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Morphine for Treatment of Dyspnea in Patients With COPD

NCT02429050 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2019-09-04

No results posted yet for this study

Summary

Dyspnea is the most reported symptom of patients with advanced Chronic Obstructive Pulmonary Disease (COPD) and is undertreated. Morphine is an effective treatment for dyspnea and is recommended in clinical practice guidelines, but questions concerning benefits and concerns about respiratory adverse effects remain. For example, the effect on health-related quality of life and functional capacity is unknown. In one-third of the patients oral sustained release morphine (morphine SR) doesn't relieve dyspnea and it remains unknown whether severity and descriptors of breathlessness may predict a response to morphine. Finally, cost-effectiveness of morphine SR in this patient group is unknown. Therefore, prescription of morphine to patients with COPD is limited.

Objectives of this double blind randomized controlled trial are to study the effect of oral administration of morphine SR on health-related quality of life, respiratory adverse effects, and functional capacity; to explore whether description and severity of breathlessness are related with a clinically relevant response to morphine and to analyse the cost-effectiveness of morphine SR. The study population will consist of 124 clinically stable outpatients with COPD and severe dyspnea despite optimal pharmacological and non-pharmacological treatment.

Conditions

  • Pulmonary Disease, Chronic Obstructive

Interventions

DRUG

sustained release morphine

Patients will receive morphine SR 10mg two to three times daily or placebo. Hard gelatin capsules of size AA in Swedish orange containing one morphine SR tablet 10 mg per capsule will be produced. Morphine SR has a marketing authorisation for pain and will be used according to current Dutch and international guidelines for treatment of dyspnea.

DRUG

placebo

Patients in the control group will receive placebo, consisting of microcrystalline cellulose (FMC BioPolymer). Hard gelatin capsules of size AA in Swedish orange containing microcrystalline cellulose will be produced.

Sponsors & Collaborators

  • ZonMw: The Netherlands Organisation for Health Research and Development

    collaborator OTHER

  • Maastricht University Medical Center

    lead OTHER

Principal Investigators

  • Daisy JA Janssen, MD, PhD · Maastricht UMC

  • E. FM Wouters, MD, PhD · Maastricht UMC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-16
Primary Completion
2019-03-06
Completion
2019-07-01

Countries

  • Netherlands

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02429050 on ClinicalTrials.gov