Morphine or Fentanyl for Refractory dyspnea in COPD

Recruiting

Conditions: chronic bronchitis and emphysema.
COPD (Chronic Obstructive Pulmonary Disease)
10006436

Registration Number: NL-OMON52406

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 60

Inclusion Criteria

• Age >=40 years
• Read, understood and signed the Informed Consent form
• 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.

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is change in average dyspnea sensation as measured on the<br /><br>Numeric Rating Scale for Dyspnea, mean of daily measurements for days 7 to 14<br /><br>of each treatment period.</p><br>

Secondary Outcome Measures