ISRCTN32236160
Completed
未知
BETter TreatmEnts for Refractory Breathlessness: A feasibility study of the use of mirtazapine for refractory breathlessness
Kings College Hospital NHS Foundation Trust0 sites64 target enrollmentJune 13, 2016
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Kings College Hospital NHS Foundation Trust
- Enrollment
- 64
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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)
Investigators
Eligibility Criteria
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
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
Outcomes
Primary Outcomes
Not specified
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Completed
Not Applicable
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