COPD and breathless even with current treatment
The Palliative Care Clinical Studies Collaborative are currently looking for people who have COPD (emphysema) and continue to feel breathless even with current treatment.
Breathlessness can be a frightening and overwhelming problem that is difficult to treat. For many people, breathlessness remains when all the underlying causes of breathlessness have been optimally managed (“chronic breathlessness”).
Breathlessness in these circumstances often occurs at rest or doing routine things like showering or preparing meals. This is a problem affecting tens of thousands of Australians every day and their carers, often for years at a time.
Evidence from a number of clinical studies 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 a benefit, no response or side effects.
This study will include people with chronic obstructive pulmonary disease (COPD; also known as emphysema) and significant breathlessness, and will explore several important questions:
- Are regular, low doses of morphine at four possible doses over 3 weeks more effective than placebo medication (containing no active ingredient) 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?
During this study, participants will receive once daily extended release morphine, or placebo in addition to their usual medication for up to 3 weeks at increasing doses. Some people experience side effects, most frequently constipation, when taking opioids. Participants will therefore be given regular medications to help their bowels to work normally if they are on morphine. Participants who are on placebo will take two similarly looking placebo laxative tablets each morning. All participants will be provided with additional medications to help their bowels work effectively (docusate with senna) as needed throughout the study.
Other side effects can include some drowsiness, nausea or difficulty concentrating, especially when the medication is first started or when doses are changed. These side effects usually pass quickly even when the medication is continued.
Eligible participants are adults with documented COPD and severe breathlessness, who agree to take part in the study, and who meet all the study participation criteria.
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.
This study will explore a regular low dose of a medication called extended release morphine. Although extended release morphine is used frequently for pain control and has been evaluated for its relief of breathlessness in advanced disease, there has been no study of its safety, costs and net clinical effects that have thus far been accepted by the regulatory authorities to enable access in the community for people with COPD.
Participants will be allocated to receive three weeks of extended release morphine or placebo capsules. 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. If there is a need to know what the participant is on, this information can be quickly found.
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.
For further information please contact Dr Anu Krishnan on 0405 506 483 or via email at firstname.lastname@example.org