Morphine or Fentanyl for Refractory Dyspnea in COPD
Status:
Recruiting
Trial end date:
2022-04-01
Target enrollment:
Participant gender:
Summary
Rationale: The most important complaint in severe COPD is dyspnea which is associated with a
diminished exercise tolerance, reduced quality of life and can lead to anxiety and
depression. If dyspnea continues to exist despite optimal therapy it is called refractory
dyspnea. There is evidence that morphine is effective and can safely be prescribed for
treating refractory dyspnea.
However, a Dutch study recently showed that few pulmonologists actually prescribe opioids for
this indication. The main reasons for this are concerns about side effects and respiratory
insufficiency as well as negative emotions for the patient and families at the thought of
using morphine.
Most studies investigating opioids for treatment of dyspnea are conducted with morphine
tablets, and only a part of these patients suffered from COPD. To our knowledge there has not
been a randomized controlled trial investigating fentanyl patches for refractory dyspnea in
COPD patients. However, studies comparing fentanyl and morphine in pain management show that
patients may prefer fentanyl patches and have less problems with obstipation.
Objective: There are three main objectives for this study.
First, the investigators will investigate the following hypothesis: Both fentanyl and
morphine provide a reduction of dyspnea which is better than placebo. Fentanyl has less side
effects than morphine.
Secondly, with this Dutch multi-center study the investigators would like to enlarge the
evidence base and contribute to the experience with opioids for refractory dyspnea in COPD
thereby greatly facilitating its implementation in the Netherlands.
Finally, the investigators will develop and evaluate educational material about opioid use
for dyspnea in COPD.
Study design: This is a multi-center double blind, double-dummy cross-over randomized
placebo-controlled trial with three study arms. A total of 60 COPD patients will be included
in this study.
Participants will be treated sequentially with three combinations of medication and/or
placebo medication in a random order. They will receive either a Fentanyl patch in
combination with placebo tablets, a placebo patch with Morphine Slow release tablets or a
placebo patch with placebo tablets. Main study parameters/endpoints: The primary endpoint is
change in dyspnea sensation Secondary endpoints are change in HR-QoL, anxiety, sleep quality,
hypercapnia and the number and seriousness of side effect.
Phase:
Phase 4
Details
Lead Sponsor:
Huib A.M. Kerstjens
Collaborators:
Dutch Foundation for Asthma Prevention Innovatiefonds Zorgverzekeraars