Ignite Creation Date:
2024-05-06 @ 12:43 PM
Last Modification Date:
2024-10-26 @ 1:03 PM
Study NCT ID:
NCT03834363
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-10
First Post:
2019-01-11
Brief Title:
Morphine or Fentanyl for Refractory Dyspnea in COPD
Sponsor:
Huib AM Kerstjens
Organization:
University Medical Center Groningen
Study Overview
Official Title:
Morphine or Fentanyl for Refractory Dyspnea in COPD
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MoreFoRCOPD
Brief 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 andor 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 parametersendpoints 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
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 andor 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 parametersendpoints 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None