Palliation of Dyspnea in Advanced Chronic Obstructive Pulmonary Disease (COPD)

Condition(s) targeted: Chronic Obstructive Pulmonary Disease (COPD)

Intervention: Opioid (morphine sulphate) in low dose (Drug)

Phase: Phase 2/Phase 3

Status: Not yet recruiting

Sponsored by: Capital District Health Authority, Canada

Official(s) and/or principal investigator(s):
Graeme M Rocker, DM MHSc, Principal Investigator, Affiliation: Dalhousie University/QE II Health Sciences Centre, Halifax, NS

Overall contact:
Graeme M Rocker, DM, MHSc, Phone: 902 473 6611, Email: gmrocker@dal.ca

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. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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 following:

- BMI < 21;

- post-bronchodilator FEV1 < 30% predicted;

- one or more hospital admissions for acute exacerbation of COPD in the previous

year.

- 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.

Exclusion Criteria:

- Patients and/or caregivers with cognitive or other difficulties that would preclude

questionnaire completion.

- Inability to speak or understand English.

- Patients considered to be dying or with an expected survival of less than 2 months.

Graeme M Rocker, DM, MHSc, Phone: 902 473 6611, Email: gmrocker@dal.ca

Capital District Health Authority, Halifax, Nova Scotia B3H 3A7, Canada

Starting date: January 2010
Last updated: January 20, 2010