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

King's College London0 sites324 target enrollmentJanuary 2, 2020

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Refractory breathlessness in patients diagnosed with chronic obstructive pulmonary disease (COPD) or interstitial lung disease (ILD).
Sponsor: King's College London
Enrollment: 324
Status: Active, Not Recruiting
Last Updated: 5 years ago

No summary available.

Registry

who.int

Start Date

January 2, 2020

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•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

•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