Morphine for Treatment of Dyspnea in Patients With COPD
Status:
Completed
Trial end date:
2019-07-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 4
Details
Lead Sponsor:
Maastricht University Medical Center
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development