EUCTR2019-002001-21-IT进行中（未招募）1 期
BETTER-B: BETter TreatmEnts for Refractory Breathlessness. An International, Multicentre, Randomised Controlled Pragmatic Trial of Mirtazapine to alleviate Breathlessness in Palliative and End of Life Care. - BETTER-B
niversity College Dublin0 个研究点目标入组 324 人开始时间: 2021年6月8日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 324
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.Aged = 18 years old
- •2.Diagnosed with:
- •Chronic obstructive pulmonary disease (COPD), or
- •Interstitial lung disease (ILD) including chronic fibrotic lung disease following SARS-CoV-2 infection
- •3.Breathlessness severity: Modified MRC breathlessness scale of:
- •grade 3 (I stop for breath after walking about 100 yards or after a few minutes on level ground) or
- •Grade 4 (I am too breathless to leave the house or I am breathless when dressing or undressing)
- •4.On optimal treatment of the underlying condition in the opinion of the identifying clinician
- •5.Management of the underlying condition unchanged for the previous 2 weeks
- •6.Reversible causes of breathlessness optimally treated in the opinion of the identifying clinician
- •7.If female, must be (as documented in patient notes):
- •a)postmenopausal (no menses for 12 months without an alternative medical cause), or
- •b)surgically sterile (hysterectomy, bilateral salpingectomy or bilateral oophorectomy), or
- •c)using acceptable contraception (which must be continued for 7 days after the last dose of IMP)
- •8.Able to complete questionnaires and trial assessments
- •9.Able to provide written informed consent
- •Caregiver eligibility:
- •Caregivers will be identified by an included patient participant as the
- •person closest to them, providing the patient participant is willing for
- •them to be approached.
- •Caregivers must meet all of the following criteria to be eligible:
- •1.Identified by an included patient as the person closest to them
- •2.Aged =18 years old
- •3.Able to complete questionnaires and assessments
- •4.Able to provide written informed consent
- •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 162
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 162
排除标准
- •1.Existing antidepressant use, or other serotonergic active substances
- •(e.g. linezolid, St John's wort)
- •2.Known contraindication to mirtazapine
- •3.Hypersensitivity to the active substance or to any of the components of
- •mirtazapine or placebo (e.g. lactose intolerance)
- •4.Australia modified Karnofsky Performance Scale =40
- •5.Pregnant or breast-feeding women. For women of childbearing
- •potential (those not post-menopausal or surgically sterile) this must be
- •confirmed by a pregnancy test (urine) within 7 days prior to
- •randomisation
- •6.Patients with known cardiovascular disease or acute cardiac events
- •within 3 months prior to randomisation (e.g. myocardial infarction,
- •unstable angina pectoris, or significant cardiac conduction disturbance)
- •7.Patients with jaundice or known hepatic impairment in the opinion of
- •the identifying clinician (e.g. bilirubin >25micromol/L, and AST and ALT
- •>2 times upper limit of normal)
- •8.Patients with known renal impairment in the opinion of the identifying
- •clinician (e.g. creatinine >132micromol/L and eGFR
- •<30mL/min/1.73m2)
- •9.Patients with uncontrolled blood pressure in the opinion of the
- •identifying clinician
- •10.Patients with uncontrolled diabetes mellitus in the opinion of the
- •identifying clinician
- •11.Patients with uncontrolled seizures, epilepsy or organic brain
- •syndrome in the opinion of the identifying clinician
- •12.Patients with severe depression or suicidal thoughts in the opinion of
- •the identifying clinician
- •13.Patients with a history of psychotic illness (schizophrenia, or other
- •psychotic disturbances) in the opinion of the identifying clinician
- •14.Patients with bipolar disorder, or a history of mania or hypomania in
- •the opinion of the identifying clinician
- •15.Patients currently enrolled in another interventional trial
- •16.Patients with known congenital QT prolongation or family history for
- •QT prolongation
- •17.Use of medicines that cause QT prolongation such as macrolides and
- •typical antipsychotics (unless required in low-dose to relieve nausea,
- •e.g. haloperidol =5mg/24h, levomepromazine =25mg/24h)
- •18.Patients with a known history of suicide-related events
研究者
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