EUCTR2021-001732-25-ES进行中（未招募）1 期
A phase IIa, randomized, double blind, placebo-controlled study to assess the effect of PBF-680 in patients with moderate to severe COPD on top of standard medication.
Palobiofarma, S.0 个研究点目标入组 102 人开始时间: 2021年7月2日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 102
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Sign an informed consent document indicating they understand the purpose of and procedures required for the study and are willing to participate in the study.
- •2.Male or female aged between 40 and 80 years inclusive, at the time of informed consent.
- •3.If male: unless surgically sterile, must agree to meet the following from the first dose up to the Follow-up, 2 weeks after the last dose of study medication:
- •Not donate sperm
- •Either: be sexually abstinent in accordance with a patient's usual and preferred lifestyle (but agree to abide by the contraception requirements below should their circumstances change)
- •Or: use a condom with all sexual partners. If the partner is a female of childbearing potential the condom must be used with spermicide and a second reliable form of contraception must also be used (e.g. diaphragm/cap with spermicide, established hormonal contraception, intra-uterine device)
- •If female: be of non-childbearing potential, or use a highly effective form of contraception as defined in Appendix I. Female patients of childbearing potential must use this contraceptive from first dose until the Follow-up (2 weeks after final dose) and have a negative pregnancy test at Visit 1 and Visit 2 prior to randomization.
- •4.Have a 12-lead ECG recording at screening (Visit 1) showing the following (and no changes at Visit 2 deemed clinically significant by the Investigator):
- •Heart rate between 50 and 90 beats per minute
- •QT interval corrected for heart rate using Fridericia's formula (QTcF) interval = 450 msec for males and = 470 msec for females.
- •QRS complex = 120 msec
- •PR interval = 200 msec
- •No clinically significant abnormality including morphology (e.g. left bundle branch block, atrioventricular nodal dysfunction, ST segment abnormality consistent with ischemia).
- •5.Capable of complying with all study restrictions and procedures.
- •6.Body mass index (BMI) between 20 and 35 kg/m2 (inclusive)
- •7.COPD diagnosis: Patients with a clinical diagnosis of COPD as defined by Global Initiative for Chronic Obstructive Lung Disease – GOLD 2020 with symptoms compatible with COPD for at least 1 year prior to screening (Visit 1).
- •8.Background triple therapy (ICS + LABA + LAMA) or double therapy (ICS + LABA or ICS + LAMA) for 3 months prior to randomization with a stable dose of medication for =1 month prior to Visit 1.
- •9.Patient with blood eosinophils >100 cells/µL
- •10.Ability to perform acceptable and reproducible spirometry. Post- bronchodilator (albuterol/salbutamol four puffs) spirometry at screening (Visit 1) must demonstrate a:
- •Post-bronchodilator FEV1/FVC ratio = 0.70
- •Post-bronchodilator FEV1 = 30 % and: = 75 % of predicted normal.
- •11.Clinically stable COPD in the 4 weeks prior to screening (Visit 1) and randomization (Visit 2).
- •12.Meet the concomitant medication restrictions and be expected to do so for the rest of the study.
- •13.Current and former smokers with a smoking history of = 10 pack years.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 102
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Participants who have not been Vaccinated against SARS-CoV-2 and after performing a diagnostic nucleic acid test at screening visit, this would produce a positive result.
- •2.Participants with a significant COVID-19 illness = OMS-4 within 6 months of enrolment
- •3.A history of life-threatening COPD including Intensive Care Unit admission and requiring intubation.
- •4.COPD exacerbation requiring oral steroids in the 3 months prior to randomization (Visit 2).
- •5.A history of one or more hospitalizations for COPD in the 3 months prior to screening (Visit 1).
- •6.Lower respiratory tract infection treated with antibiotics within 1 month of randomization (Visit 2).
- •7.Increased pre-BD FEV1 at randomization visit (V2) compared to Screening (V1) of = 400 mL or = 20% of V1 FEV1.
- •8.Evidence of cor pulmonale or clinically significant pulmonary hypertension.
- •9.Other respiratory disorders: Patients with a current diagnosis of asthma, active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, interstitial lung diseases, known alpha-1 antitrypsin deficiency or other active pulmonary diseases.
- •10.Previous lung resection or lung reduction surgery.
- •11.Oral therapies for COPD (e.g., theophylline, and roflumilast) in 1 month prior to screening (Visit 1) and throughout the study.
- •12.Pulmonary rehabilitation, unless such treatment has been stable for 4 weeks prior to Visit 1) and remains stable during the trial.
- •13.A history of, or reason to believe a subject has, drug or alcohol abuse within the past 3 years.
- •14.Received an experimental drug within 30 days or five half-lives of Visit 2, whichever is longer.
- •15.Women who are pregnant or breast-feeding.
- •16.Patients with a history of chronic uncontrolled disease including, but not limited to, endocrine, active hyperthyroidism, neurological, hepatic, gastrointestinal, renal, hematological, urological, immunological, or ophthalmic diseases that the Investigator believes are clinically significant.
- •17.Documented cardiovascular disease: arrhythmias, unstable angina, recent or suspected myocardial infarction within 6 months prior to screening, congestive heart failure, a history of unstable or uncontrolled hypertension, or has been diagnosed with hypertension in last 3 months.
- •18.Major surgery (requiring general anesthesia) in the 6 weeks prior to screening (Visit 1), lack of full recovery from surgery at screening (Visit 1), or planned surgery through the end of the study.
- •19.History of malignancy of any organ system within 5 years, with the exception of localized skin cancers (basal or squamous cell).
- •20.Clinically significant abnormal values for safety laboratory tests (hematology, biochemistry, or urinalysis) at screening, as determined by the Investigator.
- •21.Treatment with oxygen of more than 12 hours per day.
- •22.Any other reason that the Investigator considers makes the subject unsuitable to participate.
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