Opioids for severe Shortness of Breath in Chronic Obstructive Pulmonary Disease

Phase 1

• Conditions: Chronic Obstructive Pulmonary Disease, COPD; MedDRA version: 20.0 Level: PT Classification code 10009033 Term: Chronic obstructive pulmonary disease System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2018-002466-39-NL
• Lead Sponsor: niversity Medical Center Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-11-19
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 60

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Main Objective: We will investigate the following hypothesis: Fentanyl patches provide reduction of dyspnea compared to placebo, comparable to morphine, and with less side effects than morphine. <br> ;Primary end point(s): The primary endpoint is change in dyspnea sensation;Timepoint(s) of evaluation of this end point: This endpoint will be evaluated when the last participant has ended the treatment period.;<br> Secondary Objective: With this Dutch multi-center study we 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.<br> And we will develop and evaluate educational material about opioid use for dyspnea in COPD to greatly enhance the implementation of opioids for this indication.<br>

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Secondary endpoints are change in HR-QoL, anxiety, sleep quality, hypercapnia and the number and seriousness of side effect.;Timepoint(s) of evaluation of this end point: These secundary endpoints will be evaluated when the last participant has ended the treatment period.