Morphine for Treatment of Dyspnea in Patients With COPD

• Status: Completed
• Trial end date: 2019-07-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Maastricht University Medical Center
• Collaborator: ZonMw: The Netherlands Organisation for Health Research and Development
• Treatments: Morphine

Criteria

Inclusion Criteria:

• Diagnosis of COPD according to the current Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease (GOLD);

• Optimal pharmacological treatment, including including treatment with a combination of a long-acting muscarinic antagonist and an ultra-long-acting β-agonist;

• Grade 3 or 4 dyspnea on the mMRC dyspnea scale;

• Optimal non-pharmacological treatment defined as completed a comprehensive pulmonary rehabilitation program.

Exclusion Criteria:

• History of substance misuse;

• Exacerbation of COPD within two weeks of study enrolment;

• Waiting list for lung transplantation;

• Pregnant or childbearing potential not using contraception;

• Renal failure (creatinine clearance <15mL/min);

• Not being able to read or fill in the questionnaires or diary;

• Allergy for morphine or its excipients;

• Concomitant use of irreversible MAO blockers;

• Use of opioids;

• History of convulsions;

• Head injury;

• Intestinal obstruction;

• Gastroparesis;

• Liver disease.