EUCTR2019-002001-21-DE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: 2020年8月25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), and/or
- •Interstitial lung disease (ILD), including chronic fibrotic lung disease following SARS-CoV-2 infection
- •3.Breathlessness severity: Modified MRC (mMRC) 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 (see section 9.3.3 of the protocol for guidance)
- •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: 0
- •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 acute cardiac events within 3 months prior to randomisation (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
- •8.Patients with known renal impairment in the opinion of the identifying clinician
- •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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