Clinical Efficacy and Safety Evaluation of HCP1202 in COPD Patients

NCT ID: NCT02941679

Last Updated: 2016-10-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 252 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2018-04-30

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.

Conditions

Chronic Obstructive Pulmonary Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

HCP1202

Test

Group Type: EXPERIMENTAL

HCP1202

Intervention Type: DRUG

Hanmi Pharmaceutical. Co., Ltd.

HGP1011

Control

Group Type: ACTIVE_COMPARATOR

HGP1011

Intervention Type: DRUG

Boehringer Ingelheim

HCP0910

Control

Group Type: ACTIVE_COMPARATOR

HCP0910

Intervention Type: DRUG

GlaxoSmithKline

Interventions

HCP1202

Hanmi Pharmaceutical. Co., Ltd.

Intervention Type: DRUG

HGP1011

Boehringer Ingelheim

Intervention Type: DRUG

HCP0910

GlaxoSmithKline

Intervention Type: DRUG

Other Intervention Names

HCP1202 Capsule; HGP1011 Capsule; HCP0910 Capsule

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).

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hanmi Pharmaceutical Company Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

HyoungKyu Yoon, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Yeouido St. Mary's Hospital

Central Contacts

HyoungKyu Yoon, M.D., Ph.D.

Role: CONTACT

cmcyhg@catholic.ac.kr

Other Identifiers

HM-FLUT-301

Identifier Type: -

Identifier Source: org_study_id