Study Results
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Basic Information
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COMPLETED
PHASE4
59 participants
INTERVENTIONAL
2019-11-15
2024-08-24
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Morphine capsules and Placebo patch
Morphine retard 10 mg twice daily Placebo patch, change every three days.
Morphine Retard
Morphine retard capsules 10 mg bid.
Placebo patch
Placebo patch, change patch every three days.
Placebo capsules and Fentanyl patch
Placebo capsules twice daily Fentanyl patch 12 mcg/hr, change every three days
Fentanyl
Fentanylpatch 12 mcg/hr, change patch every three days.
Placebo oral capsule
Placebo oral capsule bid
Placebo capsules and Placebo patch
Placebo capsules twice daily Placebo patch, change every three days
Placebo patch
Placebo patch, change patch every three days.
Placebo oral capsule
Placebo oral capsule bid
Interventions
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Fentanyl
Fentanylpatch 12 mcg/hr, change patch every three days.
Morphine Retard
Morphine retard capsules 10 mg bid.
Placebo patch
Placebo patch, change patch every three days.
Placebo oral capsule
Placebo oral capsule bid
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Read, understood and signed the Informed Consent form.
* COPD GOLD class III or IV, according to GOLD criteria (Post-bronchodilation FEV/FVC \<70% and FEV1 \< 50%pred.
* Complaints of refractory dyspnea as established by patient and doctor.
* mMRC score ≥ 3.
* Life expectancy of ≥ 2 months.
* Optimized standard therapy according to Dutch LAN guideline for diagnosis and treatment of COPD.
Exclusion Criteria
* Current use of opioids for whatever indication.
* Allergy / intolerance for opioids
* Psychiatric disease, not related to severe COPD.
* Exacerbation of COPD 8 weeks prior to inclusion or between screening and randomization.
* Problematic (leading to medical help or social problems) substance abuse during the last five years.
* Active malignancy, with the exception of planocellular or basal cell carcinoma of the skin.
* eGFR \<15 ml/min
18 Years
ALL
No
Sponsors
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Dutch Foundation for Asthma Prevention
UNKNOWN
Innovatiefonds Zorgverzekeraars
OTHER
Huib A.M. Kerstjens
OTHER
Responsible Party
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Huib A.M. Kerstjens
Full professor pulmonology, head of department pulmonology and tuberculosis, principal investigator.
Principal Investigators
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Huib AM Kerstjens, MD PhD
Role: PRINCIPAL_INVESTIGATOR
University Medical Center Groningen
Locations
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Wilhelmina Ziekenhuis Assen
Assen, Drenthe, Netherlands
Elkerliek Ziekenhuis
Helmond, North Brabant, Netherlands
Noordwest Ziekenhuisgroep Alkmaar
Alkmaar, North Holland, Netherlands
Rode Kruis Ziekenhuis
Beverwijk, North Holland, Netherlands
Spaarne Gasthuis
Haarlem, North Holland, Netherlands
Medisch Spectrum Twente
Enschede, Overijssel, Netherlands
Isala Klinieken
Zwolle, Overijssel, Netherlands
Ommelander Ziekenhuis Groningen
Scheemda, Provincie Groningen, Netherlands
Ikazia Ziekenhuis
Rotterdam, South Holland, Netherlands
University Medical Center Groningen
Groningen, , Netherlands
Countries
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References
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Blinderman CD, Homel P, Billings JA, Tennstedt S, Portenoy RK. Symptom distress and quality of life in patients with advanced chronic obstructive pulmonary disease. J Pain Symptom Manage. 2009 Jul;38(1):115-23. doi: 10.1016/j.jpainsymman.2008.07.006. Epub 2009 Feb 20.
Wiseman R, Rowett D, Allcroft P, Abernethy A, Currow DC. Chronic refractory dyspnoea--evidence based management. Aust Fam Physician. 2013 Mar;42(3):137-40.
Abernethy AP, Currow DC, Frith P, Fazekas BS, McHugh A, Bui C. Randomised, double blind, placebo controlled crossover trial of sustained release morphine for the management of refractory dyspnoea. BMJ. 2003 Sep 6;327(7414):523-8. doi: 10.1136/bmj.327.7414.523.
Jennings AL, Davies AN, Higgins JP, Gibbs JS, Broadley KE. A systematic review of the use of opioids in the management of dyspnoea. Thorax. 2002 Nov;57(11):939-44. doi: 10.1136/thorax.57.11.939.
Janssen DJ, de Hosson SM, bij de Vaate E, Mooren KJ, Baas AA. Attitudes toward opioids for refractory dyspnea in COPD among Dutch chest physicians. Chron Respir Dis. 2015 May;12(2):85-92. doi: 10.1177/1479972315571926. Epub 2015 Feb 12.
Simon ST, Koskeroglu P, Gaertner J, Voltz R. Fentanyl for the relief of refractory breathlessness: a systematic review. J Pain Symptom Manage. 2013 Dec;46(6):874-86. doi: 10.1016/j.jpainsymman.2013.02.019. Epub 2013 Jun 4.
Payne R, Mathias SD, Pasta DJ, Wanke LA, Williams R, Mahmoud R. Quality of life and cancer pain: satisfaction and side effects with transdermal fentanyl versus oral morphine. J Clin Oncol. 1998 Apr;16(4):1588-93. doi: 10.1200/JCO.1998.16.4.1588.
Allan L, Hays H, Jensen NH, de Waroux BL, Bolt M, Donald R, Kalso E. Randomised crossover trial of transdermal fentanyl and sustained release oral morphine for treating chronic non-cancer pain. BMJ. 2001 May 12;322(7295):1154-8. doi: 10.1136/bmj.322.7295.1154.
Johnson MJ, Bland JM, Oxberry SG, Abernethy AP, Currow DC. Clinically important differences in the intensity of chronic refractory breathlessness. J Pain Symptom Manage. 2013 Dec;46(6):957-63. doi: 10.1016/j.jpainsymman.2013.01.011. Epub 2013 Apr 19.
Currow DC, McDonald C, Oaten S, Kenny B, Allcroft P, Frith P, Briffa M, Johnson MJ, Abernethy AP. Once-daily opioids for chronic dyspnea: a dose increment and pharmacovigilance study. J Pain Symptom Manage. 2011 Sep;42(3):388-99. doi: 10.1016/j.jpainsymman.2010.11.021. Epub 2011 Mar 31.
Jensen D, Alsuhail A, Viola R, Dudgeon DJ, Webb KA, O'Donnell DE. Inhaled fentanyl citrate improves exercise endurance during high-intensity constant work rate cycle exercise in chronic obstructive pulmonary disease. J Pain Symptom Manage. 2012 Apr;43(4):706-19. doi: 10.1016/j.jpainsymman.2011.05.007. Epub 2011 Dec 14.
Hui D, Kilgore K, Frisbee-Hume S, Park M, Liu D, Balachandran DD, Bruera E. Effect of Prophylactic Fentanyl Buccal Tablet on Episodic Exertional Dyspnea: A Pilot Double-Blind Randomized Controlled Trial. J Pain Symptom Manage. 2017 Dec;54(6):798-805. doi: 10.1016/j.jpainsymman.2017.08.001. Epub 2017 Aug 10.
van Dijk M, Mooren KJM, van den Berg JK, van Beurden-Moeskops WJC, Heller-Baan R, de Hosson SM, Lam-Wong WY, Peters L, Pool K, Kerstjens HAM. Opioids in patients with COPD and refractory dyspnea: literature review and design of a multicenter double blind study of low dosed morphine and fentanyl (MoreFoRCOPD). BMC Pulm Med. 2021 Sep 10;21(1):289. doi: 10.1186/s12890-021-01647-8.
Other Identifiers
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MoreFoRCOPD
Identifier Type: -
Identifier Source: org_study_id
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