ISRCTN10487976进行中（未招募）3 期
An international, multicentre, randomised controlled pragmatic trial of mirtazapine to alleviate breathlessness in palliative and end of life care
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 324
研究概览
简要总结
2024 Results article in https://pubmed.ncbi.nlm.nih.gov/39265600/ (added 16/09/2024)
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Current inclusion criteria as of 29/09/2020:
- •1. Aged= 18 years old
- •2. Diagnosed with:
- •2.1. Chronic obstructive pulmonary disease (COPD), and/or
- •2.2. Interstitial lung disease (ILD), including chronic fibrotic lung disease following SARS-CoV-2 infection
- •3. Breathlessness severity: Modified MRC breathlessness scale of:
- •3.1. Grade 3 (I stop for breath after walking about 100 yards or after a few minutes on level ground) or
- •3.2. 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 0 of 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):
- •7.1. Postmenopausal (no menses for 12 months without an alternative medical cause), or
- •7.2. Surgically sterile (hysterectomy, bilateral salpingectomy or bilateral oophorectomy), or
- •7.3. 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
- •Previous inclusion criteria:
- •1. Aged =18 years old
- •2. Diagnosed with:
- •2.1. Chronic obstructive pulmonary disease (COPD), and/or
- •2.2. Interstitial lung disease (ILD)
- •3. Breathlessness severity: Modified MRC breathlessness scale of:
- •3.1. Grade 3 (I stop for breath after walking about 100 yards or after a few minutes on level ground) or
- •3.2. 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 0 of 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):
- •7.1. Postmenopausal (no menses for 12 months without an alternative medical cause), or
- •7.2. Surgically sterile (hysterectomy, bilateral salpingectomy or bilateral oophorectomy), or
- •7.3. 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
排除标准
- •Current exclusion criteria as of 29/09/2020:
- •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 (e.g. myocardial infarction, unstable angina pectoris, or significant cardiac conduction disturbance) in the opinion of the identifying clinician
- •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. Uncontrolled blood pressure in the opinion of the identifying clinician
- •10. Uncontrolled diabetes mellitus in the opinion of the identifying clinician
- •11. Uncontrolled seizures, epilepsy or organic brain syndrome in the opinion of the identifying clinician
- •12. Severe depression or suicidal thoughts in the opinion of the identifying clinician
- •13. History of psychotic illness (schizophrenia, or other psychotic disturbances) in the opinion of the identifying clinician
- •14. Bipolar disorder, or a history of mania or hypomania in the opinion of the identifying clinician
- •15. 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
- •Previous exclusion criteria:
- •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 (e.g. myocardial infarction, unstable angina pectoris, or significant cardiac conduction disturbance) in the opinion of the identifying clinician
- •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 time
研究者
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