- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02941679
Clinical Efficacy and Safety Evaluation of HCP1202 in COPD Patients
October 19, 2016 updated by: Hanmi Pharmaceutical Company Limited
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
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
252
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
- 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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: HCP1202
Test
|
Hanmi Pharmaceutical.
Co., Ltd.
Other Names:
|
Active Comparator: HGP1011
Control
|
Boehringer Ingelheim
Other Names:
|
Active Comparator: HCP0910
Control
|
GlaxoSmithKline
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from Baseline in Trough FEV1 at Week 12
Time Frame: Baseline, Week 12
|
Baseline, Week 12
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from Baseline in Trough FEV1 at Week 4 & 8
Time Frame: Baseline, Week 4, Week 8
|
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
|
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
|
Baseline, Week 4, Week 8, Week 12
|
Transition Dyspnea Index scores at Week 4 & 8 & 12
Time Frame: Week 4, Week 8, Week 12
|
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
|
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
|
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
|
Baseline through Week 12
|
Total Amount of Rescue Medication Used per Subject from Baseline to Week 12
Time Frame: Baseline through Week 12
|
Baseline through Week 12
|
Average Daily Use of Rescue Medication per Subject from Baseline to Week 12
Time Frame: Baseline through Week 12
|
Baseline through Week 12
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: HyoungKyu Yoon, M.D., Ph.D., Yeouido St. Mary's Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2016
Primary Completion (Anticipated)
February 1, 2018
Study Completion (Anticipated)
April 1, 2018
Study Registration Dates
First Submitted
October 14, 2016
First Submitted That Met QC Criteria
October 19, 2016
First Posted (Estimate)
October 21, 2016
Study Record Updates
Last Update Posted (Estimate)
October 21, 2016
Last Update Submitted That Met QC Criteria
October 19, 2016
Last Verified
October 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HM-FLUT-301
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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