A Phase 2a Study to Assess Safety, Daily Symptoms, Pharmacokinetics (PK), and Biomarkers of YPL-001 in Chronic Obstructive Pulmonary Disease (COPD) Patients

Overview

This is a Phase 2a, proof-of-concept, multicenter, randomized, double-blind, double dummy, 3-treatment, parallel study, with low and high YPL 001 doses (low dose and high dose twice daily [BID]) and a placebo control in moderate to severe Chronic Obstructive Pulmonary Disease (COPD) patients.

Full Title of Study: “A Randomized, Double-Blind, Placebo Controlled, Multicenter Phase 2a Study to Assess Safety, Daily Respiratory Symptoms, Pharmacokinetics, and Biomarker Variations After Administration of Either YPL-001, or Placebo in Patients With Moderate-to-Severe Chronic Obstructive Pulmonary Disease”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: October 31, 2017

Interventions

  • Drug: YPL-001 low dose
    • twice daily [BID]
  • Drug: YPL-001 high dose
    • twice daily [BID]
  • Drug: placebo
    • twice daily [BID]

Arms, Groups and Cohorts

  • Experimental: YPL-001 low dose
    • Active arm including patients who receive the YPL-001 low dose
  • Experimental: YPL-001 high dose
    • Active arm including patients who receive the YPL-001 high dose
  • Placebo Comparator: placebo
    • Control arm including patients who receive the placebo drug

Clinical Trial Outcome Measures

Primary Measures

  • Safety and tolerability of multiple doses of YPL-001 as assessed by number of adverse events (AEs)
    • Time Frame: Up to Day 70
    • An AEs means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. The number of AEs will be collected until the follow-up contact.
  • Safety and tolerability of multiple doses of YPL-001 as assessed by clinical laboratory tests
    • Time Frame: Up to Day 56
    • Clinical laboratory assessments will perform hematology, serum chemistry, serology, serum pregnancy test, urinalysis, and urine drug and alcohol screen. Hematology, chemistry, and urinalysis will be collected at baseline and on days 29 and 55.
  • Safety and tolerability of multiple doses of YPL-001 as assessed by vital signs
    • Time Frame: Up to Day 56
    • Measurements of vital signs (body temperature, respiratory rate, blood pressure, and heart rate) will be measured as schedule. When performed prior to the morning dose, blood pressure and heart rate will be measured within 2 hours prior to dosing. When scheduled, post dose vital signs readings will be performed within approximately 10 minutes of the scheduled time point. When performing the bronchoscopy, vital signs (body temperature, respiratory rate, blood pressure, and heart rate) will be monitored continuously until the end of the procedure.
  • Safety and tolerability of multiple doses of YPL-001 as assessed by 12-lead electrocardiogram (ECG)
    • Time Frame: Up to Day 56
    • Standard 12-lead ECG will be performed at the time points. Patients will be required to lie quietly in a supine position for at least 1 minute prior to ECG measurements. ECG parameters will be included pulse rate (PR), QT, and QT duration corrected for heart rate by Bazett’s formula (QTcB intervals).
  • Safety and tolerability of multiple doses of YPL-001 as assessed by physical examination
    • Time Frame: Up to Day 56
    • All full physical examinations will include, at a minimum, assessment of the following systems: skin, head, ears, eyes, nose and throat, respiratory system, cardiovascular system, gastrointestinal system, neurological condition, blood and lymphatic systems, and the musculoskeletal system.
  • Safety and tolerability of multiple doses of YPL-001 as assessed by pulse oximetry
    • Time Frame: Up to Day 56
    • Oxygen levels, saturation [%], and heart rate will be assessed using a pulse oximeter and measured with 2 hours of bronchoscopy procedures.

Secondary Measures

  • Change From Baseline in Peak Expiratory Flow (PEF)
    • Time Frame: Up to Day 56
    • The PEF assessments will be made daily prior to each dose from Day 1 of the Run-in Period to Day 56 of the Treatment Period. Three measurements will be made at each time point using a hand held PEF meter. Readings not performed in the clinical research unit (CRU) will be recorded in the patient e-diary. All PEF assessments should be performed before administration of a bronchodilator where possible.
  • Change From Baseline in Symptoms of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation
    • Time Frame: Up to Day 56
    • Patient will be asked to record the major (sputum quality, color, consistency) and minor (cough, wheeze, sore throat, nasal congestion, discharge, and body temperature above 100°F) symptoms of COPD exacerbation via the e-diary before each dosing.
  • Change From Baseline in Dyspnea (Modified Borg Dyspnea Scale)
    • Time Frame: Up to Day 56
    • Severity level of patient’s dyspnea will be accessed via the modified Borg dyspnea scale programmed within the e-diary. The modified Borg dyspnea scale is a self-administered categorical scale with a score from 0 to 10, where 0 (as a measure of dyspnea) corresponds to the sensation of normal breathing (absence of dyspnea) and 10 corresponds to the patient’s maximum possible sensation of dyspnea.
  • Change From Baseline in Duke Activity Status Index (DASI)
    • Time Frame: Up to Day 56
    • Patient’s functional capacity and activity status will be accessed via the DASI programmed within the e-diary. DASI is a self-administered 12-item questionnaire that assesses daily activities such as personal care, ambulation, household tasks, sexual function and recreation with respective metabolic costs. Each item has a specific weight based on the metabolic cost. The final score ranges between 0 and 58.2 points.

Participating in This Clinical Trial

Inclusion Criteria

  • Adult males and/or females, 40 to 80 years of age (inclusive).
  • History of COPD for at least 12 months prior to screening.
  • Diagnosed with COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS) guidelines with symptoms compatible with COPD for at least 12 months prior to screening.
  • Classified as moderate to severe COPD based on the current severity classification GOLD Stage 2-3 disease in terms of post-bronchodilator spirometry at screening
  • etc.

Exclusion Criteria

  • History of life-threatening COPD including respiratory arrest, intensive care unit admission and/or requiring intubation.
  • History of more than 2 hospitalizations for COPD within 12 months prior to screening.
  • Presentation of an acute exacerbation of COPD that will be associated with increase sputum volume or change in sputum color within 4 weeks before Day 1 of the Run-in Period.
  • Evidence of pulmonary heart disease, or clinically significant pulmonary hypertension.
  • etc.

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Yungjin Pharm. Co., Ltd.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Gerard J Criner, MD, Principal Investigator, Temple University
    • Mark T Dransfield, MD, Principal Investigator, The Kirklin Clinic of UAB Hospital
  • Overall Contact(s)
    • Gerard J Criner, MD, 1-215-707-8113

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.