Breathlessness Exertion and Morphine Sulphate

Launched by FLINDERS UNIVERSITY · Mar 24, 2016

Keywords

ClinConnect Summary

Background: Three hundred thousand (300,000) Australians are breathless at rest or on minimal exertion, often for years, despite optimal treatment of the underlying cause(s). This includes more than 70,000 people who are too breathless to leave their homes often for long periods of time. Underlying causes for such severe and ongoing breathlessness include chronic obstructive pulmonary disease (COPD), interstitial lung disease, heart failure, neurodegenerative diseases such as motor neurone disease and cachexia from any cause. The prevalence of chronic refractory breathlessness will continue...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 18 years of age or older.
• • Physician diagnosed COPD confirmed by spirometry with the most recent result available defined as a prior post-bronchodilator FEV1/FVC \< 0.7 in accordance with the GOLD 2014 criteria.
• • Respiratory physician confirmed optimisation of treatment of COPD.
• • On stable medications relating to the optimal treatment of COPD or its symptomatic management over the prior week except routine "as needed" medications.
• • Breathlessness of a level three (3) or four (4) on the modified Medical Research Council (mMRC) breathlessness scale.
• • worst breathlessness intensity in the previous 24 hours was at least 3/10 on a 0-10 numerical rating scale (NRS).
• • English speaking with sufficient reading and writing ability to complete the study questionnaires
• • Assessed as competent (using St Louise University Mental Status Examination (SLUMS) score of 27/30 for people whose highest level of education was high school, and 25/30 for people who did not complete high school).
• • Able and willing to give written informed consent.
• Exclusion Criteria:
• • On any opioid for breathlessness in the previous seven (7) days.
• • On regularly prescribed opioid medications for other conditions, including codeine preparations at or above 8mg oral morphine equivalent daily dose (MEDD) in the previous seven (7) days.
• • History of adverse reactions to any of the study medications or constituents in the placebo;
• • Australian-modified Karnofsky performance score (AKPS) less than 50 at the beginning of the study.
• • Respiratory or cardiac event in the previous one week (excluding upper respiratory tract infections). Illness must have resolved completely prior to baseline evaluation, as judged by the person's treating physician.
• • Evidence of respiratory depression with resting respiratory rate \<8/min.
• • Documented central hypoventilation syndrome.
• • Current history of abuse of alcohol, or recent history of substance misuse.
• • Uncontrolled nausea, vomiting or evidence of a gastrointestinal tract obstruction.
• • Renal dysfunction with creatinine clearance calculated (MDRD) less than 20 mls/minute.
• • Evidence of severe hepatic impairment defined as transaminases or bilirubin \>4x normal (Excluding Gilbert's syndrome)
• • Pregnant or breastfeeding.