Abstract / Description of output
This is a multicentre, parallel group, double-blind, randomised, placebo-controlled trial. Participants [n=158] will be opioid-naïve with chronic breathlessness due to heart or lung disease, cancer or post-COVID-19. Participants will be randomised 1:1 to 5 mg oral modified-release morphine/placebo twice daily and docusate/placebo 100 mg twice daily for 56 days. Non-responders at Day 7 will dose escalate to 10 mg morphine/placebo twice daily at Day 15.
The primary endpoint (Day 28) measure will be worst breathlessness severity (past 24 h). Secondary outcome measures include worst cough, distress, pain; functional status; physical activity; quality of life; and early identification and management of morphine-related side effects. At Day 56, participants may opt to take open-label, oral modified-release morphine as part of usual care and complete quarterly breathlessness and toxicity questionnaires.
The study is powered to be able to reject the null hypothesis and an embedded normalisation process theory-informed qualitative sub-study will explore the adoption of morphine as a first-line pharmacological treatment for chronic breathlessness in clinical practice if effective.