EUCTR2019-002001-21-IE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3月10日最近更新:
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/ori
- •- 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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