Treatment of breathlessness with morphine in patients with COPD: benefits and safety

Phase 1

• Conditions: Chronic Obstructive Pulmonary Disease; MedDRA version: 17.1Level: LLTClassification code 10010952Term: COPDSystem Organ Class: 100000004855; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2014-004899-35-NL
• Lead Sponsor: Maastricht University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-01-15
• Last Update Posted: 15 June 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

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;
• Grade 3 or 4 dyspnea on the mMRC;
• optimal non-pharmacological treatment defined as completed a comprehensive pulmonary rehabilitation program.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 70
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified