Status:
COMPLETED
Morphine or Fentanyl for Refractory Dyspnea in COPD
Lead Sponsor:
Huib A.M. Kerstjens
Collaborating Sponsors:
Dutch Foundation for Asthma Prevention
Innovatiefonds Zorgverzekeraars
Conditions:
COPD
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 c...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 24 2024
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT03834363
Start Date
November 15 2019
End Date
August 24 2024
Last Update
June 4 2025
Active Locations (10)
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1
Wilhelmina Ziekenhuis Assen
Assen, Drenthe, Netherlands, 9401 RK
2
Elkerliek Ziekenhuis
Helmond, North Brabant, Netherlands, 5707 HA
3
Noordwest Ziekenhuisgroep Alkmaar
Alkmaar, North Holland, Netherlands, 1815 JD
4
Rode Kruis Ziekenhuis
Beverwijk, North Holland, Netherlands, 1942 LE