Chronic Obstructive Pulmonary DiseasePhase 3NCT02941679
Clinical Efficacy and Safety Evaluation of HCP1202 in COPD Patients
A Phase 3 study testing HCP1202, HGP1011 and HCP0910 in people with Chronic Obstructive Pulmonary Disease, run by Hanmi Pharmaceutical Company Limited.
Trial summary
A phase 3 study to evaluate efficacy and safety of HCP1202 Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- HCP1202, HGP1011 and HCP0910
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 252 participants
- Where
- No sites listed yet
- Study dates
- Oct 2016to Apr 2018
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or Female adults aged ≥ 40 years.
- Patients diagnosed with COPD.
- Patients with FEV1/FVC < 0.7 at screening.
- Patients with a post-bronchodilator FEV1 < 60% of the predicted normal OR Patients with a post-bronchodilator FEV1 < 80% of the predicted normal if COPD exacerbation is moderate or worse developed at least twice within the past year or hospitalization occurred at least once within the past year due to COPD exacerbation.
- Patients with COPD Assessment Test ≥ 10.
- Patients with a history (current or ex-smokers) of smoking 10 pack-years or more (e.g. 10 pack years = 1 pack/day x 10 years, or ½ pack/day x 20 years).
- Patients who understand the process of clinical trial and signed written informed consent.
Who cannot join
- Patients with a current diagnosis of asthma.
- Patients with the following lung disorders that can affect the clinical trial, except for COPD: lung cancer, interstitial lung disease, thromboembolic pulmonary disease, moderate to severe bronchiectasis, sarcoidosis, pulmonary fibrosis, pulmonary hypertension, active tuberculosis, clinically significant tuberculous destroyed lung, alpha1-antitrypsin deficiency, etc.
- Patients underwent pulmonary lobectomy or lung volume reduction surgery within the past year.
- Patients who developed COPD exacerbation where antibiotics and/or systemic corticosteroids and/or hospitalization is advisable within 4 weeks prior to Visit 1 or during Run-in period (but, re-screening is possible 4 weeks after resolution of the COPD exacerbation occurred within 4 weeks prior to Visit 1).
- Patients who administered antibiotics for lower respiratory infection within 4 weeks prior to Visit 1 or during Run-in period (but, re-screening is possible 4 weeks after resolution of COPD exacerbation occurred within 4 weeks prior to Visit 1).
- Patients who have changed the COPD treatment method within 12 weeks prior to Visit 1 (but, PDE4 inhibitor can be used until 4 weeks prior to Visit 1).
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- Patients administered systemic corticosteroids within 4 weeks prior to Visit 1.
- Patients with the following clinically significant cardiovascular diseases: a history of myocardial infarction or unstable angina within 6 months prior to Visit 1, a history of unstable arrhythmia where its therapy method has been changed within 1 year prior to Visit 1, a history of hospitalization from NYHA Class III-IV heart failure, a history of atrial fibrillation, negative cardiac tachycardia, and/or hypertrophic cardiomyopathy.
- Patients with a history of long QTc syndrome.
- Patients with the clinical significance of ECG abnormality at screening (QTc(F) ≥ 470 ms).
- Patients who require long-term oxygen therapy for more than 12 hours a day.
- Patients participated in acute respiratory rehabilitation within 6 months prior to Visit 1 (except for the patients under stabilized respiratory rehabilitation therapy of at least 6 weeks).
Trial locations and contacts
No sites are listed yet.
HyoungKyu Yoon, M.D., Ph.D. contact
About this study
Official title: A 24-week, Randomized, Double-Blind, Active-controlled, Parallel Study of HCP1202 Combination Product, HGP1011, and HCP0910 in Treatment of Subjects With COPD
A phase 3 study to evaluate efficacy and safety of HCP1202
Read the detailed description
This study is designed as a multi-center, double-blinded, randomized, phase 3 clinical trial to evaluate the efficacy and safety of HCP1202 compared to either treatment with HGP1011 or HCP0910 in COPD patients.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- HCP1202, HGP1011, HCP0910
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HCP1202Drug
Also called HCP1202 Capsule
Hanmi Pharmaceutical. Co., Ltd.
HGP1011Drug
Also called HGP1011 Capsule
Boehringer Ingelheim
HCP0910Drug
Also called HCP0910 Capsule
GlaxoSmithKline
| Study group | Role | What they receive |
|---|---|---|
| HCP1202 | Experimental | Test Receives: Drug: HCP1202 |
| HGP1011 | Active comparator | Control Receives: Drug: HGP1011 |
| HCP0910 | Active comparator | Control Receives: Drug: HCP0910 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Trough FEV1 at Week 12
Measured: Baseline, Week 12
Secondary outcomes (9)
Change from Baseline in Trough FEV1 at Week 4 & 8
Measured: Baseline, Week 4, Week 8
Change from Baseline in Trough FVC at Week 4 & 8 & 12
Measured: Baseline, Week 4, Week 8, Week 12
Change from Baseline in Trough FEV1/FVC at Week 4 & 8 & 12
Measured: Baseline, Week 4, Week 8, Week 12
Transition Dyspnea Index scores at Week 4 & 8 & 12
Measured: Week 4, Week 8, Week 12
Change from Baseline in Total SGRQ-C (St. George's Respiratory Questionnaire for COPD patients) and sectional scores at Week 4 & 8 & 12
Measured: Baseline, Week 4, Week 8, Week 12
Percentage (%) of Subjects Experienced with Moderate to Severe COPD Exacerbation from Baseline to Week 12
Measured: Baseline through Week 12
Number of Occurrences in Moderate to Severe COPD Exacerbation per Subject from Baseline to Week 12
Measured: Baseline through Week 12
Total Amount of Rescue Medication Used per Subject from Baseline to Week 12
Measured: Baseline through Week 12
Average Daily Use of Rescue Medication per Subject from Baseline to Week 12
Measured: Baseline through Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionFeb 2018 (estimated)
- Study completionApr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 252 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hanmi Pharmaceutical Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- HyoungKyu Yoon, M.D., Ph.D., Principal investigator, Yeouido St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02941679
- Sponsor's protocol ID
- HM-FLUT-301
- Status last verified
- Oct 2016
- First submitted
- 14 Oct 2016
- Last updated
- 21 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 24-week, Randomized, Double-Blind, Active-controlled, Parallel Study of HCP1202 Combination Product, HGP1011, and HCP0910 in Treatment of Subjects With COPD
- ClinicalTrials.gov ID
- NCT02941679
- Acronym / sponsor ID
- HM-FLUT-301
- Conditions
- Chronic Obstructive Pulmonary Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 252 participants (estimated)
- Lead sponsor
- Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
- Study start
- Oct 2016
- Primary completion
- Feb 2018 (estimated)
- Study completion
- Apr 2018 (estimated)
- First posted
- 21 Oct 2016 (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.
A phase 3 study to evaluate efficacy and safety of HCP1202
Detailed description
This study is designed as a multi-center, double-blinded, randomized, phase 3 clinical trial to evaluate the efficacy and safety of HCP1202 compared to either treatment with HGP1011 or HCP0910 in COPD patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HCP1202 | Experimental | Drug: HCP1202Test |
| HGP1011 | Active comparator | Drug: HGP1011Control |
| HCP0910 | Active comparator | Drug: HCP0910Control |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or Female adults aged ≥ 40 years.
- Patients diagnosed with COPD.
- Patients with FEV1/FVC < 0.7 at screening.
- Patients with a post-bronchodilator FEV1 < 60% of the predicted normal OR Patients with a post-bronchodilator FEV1 < 80% of the predicted normal if COPD exacerbation is moderate or worse developed at least twice within the past year or hospitalization occurred at least once within the past year due to COPD exacerbation.
- Patients with COPD Assessment Test ≥ 10.
Key exclusion criteria (12 listed)
- Patients with a current diagnosis of asthma.
- Patients with the following lung disorders that can affect the clinical trial, except for COPD: lung cancer, interstitial lung disease, thromboembolic pulmonary disease, moderate to severe bronchiectasis, sarcoidosis, pulmonary fibrosis, pulmonary hypertension, active tuberculosis, clinically significant tuberculous destroyed lung, alpha1-antitrypsin deficiency, etc.
- Patients underwent pulmonary lobectomy or lung volume reduction surgery within the past year.
- Patients who developed COPD exacerbation where antibiotics and/or systemic corticosteroids and/or hospitalization is advisable within 4 weeks prior to Visit 1 or during Run-in period (but, re-screening is possible 4 weeks after resolution of the COPD exacerbation occurred within 4 weeks prior to Visit 1).
- Patients who administered antibiotics for lower respiratory infection within 4 weeks prior to Visit 1 or during Run-in period (but, re-screening is possible 4 weeks after resolution of COPD exacerbation occurred within 4 weeks prior to Visit 1).
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 |
|---|---|---|
| HCP1202Also: HCP1202 CapsuleHanmi Pharmaceutical. Co., Ltd. | Drug | HCP1202 |
| HGP1011Also: HGP1011 CapsuleBoehringer Ingelheim | Drug | HGP1011 |
| HCP0910Also: HCP0910 CapsuleGlaxoSmithKline | Drug | HCP0910 |
Primary outcome
Change from Baseline in Trough FEV1 at Week 12
Time frame: Baseline, Week 12
9 secondary outcomes
Change from Baseline in Trough FEV1 at Week 4 & 8
Time frame: Baseline, Week 4, Week 8
Change from Baseline in Trough FVC at Week 4 & 8 & 12
Time frame: Baseline, Week 4, Week 8, Week 12
Change from Baseline in Trough FEV1/FVC at Week 4 & 8 & 12
Time frame: Baseline, Week 4, Week 8, Week 12
Transition Dyspnea Index scores at Week 4 & 8 & 12
Time frame: Week 4, Week 8, Week 12
Change from Baseline in Total SGRQ-C (St. George's Respiratory Questionnaire for COPD patients) and sectional scores at Week 4 & 8 & 12
Time frame: Baseline, Week 4, Week 8, Week 12
Percentage (%) of Subjects Experienced with Moderate to Severe COPD Exacerbation from Baseline to Week 12
Time frame: Baseline through Week 12
Number of Occurrences in Moderate to Severe COPD Exacerbation per Subject from Baseline to Week 12
Time frame: Baseline through Week 12
Total Amount of Rescue Medication Used per Subject from Baseline to Week 12
Time frame: Baseline through Week 12
Average Daily Use of Rescue Medication per Subject from Baseline to Week 12
Time frame: Baseline through Week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2016.
- Individual participant dataSharing planned: No
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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.
HyoungKyu Yoon, M.D., Ph.D. contact
HyoungKyu Yoon, M.D., Ph.D. principal investigator
Yeouido St. Mary's Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HCP1202, HGP1011 and HCP0910 in people with Chronic Obstructive Pulmonary Disease, run by Hanmi Pharmaceutical Company Limited.
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 7 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: status not confirmed, as of the sponsor's last update on 21 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact HyoungKyu Yoon, M.D., Ph.D. (cmcyhg@catholic.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Trough FEV1 at Week 12 (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 21 Oct 2016.