Palliation of Dyspnea in Advanced Chronic Obstructive Pulmonary Disease (COPD)
Information source: Nova Scotia Health Authority
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Obstructive Pulmonary Disease (COPD)
Intervention: Opioid (morphine sulphate) in low dose (Drug)
Phase: Phase 2/Phase 3
Sponsored by: Nova Scotia Health Authority
Official(s) and/or principal investigator(s):
Graeme M Rocker, DM MHSc, Principal Investigator, Affiliation: Dalhousie University/QE II Health Sciences Centre, Halifax, NS
Chronic Obstructive Pulmonary Disease (COPD) affects at least 750,000 Canadians and is
currently the 4th leading cause of death in Canada. Almost everyone with COPD suffers from
shortness of breath (dyspnea) that worsens over time despite standard treatment (inhalers,
exercise programs and oxygen). Patients and families have identified relief from dyspnea as
a top priority for improved care. New approaches are needed for treating advanced COPD to
lessen the burden that it places on the lives of patients and families alike. Opioid drugs,
such as morphine, can help in COPD in many ways, including reducing dyspnea, fear and
anxiety. Opioids are used widely in cancer for similar symptoms. However, there are
historical biases against their use in advanced COPD (mostly due to fear of side effects
when much higher doses than the investigators intend have been used in the past). No studies
have assessed the value to patients of using low dose opioids in advanced COPD in addition
to conventional treatment. The investigators are planning a study that involves recording
interviews with about 30 patients and their partner or key family member before and after
starting treatment with low dose morphine, to understand their experiences with using
morphine. The investigators will also ask them to complete questionnaires about quality of
life, dyspnea, anxiety, depression and fear. Descriptions of experiences of using morphine
have the potential to inform patients, families, clinicians and professional societies about
the benefits and harms of opioid use for dyspnea in the advanced stages of a common serious
lung disease when traditional treatments often fail. The investigators will conduct the
study in both urban (Halifax and Saskatoon) and in a rural setting (New Brunswick). The
investigators' study of an inexpensive and widely available treatment has the potential to
improve care and outcomes in advanced COPD for the many Canadians living and dying with this
serious lung disease.
Official title: Palliation of Dyspnea in Advanced Chronic Obstructive Pulmonary Disease: Understanding Patients' and Caregivers' Experiences of Opioid Therapy
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Primary outcome: To understand the experiences of patients and informal caregivers living with severe COPD, following the addition of opioid therapy to conventional treatment.
Secondary outcome: To explore the effect of opioid therapy on dyspnea and on quality of life, anxiety, depression, caregiver experiences and to determine proportion of patients finding opioids helpful at 4-6 months
Minimum age: N/A.
Maximum age: N/A.
- We define advanced COPD as including those with severe COPD by CTS criteria (i. e.,
severe shortness of breath resulting in the patient being too breathless to leave the
house, or breathlessness after dressing/undressing (i. e., Medical Research Council
(MRC) score of 5), or the presence of chronic respiratory failure (PaCO2>45) or
clinical signs of right heart failure).
- We will also include patients who are short of breath and stop walking after about
100 meters or a few minutes on the level (MRC score 4) with at least one the
- BMI < 21;
- post-bronchodilator FEV1 < 30% predicted;
- one or more hospital admissions for acute exacerbation of COPD in the previous
- MRC 4 patients will be recruited only if their baseline Chronic Respiratory
Questionnaire - dyspnea domain (CRQ-D) score is < 5, an entry criterion used in a
Canadian RCT involving patients with advanced lung disease.
- Patients and/or caregivers with cognitive or other difficulties that would preclude
- Inability to speak or understand English.
- Patients considered to be dying or with an expected survival of less than 2 months.
Locations and Contacts
Horizon Health Network, Saint John, New Brunswick E2L 4L2, Canada
Capital District Health Authority, Halifax, Nova Scotia B3H 3A7, Canada
Royal University Hospital, Saskatoon, Saskatchewan S7N 0W8, Canada
Starting date: March 2010
Last updated: January 22, 2013