BETTER-B (Aus): Better treatments for refractory breathlessness
- Conditions
- Refractory breathlessness in patients with a chronic obstructive pulmonary disease (COPD) or interstitial lung disease (ILD)RespiratoryChronic obstructive pulmonary disease (COPD), interstitial lung disease (ILD)
- Registration Number
- ISRCTN15751764
- Lead Sponsor
- niversity of Technology Sydney
- Brief Summary
2024 Results article in https://pubmed.ncbi.nlm.nih.gov/39265600/ (added 16/09/2024)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 20
Patients:
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 the section 9.3.3 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
Carers:
10. Identified by an included participant as the person closest to them
11. Aged =18 years
12. Able to complete questionnaires and assessments
13. Able to provide written informed consent
Patients:
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. 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. 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. Known renal impairment in the opinion of the identifying clinician (e.g. creatinine >132micromol/L and eGFR <30mL/min/1.73m2 x)
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
Carers:
There are no specific exclusion criteria for caregivers.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Self-reported worst breathlessness over the last 24 hours at day 56 post start of treatment as assessed by numerical rating scale (NRS, 0=no breathlessness to 10=worst possible breathlessness)
- Secondary Outcome Measures
Name Time Method