EUCTR2019-002001-21-IT
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 enrollmentJune 8, 2021
ConditionsRefractory breathlessness in patients diagnosed with chronic obstructive pulmonary disease (COPD) or interstitial lung disease (ILD).MedDRA version: 21.1Level: LLTClassification code 10009032Term: Chronic obstructive lung diseaseSystem Organ Class: 100000004855Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
DrugsMirtazapine
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
- niversity College Dublin
- Enrollment
- 324
- Status
- Active, not recruiting
- Last Updated
- 4 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), 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
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
Outcomes
Primary Outcomes
Not specified
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