Morphine for palliative treatment of refractory dyspnea in patients with advanced COPD: benefits and respiratory adverse effects

Completed

Conditions: COPD
Chronic Obstructive Pulmonary Disease
10006436

Registration Number: NL-OMON47485

Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 124

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 treatment with a combination of a long-acting muscarinic antagonist and an ultra-long-acting *-agonist; ;* Grade 2, 3 or 4 dyspnea on the mMRC; ;* 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);
* age under 18
* 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Health-related quality of life;<br /><br>- Respiratory parameters.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Functional capacity;<br /><br>- The relationship between response to morphine and severity of dyspnea and<br /><br>descriptors of breathlessness will be explored;<br /><br>- Cost-effectiveness.</p><br>