Clinical Efficacy and Safety Evaluation of HCP1202 in COPD Patients

NCT02941679 | Unknown Phase 3

• 1 other identifier: HM-FLUT-301
• Study Type: interventional
• Target: 252
• Locations: 0 countries
• Sites: N/A

Brief Summary

A phase 3 study to evaluate efficacy and safety of HCP1202

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Trough FEV1 at Week 12

  Baseline, Week 12

Secondary Outcomes (9)

• Change from Baseline in Trough FEV1 at Week 4 & 8

  Baseline, Week 4, Week 8

• Change from Baseline in Trough FVC at Week 4 & 8 & 12

  Baseline, Week 4, Week 8, Week 12

• Change from Baseline in Trough FEV1/FVC at Week 4 & 8 & 12

  Baseline, Week 4, Week 8, Week 12

• Transition Dyspnea Index scores at Week 4 & 8 & 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

  Baseline, Week 4, Week 8, Week 12

Study Arms (3)

HCP1202

EXPERIMENTAL

Test

Drug: HCP1202

HGP1011

ACTIVE COMPARATOR

Control

Drug: HGP1011

HCP0910

ACTIVE COMPARATOR

Control

Drug: HCP0910

Interventions

HCP1202 DRUG

Hanmi Pharmaceutical. Co., Ltd.

Also known as: HCP1202 Capsule

HCP1202

HGP1011 DRUG

Boehringer Ingelheim

Also known as: HGP1011 Capsule

HGP1011

HCP0910 DRUG

GlaxoSmithKline

Also known as: HCP0910 Capsule

HCP0910

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Hanmi Pharmaceutical Company Limited: lead

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• HyoungKyu Yoon, M.D., Ph.D.

  Yeouido St. Mary's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

cmcyhg@catholic.ac.kr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2016
• First Posted: October 21, 2016
• Study Start: October 1, 2016
• Primary Completion: February 1, 2018
• Study Completion: April 1, 2018
• Last Updated: October 21, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share