EUCTR2020-000571-20-CZ进行中（未招募）1 期
A Phase II, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety and Tolerability of MEDI3506 in Participants with Moderate to Severe Chronic Obstructive Pulmonary Disease and Chronic Bronchitis - FRONTIER4
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 144
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
- •Provision of informed consent
- •Participant must be 40 to 75 years of age inclusive, at hte time of signing the ICF.
- •Participants who are current or ex-smokers with a tobacco history of = 10 pack-years.
- •Participants who have a documented history of COPD for at least 1 year.
- •Participants who have a post-BD FEV1/FVC < 0.70 and a post-BD FEV1 > 30% and < 80% predicted normal value at screening. Centralized spirometry will be used for this criteria assessment.
- •Participants who have a physician confirmed participant history of chronic bronchitis as defined as presence of cough and sputum on most days for = 3 mos/yr in at least the 2 year period immediately prior to SV1 (screening).
- •Participants who have an average BCSS score of = 2 in cough and = 2 in sputum domains assessed over 14 days preceding SV3.
- •Participants who have a documented stable regimen of dual therapy or triple therapy for = 3 months prior to enrolment; there should have been no change in treatment after the previous exacerbation prior to entering into the study. Where dual therapy consists of ICS + LABA or LABA + LAMA, and triple therapy consists of ICS + LABA + LAMA.
- •Participants who have a documented history of = 1 moderate or severe AECOPD requiring systemic corticosteroids and/or antibiotics for at least 3 days duration (or 1 injection of depot formulation), or hospitalization for reason of AECOPD in the previous 24 months.
- •Body mass index within the range 18 to 40 kg/m2 (inclusive).
- •Female participants, regardless of childbearing potential, must have negative pregnancy tests.
- •Male and female participants must follow protocol contraceptive guidance.
- •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 72
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 72
排除标准
- •Participants with a positive diagnostic nucleic acid test for SARS-CoV-2 at screening. Subjects with mild or asymptomatic disease could be rescreened.
- •Participants with a significant COVID-19 illness within 6 months of enrolment
- •As judged by the investigator, any evidence of any active medical or psychiatric condition or other reason which in the investigator's opinion makes it undesirable for the participant to participate in the study.
- •Asthma as a current or past diagnosis unresolved by age 25
- •Clinically important pulmonary disease other than COPD, radiological findings, and/or laboratory findings suggestive of a respiratory disease other than COPD that is contributing to the participant's respiratory symptoms.
- •Increased pre-BD FEV1 at randomization visit (SV3) compared to Screening SV1 of = 400 mL or = 25% of SV1 FEV1.
- •Any other clinically relevant abnormal findings on physical examination, laboratory testing; or chest CT scan, which in the opinion of the investigator or medical monitor may compromise the safety of the participant in the study or interfere with evaluation of the study intervention or reduce the participant’s ability to participate in the study.
- •N-terminal pro-brain natriuretic peptide level greater than the upper limit of the laboratory reference range.
- •A family history of heart failure.
- •A LVEF < 45% measured by echocardiogram.
- •History of a clinically significant infection (viral, bacterial, or fungal) within 4 weeks.
- •History of, or a reason to believe a participant has a history of, drug or alcohol abuse within the past 2 years prior to screening.
- •Positive hepatitis C antibody hepatitis B virus surface antigen or hepatitis B virus core antibody, at screening
- •A positive test for HIV and known to have tested positive for HIV.
- •Evidence of active or untreated latent TB.
- •Change in smoking status in 12 weeks prior to enrolment or intention to change smoking status between enrolment and end of follow-up.
- •Participants currently receiving background therapy that is not approved by regulatory authorities in the country of study for COPD are not eligible for the study.
- •History of treatment with cardiotoxic medications (eg, as part of cancer therapy) including thiazolidinediones.
- •Treatment with broad spectrum antibiotic within 4 weeks prior to randomization (Day 1).
- •Receiving any of the prohibited concomitant medications as specified in the CSP.
- •Inability to perform technically acceptable spirometry.
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