Better treatments for refractory breathlessness

Not Applicable

Completed

• Conditions: Specialty: Respiratory disorders, Primary sub-specialty: Respiratory disorders; UKCRC code/ Disease: Respiratory/ Other diseases of the respiratory system; Respiratory; Refractory breathlessness

• Registration Number: ISRCTN32236160
• Lead Sponsor: Kings College Hospital NHS Foundation Trust

Brief Summary

2020 Results article in https://www.ncbi.nlm.nih.gov/pubmed/31915308 results (added 10/01/2020) 2020 Results article in https://www.ncbi.nlm.nih.gov/pubmed/32087745 qualitative results (added 24/02/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-06-13
• Study Completion: 2018-12-26
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

1. Male or female aged = 18 years old
2. Modified MRC dyspnoea scale grade 3 or 4
3. Diagnosis of either:
3.1. Cancer
3.2. Chronic obstructive pulmonary disease (COPD)
3.3. Interstitial lung disease (ILD)
3.4. Chronic heart failure (New York Heart Association class III or IV)
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 1 week
6. Reversible causes of breathlessness optimally treated in the opinion of the identifying clinician
7. Expected prognosis of =2 months
8. If female and of child-bearing potential, must agree to use adequate contraception
9. Able to complete questionnaires and trial assessments
10. Able to provide written informed consent

Exclusion Criteria

1. Existing antidepressant use
2. Known contraindication to mirtazapine
3. Hypersensitivity to the active substance or to any of the components of the mirtazapine or placebo (e.g. lactose intolerance)
4. Australia modified Karnofsky Performance Scale =40
5. Pregnant or breast-feeding women
6. Patients with acute cardiac events within 3 months of randomisation (myocardial infarction, unstable angina pectoris, or significant cardiac conduction disturbance)
7. Patients with known hepatic impairment
8. Patients with known renal impairment
9. Patients with uncontrolled blood pressure
10. Patients with uncontrolled diabetes mellitus
11. Patients with uncontrolled seizures, epilepsy or organic brain syndrome
12. Patients with severe depression or suicidal thoughts
13. Patients with a history of psychotic illness (schizophrenia, bipolar disorder, mania or hypomania, or other psychotic disturbances)

Study & Design

• Study Type: Interventional
• Study Design: Not specified