BETTER-B: Better Treatments for Refractory Breathlessness.

Phase 1

• Conditions: Refractory breathlessness in patients diagnosed with chronic obstructive pulmonary disease (COPD) or interstitial lung disease (ILD).; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2019-002001-21-GB
• Lead Sponsor: King's College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-01-02
• Last Update Posted: 7 September 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 324

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

7.If female, must be (as documented in patient notes):
a)postmenopausal (no menses for 12 months without an alternative medical cause), or
b)surgically sterile (hysterectomy, bilateral salpingectomy or bilateral oophorectomy), or
c)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

Caregiver eligibility:
Caregivers will be identified by an included patient participant as the person closest to them, providing the patient participant is willing for them to be approached.

Caregivers must meet all of the following criteria to be eligible:
1.Identified by an included patient as the person closest to them
2.Aged =18 years old
3.Able to complete questionnaires and assessments
4.Able to provide written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 162
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 162

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 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

11.Patients with uncontrolled seizures, epilepsy or organic brain syndrome in the opinion of the identifying clinician

12.Patients with severe depression or suicidal thoughts in the opinion of the identifying clinician

13.Patients with a history of psychotic illness (schizophrenia, or other psychotic disturbances) in the opinion of the identifying clinician

14.Patients with bipolar disorder, or a history of mania or hypomania in the opinion of the identifying clinician

15.Patients 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified