Opioids for severe Shortness of Breath in Chronic Obstructive Pulmonary Disease

Morphine or Fentanyl for Refractory dyspnea in COPD - MoreFoRCOPD

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-002466-39-NL

Enrollment

Registered

2018-11-19

Start date

2019-04-17

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Interventions

Product Name: Morphine hydrochloride trihydrate Pharmaceutical Form: Tablet Pharmaceutical form of the placebo: Tablet Route of administration of the pl

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • COPD GOLD class III or IV, according to GOLD criteria. - Post-bronchodilatation FEV1/FVC =65 years) yes F.1.3.1 Number of subjects for this age range 30

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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. ;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.; 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. 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.	—

Measure

Time frame

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. ;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.; 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. 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.

—

Secondary

Measure	Time frame
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.	—

Countries

Netherlands

Contacts

Public ContactMarlies van Dijk

University Medical Center Groningen

00315012357

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026