Breathlessness is an overwhelming symptom affecting tens of thousands of Australians every
day. For many people, it persists even when all the underlying causes have been optimally
managed (chronic breathlessness). In these circumstances, it often occurs at rest or with
minimal exertion.
Evidence from a number of clinical studies suggests that a small, regular dose of morphine
helps to reduce safely the sensation of breathlessness. However, it is not well established
which patients derive more benefit and what is the net clinical effect of this treatment
(weighing benefits and harms).
This is a phase III, multi-site, randomised, double-blind, placebo-controlled trial with
patients with chronic obstructive pulmonary disease (COPD) and severe chronic breathlessness
which will explore several important questions:
- Are regular, low doses of morphine at four possible doses over 3 weeks more effective
than placebo at improving breathlessness?
- Does increasing the dose in people who already are experiencing some benefit provide
even greater reduction in worst breathlessness?
- Does the medication have any effect on daily activity and quality of life?
- What are the common or serious side effects of this intervention?
- Does the benefit from the medication outweigh the side effects it produces?
- Are there specific characteristics of people who are more likely to receive benefit from
extended release morphine?
Participants will receive once daily extended release morphine (plus laxative, docusate with
senna), or placebo (placebo laxative) in addition to their usual medication for up to 3 weeks
at increasing doses.
Participants will have a medical interview and physical examination to collect some general
health information, and baseline measurements including; daily activity, symptoms, and
quality of life. A small amount of blood may be required to check eligibility. Further blood
samples may be taken at week 1 and 3 to enable testing on how individuals respond to opioids,
further consent will be obtained for these samples.
Data on benefits, side effects, and medical care will be collected during comprehensive
weekly visits. Participants will also fill out a simple diary twice daily for weeks one to
three of the study, and for one day each week during an optional 6 month extension stage.
The outcome of this study may enable better management of symptoms and activity in people
COPD with medicines that are shown to be effective and safe.