Opioids for Refractory Breathlessness in Chronic Obstructive Pulmonary Disease
Status:
Withdrawn
Trial end date:
2018-04-01
Target enrollment:
Participant gender:
Summary
Breathlessness, the sensation of breathing discomfort, is a major problem in people with
chronic obstructive pulmonary disease (COPD). Breathlessness that persists despite optimal
management of the underlying disease(s) is said to be refractory.
Preliminary evidence suggests that a small, regular dose of morphine helps to reduce safely
the sensation of breathlessness. However, this research on morphine for breathlessness has
not defined the best way to adjust the dose of the medication, or refined which people are
most likely to have benefit, no response or side effects.
This is a randomized, double-blind phase III trial in people with COPD and significant
refractory breathlessness, which will explore several important questions:
- Are regular, low dose opioids (morphine) at four possible doses over 3 weeks more
effective than placebo medication (containing no active ingredient) at improving
breathlessness?
- Does the medication have any effect on daily activity, breathlessness, and quality of
life?
- What are the common side effects of this intervention?
- Does the benefit from the drug outweigh the side effects it produces?
- Are there specific characteristics of people who are more likely to receive benefit from
sustained release morphine?
Participants will be allocated to receive three weeks of morphine sulfate (and laxative,
docusate with senna), or placebo (and placebo laxative). The dose of morphine may be
increased each week for weeks two and three. All medicines will appear the same (blinded) and
neither the doctor nor the participant will know which medication the participant is
receiving.
Participants will have a medical interview, 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 3 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.