Modified-release morphine or placebo for chronic breathlessness: the MABEL trial protocol.
ERJ Open Res
; 9(4)2023 Jul.
Article
in En
| MEDLINE
| ID: mdl-37583966
ABSTRACT
Chronic breathlessness, a persistent and disabling symptom despite optimal treatment of underlying causes, is a frightening symptom with serious and widespread impact on patients and their carers. Clinical guidelines support the use of morphine for the relief of chronic breathlessness in common long-term conditions, but questions remain around clinical effectiveness, safety and longer term (>7â
days) administration. This trial will evaluate the effectiveness of low-dose oral modified-release morphine in chronic breathlessness. 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-coronavirus disease 2019. Participants will be randomised 11 to 5â
mg oral modified-release morphine/placebo twice daily and docusate/placebo 100â
mg twice daily for 56â
days. Non-responders at Day 7 will dose escalate to 10â
mg morphine/placebo twice daily at Day 15. The primary end-point (Day 28) measure will be worst breathlessness severity (previous 24â
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 substudy will explore the adoption of morphine as a first-line pharmacological treatment for chronic breathlessness in clinical practice if effective.
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Type of study:
Clinical_trials
/
Guideline
/
Qualitative_research
Aspects:
Patient_preference
Language:
En
Journal:
ERJ Open Res
Year:
2023
Document type:
Article
Affiliation country:
United kingdom