EUCTR2019-002001-21-IE
Active, not recruiting
Phase 1
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 sites324 target enrollmentMarch 10, 2020
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- niversity College Dublin
- Enrollment
- 324
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
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 (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
Outcomes
Primary Outcomes
Not specified
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