Clinical Efficacy and Safety Evaluation of HCP1202 in COPD Patients
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
HCP1202
HGP1011
HCP0910
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease
Eligibility Criteria
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).
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
HCP1202
HGP1011
HCP0910
Arm Description
Test
Control
Control
Outcomes
Primary Outcome Measures
Change from Baseline in Trough FEV1 at Week 12
Secondary Outcome Measures
Change from Baseline in Trough FEV1 at Week 4 & 8
Change from Baseline in Trough FVC at Week 4 & 8 & 12
Change from Baseline in Trough FEV1/FVC at Week 4 & 8 & 12
Transition Dyspnea Index scores at Week 4 & 8 & 12
Change from Baseline in Total SGRQ-C (St. George's Respiratory Questionnaire for COPD patients) and sectional scores at Week 4 & 8 & 12
Percentage (%) of Subjects Experienced with Moderate to Severe COPD Exacerbation from Baseline to Week 12
Number of Occurrences in Moderate to Severe COPD Exacerbation per Subject from Baseline to Week 12
Total Amount of Rescue Medication Used per Subject from Baseline to Week 12
Average Daily Use of Rescue Medication per Subject from Baseline to Week 12
Full Information
NCT ID
NCT02941679
First Posted
October 14, 2016
Last Updated
October 19, 2016
Sponsor
Hanmi Pharmaceutical Company Limited
1. Study Identification
Unique Protocol Identification Number
NCT02941679
Brief Title
Clinical Efficacy and Safety Evaluation of HCP1202 in COPD Patients
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
October 2016 (undefined)
Primary Completion Date
February 2018 (Anticipated)
Study Completion Date
April 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hanmi Pharmaceutical Company Limited
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
252 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HCP1202
Arm Type
Experimental
Arm Description
Test
Arm Title
HGP1011
Arm Type
Active Comparator
Arm Description
Control
Arm Title
HCP0910
Arm Type
Active Comparator
Arm Description
Control
Intervention Type
Drug
Intervention Name(s)
HCP1202
Other Intervention Name(s)
HCP1202 Capsule
Intervention Description
Hanmi Pharmaceutical. Co., Ltd.
Intervention Type
Drug
Intervention Name(s)
HGP1011
Other Intervention Name(s)
HGP1011 Capsule
Intervention Description
Boehringer Ingelheim
Intervention Type
Drug
Intervention Name(s)
HCP0910
Other Intervention Name(s)
HCP0910 Capsule
Intervention Description
GlaxoSmithKline
Primary Outcome Measure Information:
Title
Change from Baseline in Trough FEV1 at Week 12
Time Frame
Baseline, Week 12
Secondary Outcome Measure Information:
Title
Change from Baseline in Trough FEV1 at Week 4 & 8
Time Frame
Baseline, Week 4, Week 8
Title
Change from Baseline in Trough FVC at Week 4 & 8 & 12
Time Frame
Baseline, Week 4, Week 8, Week 12
Title
Change from Baseline in Trough FEV1/FVC at Week 4 & 8 & 12
Time Frame
Baseline, Week 4, Week 8, Week 12
Title
Transition Dyspnea Index scores at Week 4 & 8 & 12
Time Frame
Week 4, Week 8, Week 12
Title
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
Title
Percentage (%) of Subjects Experienced with Moderate to Severe COPD Exacerbation from Baseline to Week 12
Time Frame
Baseline through Week 12
Title
Number of Occurrences in Moderate to Severe COPD Exacerbation per Subject from Baseline to Week 12
Time Frame
Baseline through Week 12
Title
Total Amount of Rescue Medication Used per Subject from Baseline to Week 12
Time Frame
Baseline through Week 12
Title
Average Daily Use of Rescue Medication per Subject from Baseline to Week 12
Time Frame
Baseline through Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
HyoungKyu Yoon, M.D., Ph.D.
Email
cmcyhg@catholic.ac.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
HyoungKyu Yoon, M.D., Ph.D.
Organizational Affiliation
Yeouido St. Mary's Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Clinical Efficacy and Safety Evaluation of HCP1202 in COPD Patients
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