthmatic Patients
The purpose of this study is to prove that HCP0910 is therapeutically equivalent to Seretide 250 Diskus when repeatedly dosed to Asthmatic patients.
- Conditions
- Asthma
- Being tested
- HCP0910, Seretide Diskus
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HCP0910Drug
250/50, BID for 2 weeks
Seretide DiskusDrug
250/50, BID for 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| HCP0910 | Experimental | Fluticasone /salmeterol 250/50 combination capsule Receives: Drug: HCP0910 |
| Seretide Diskus | Active comparator | Seretide 250 Diskus Receives: Drug: Seretide Diskus |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean change of morning predose FEV1 from baseline
Measured: day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2012 (estimated)
- Study startFeb 2012
- Primary completionJun 2013
- Study completionJul 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.
- More trials run by Hanmi Pharmaceutical Company LimitedThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanmi Pharmaceutical Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kyung-mi Park, Ph.D, Study director, Hanmi Pharmaceutical Co.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01521455
- Sponsor's protocol ID
- HM-FTOL-101
- Status last verified
- Aug 2013
- First submitted
- 26 Jan 2012
- Last updated
- 23 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Open, Multi-center, Cross Over Study to Evaluate the Therapeutic Equivalence of Repeated Dose of HCP0910 250/50 μg to SeretideTM 250 DiskusTM in Asthmatic Patients
- ClinicalTrials.gov ID
- NCT01521455
- Acronym / sponsor ID
- HM-FTOL-101
- Conditions
- Asthma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 30 Jan 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.
The purpose of this study is to prove that HCP0910 is therapeutically equivalent to Seretide 250 Diskus when repeatedly dosed to Asthmatic patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HCP0910 | Experimental | Drug: HCP0910Fluticasone /salmeterol 250/50 combination capsule |
| Seretide Diskus | Active comparator | Drug: Seretide DiskusSeretide 250 Diskus |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age 20 ~ 75 inclusive
- Asthmatic diagnosis in more than 12 weeks from screening day
- Shows more than 12 % increase, and 200mL increase in FEV1 measure on Visit 2
Key exclusion criteria (2 listed)
- Maintain controlled asthma for more than 4 weeks before screening
- Diagnosed as a severe asthmatic patients
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 |
|---|---|---|
| HCP0910250/50, BID for 2 weeks | Drug | HCP0910 |
| Seretide Diskus250/50, BID for 2 weeks | Drug | Seretide Diskus |
Primary outcome
mean change of morning predose FEV1 from baseline
Time frame: day 14
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 23 Aug 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.
Kyung-mi Park, Ph.D study director
Hanmi Pharmaceutical Co.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HCP0910 and Seretide Diskus in people with Asthma, run by Hanmi Pharmaceutical Company Limited at 7 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 3 inclusion and 2 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 23 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 of morning predose FEV1 from baseline (time frame: day 14). 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 23 Aug 2013.