EUCTR2018-002466-39-NL
Active, not recruiting
Phase 1
Morphine or Fentanyl for Refractory dyspnea in COPD - MoreFoRCOPD
ConditionsChronic Obstructive Pulmonary Disease, COPDMedDRA version: 20.0 Level: PT Classification code 10009033 Term: Chronic obstructive pulmonary disease System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Chronic Obstructive Pulmonary Disease, COPD
- Sponsor
- niversity Medical Center Groningen
- Enrollment
- 60
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •COPD GOLD class III or IV, according to GOLD criteria.
- •\- Post\-bronchodilatation FEV1/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.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 30
Exclusion Criteria
- •Other severe disease with chronic pain or chronic dyspnea (a non\-susbstantial 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 eight 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
Outcomes
Primary Outcomes
Not specified
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