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Morphine for Treatment of Dyspnea in Patients With COPD (MORDYC)

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ClinicalTrials.gov Identifier: NCT02429050
Recruitment Status : Completed
First Posted : April 29, 2015
Last Update Posted : September 4, 2019
Sponsor:
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by (Responsible Party):
Maastricht University Medical Center

Brief 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.


Condition or disease Intervention/treatment Phase
Pulmonary Disease, Chronic Obstructive Drug: sustained release morphine Drug: placebo Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Morphine for Palliative Treatment of Refractory Dyspnea in Patients With Advanced COPD: Benefits and Respiratory Adverse Effects
Actual Study Start Date : November 16, 2016
Actual Primary Completion Date : March 6, 2019
Actual Study Completion Date : July 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: intervention
sustained release morphine
Drug: sustained release morphine
Patients will receive morphine SR 10mg two to three times daily or placebo. Hard gelatin capsules of size AA in Swedish orange containing one morphine SR tablet 10 mg per capsule will be produced. Morphine SR has a marketing authorisation for pain and will be used according to current Dutch and international guidelines for treatment of dyspnea.

Placebo Comparator: control
placebo
Drug: placebo
Patients in the control group will receive placebo, consisting of microcrystalline cellulose (FMC BioPolymer). Hard gelatin capsules of size AA in Swedish orange containing microcrystalline cellulose will be produced.




Primary Outcome Measures :
  1. Disease-specific health-related quality of life (COPD Assessment Test (CAT)) [ Time Frame: sixteen weeks ]
    Change in disease-specific health-related quality of life in four weeks measured with CAT

  2. Change in partial pressure of CO2 (pCO2) [ Time Frame: four weeks ]
    Change in pCO2 in four weeks

  3. Change in partial pressure of O2 (pO2) [ Time Frame: four weeks ]
    Change in pO2 in four weeks

  4. Respiratory rate [ Time Frame: four weeks ]
    Change in respiratory rate in four weeks

  5. Pulse oximetric saturation (SpO2) [ Time Frame: four weeks ]
    Change in SpO2 in four weeks

  6. Transcutaneous carbon dioxide (PtcCO2) [ Time Frame: four weeks ]
    Change in PtcCO2 in four weeks

  7. Oxygen saturation during the night [ Time Frame: four weeks ]
    Change in oxygen saturation during the night in four weeks using overnight oximetry


Secondary Outcome Measures :
  1. distance walked in 6 Minute Walking Test (6-MWT) [ Time Frame: four weeks ]
    Change in exercise capacity in four weeks measured with 6-MWT

  2. Care dependency (Care Dependency Scale (CDS) [ Time Frame: four weeks ]
    Change in care dependency in four weeks measured with CDS

  3. Mobility (Timed 'Up & Go' (TUG) test) [ Time Frame: four weeks ]
    Change in mobility in four weeks measured with TUG test.

  4. Sensory and affective dimensions of dyspnea (Multidimensional Dyspnea Profile (MDP) [ Time Frame: four weeks ]
    Sensory and affective dimensions of dyspnea in four weeks measured with MDP

  5. Impact of dyspnea (Pulmonary Functional Status and Dyspnea Questionnaire, PFSDQ-M) [ Time Frame: four weeks ]
    Change in impact of dyspnea in four weeks measured with PFSDQ-M

  6. Severity of dyspnea (Numeric Rating Scale (NRS) [ Time Frame: sixteen weeks ]
    Change in severity of dyspnea in four weeks measured with NRS

  7. Daytime sleepiness (Epworth Sleep Questionnaire) [ Time Frame: four weeks ]
    Change in level of daytime sleepiness in four weeks measured with Epworth Sleep Questionnaire

  8. Cognition (Montreal Cognitive Assessment, (MoCA) [ Time Frame: four weeks ]
    Change in cognition in four weeks measured with MoCA

  9. Number of patients with adverse effects [ Time Frame: sixteen weeks ]
    Adverse effects, including nausea, vomiting, constipation, drowsiness

  10. Intake of medication [ Time Frame: four weeks ]
    Number of missed medication intakes in four weeks

  11. Number of exacerbations [ Time Frame: sixteen weeks ]
    Number of exacerbations in four weeks

  12. Cost of healthcare use in euro's [ Time Frame: sixteen weeks ]
    Cost of healthcare use in euro's based on the number of hospitalizations, number and type of contact with physician, use of (professional) homecare, use of medication and absence of (voluntary) work due to illness



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02429050


Locations
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Netherlands
Ciro centre of expertise for chronic organ failure
Horn, Netherlands, 6080 AA
Sponsors and Collaborators
Maastricht University Medical Center
ZonMw: The Netherlands Organisation for Health Research and Development
Investigators
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Principal Investigator: Daisy JA Janssen, MD, PhD Maastricht UMC
Principal Investigator: E. FM Wouters, MD, PhD Maastricht UMC

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Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT02429050     History of Changes
Other Study ID Numbers: 152002
80-83600-98-3006 ( Other Grant/Funding Number: ZonMw )
First Posted: April 29, 2015    Key Record Dates
Last Update Posted: September 4, 2019
Last Verified: March 2019
Keywords provided by Maastricht University Medical Center:
Chronic Obstructive Pulmonary Disease
Dyspnea
Breathlessness
Morphine
Opioid
Symptom Management
Additional relevant MeSH terms:
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Lung Diseases
Pulmonary Disease, Chronic Obstructive
Dyspnea
Respiratory Tract Diseases
Lung Diseases, Obstructive
Respiration Disorders
Signs and Symptoms, Respiratory
Signs and Symptoms
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents