A Randomized, Double-Blind, Placebo Controlled, Multicenter 2a Study to Assess Safety, Daily Respiratory Symptoms, PK, and Biomarker Variations After Administration of Either YPL-001, or Placebo in Patients With Moderate-to-Severe COPD.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 4
- 主要终点
- Treatment-Emergent Adverse Event Frequency by Treatment - Adverse Events
研究概览
简要总结
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.
详细描述
Treatments are described as follows:
Treatment A: Multiple oral YPL-001 80 mg doses (1 x 80 mg tablet + 1 x 1 YPL-001 80 mg matching placebo tablet) will be administered approximately every 12 hours under fasting conditions for 55 consecutive days. Only the morning dose will be administered on Day 56.
Treatment B: Multiple oral YPL-001 160 mg doses (2 x 80 mg tablets) will be administered approximately every 12 hours under fasting conditions for 55 consecutive days. Only the morning dose will be administered on Day 56.
Treatment C: Multiple oral matching placebo (2 x 1 YPL-001 80 mg matching placebo tablets) will be administered approximately every 12 hours under fasting conditions for 55 consecutive days. Only the morning dose will be administered on Day 56. In all treatments, one tiotropium (Spiriva® HandiHaler®) 18 μg capsule will also be administered QD every morning prior to study drugs administration. Albuterol will be administered on an as needed basis. Each dose of Treatments A, B and C will be administered orally with approximately 240 mL of water.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult males and/or females, 30 to 85 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
排除标准
- •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.
研究组 & 干预措施
Treatment A
Multiple oral YPL-001 80 mg doses (1 x 80 mg tablet + 1 x 1 YPL-001 80 mg matching placebo tablet) are administered approximately every 12 hours under fasting conditions for 55 consecutive days.
干预措施: YPL-001 80 mg (Drug)
Treatment B
Multiple oral YPL-001 160 mg doses (2 x 80 mg tablets) are administered approximately every 12 hours under fasting conditions for 55 consecutive days.
干预措施: YPL-001 160 mg (Drug)
Treatment C
Multiple oral matching placebo (2 x 1 YPL-001 80 mg matching placebo tablets) will be administered approximately every 12 hours under fasting conditions for 55 consecutive days.
干预措施: Placebo (Drug)
结局指标
主要结局
Treatment-Emergent Adverse Event Frequency by Treatment - Adverse Events
时间窗: Up to Day 56
A TEAE was defined as an AE that was starting or worsening at the time of or after study drug administration. All AEs collected by the clinics and recorded in the CRF were captured in the database and were listed in by-patient data listings.
Treatment-Emergent Adverse Event Frequency by Treatment, Severity, and Relationship to Drug - Number of Patients Reporting Events
时间窗: Up to Day 56
When a patient experienced the same AE at more than one level of severity, the patient was counted once under the highest severity.
Treatment-Emergent Adverse Event Frequency by Treatment, Severity, and Relationship to Drug - Adverse Events
时间窗: Up to Day 56
When a patient experienced the same AE at more than one level of severity, the patient was counted once under the highest severity.
Treatment-Emergent Adverse Event Frequency by Treatment - Number of Patients Reporting Events
时间窗: Up to Day 56
A TEAE was defined as an AE that was starting or worsening at the time of or after study drug administration. All AEs collected by the clinics and recorded in the CRF were captured in the database and were listed in by-patient data listings.
次要结局
- Change From Baseline in Dyspnea (Modified Borg Dyspnea Scale)(Baseline to Day 55)
- Change From Baseline in Main Peak Expiratory Flow (PEF) Measured Daily(Baseline to Day 55)
- Change From Baseline of Symptom Severity Score for Symptoms of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation(Baseline to Day 55)
- Change From Baseline of Calculated Score From Duke Activity Status Index (DASI)(Baseline to Day 55)