Chronic Obstructive Pulmonary Disease MedDRA version: 17.1 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 100000004855
Conditions
Interventions
Trade Name: Morfine HCl retard CF 10 mg
Product Name: Morfine HCl retard CF 10 mg
Product Code: RVG 22941
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Capsule, hard
Route of adminis
Sponsors
Maastricht University
Eligibility
Sex/Gender
All
Inclusion 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; • 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1.1) to study whether and to what extent oral administration of morphine SR improves health-related quality of life among patients with advanced COPD; 1.2) to explore whether and to what extent oral administration of morphine SR leads to adverse respiratory effects in patients with advanced COPD. ;Secondary Objective: 2.1) to study whether and to what extent oral administration of morphine SR improves exercise capacity among patients with advanced COPD; 2.2) to study the relationship between severity and description of breathlessness and response to morphine SR among patients with advanced COPD; 2.3) to analyse the cost-effectives of oral administration of morphine SR in patients with advanced COPD. ;Primary end point(s): • Change in disease-specific health-related quality of life (COPD Assessment Test (CAT); • Change in respiratory parameters: arterial blood gas (partial pressure of carbon dioxide (pCO2); partial pressure of oxygen (pO2); respiratory rate; pulse oximetric saturation (SpO2); transcutaneous carbon dioxide (PtcCO2); Overnight oximetry; lung function. ;Timepoint(s) of evaluation of this end point: Baseline, 1, 2 and 4 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Baseline, 1, 2 and 4 weeks;Secondary end point(s): • Change in exercise capacity (6 minute walking distance test); • Change in functional capacity (care dependency (Care Dependency Scale) and mobility (Timed ‘Up & Go’ test). • sensory and affective dimensions of dyspnea (Multidimensional Dyspnea Profile); • impact of dyspnea (modified Pulmonary Functional Status and Dyspnea Questionnaire); • dyspnea (Numeric Rating Scale) • adverse affects (including nausea, vomiting, constipation, and drowsiness) • compliance; • exacerbations (defined as an acute event characterized by a worsening of the patient’s respiratory symptoms that is beyond normal day-to-day variations and leads to a change in medication). • Costs and cost-effectiveness | — |
Countries
Netherlands
Contacts
Public ContactD. Janssen
Centre of expertise for palliative care, Maastricht UMC+
Outcome results
None listed