Morphine or Fentanyl for Refractory Dyspnea in COPD

Launched by HUIB A.M. KERSTJENS · Feb 6, 2019

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of two medications, morphine and fentanyl, for treating severe shortness of breath (called refractory dyspnea) in patients with chronic obstructive pulmonary disease (COPD). Many people with advanced COPD struggle with this breathing difficulty, which can greatly affect their quality of life. The researchers want to find out if fentanyl patches, which are applied to the skin, are as effective as morphine tablets in reducing shortness of breath, while also causing fewer side effects.

To participate in the study, individuals must be at least 40 years old, have a diagnosis of severe COPD, and experience significant breathing difficulties despite receiving standard treatments. Participants will be randomly assigned to receive either morphine, fentanyl, or a placebo (a dummy treatment with no active medication) in different combinations. Throughout the trial, they will be monitored for changes in their breathing, quality of life, and any side effects from the medications. This study aims to provide more information on the use of opioids for managing severe dyspnea in COPD patients, which may help improve treatment options in the future.

Gender

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Eligibility criteria

• Inclusion Criteria:
• • Age ≥ 40 years.
• • 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:
• • Other severe disease with chronic pain or chronic dyspnea (a non substantial component of left sided heart failure is acceptable).
• • 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