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

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

— ROS-003  

Official title:

Palliation of Dyspnea in Advanced Chronic Obstructive Pulmonary Disease: Understanding Patients' and Caregivers' Experiences of Opioid Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00982891
• Other study ID #: ROS-003
• Secondary ID: CIHR IHP 94532
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 21, 2009
• Last updated: January 22, 2013
• Start date: March 2010
• Est. completion date: June 2012

Study information

• Verified date: January 2013
• Source: Nova Scotia Health Authority
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Opioid (morphine sulphate) in low dose
individualized titration

Locations

Country	Name	City	State
Canada	Capital District Health Authority	Halifax	Nova Scotia
Canada	Horizon Health Network	Saint John	New Brunswick
Canada	Royal University Hospital	Saskatoon	Saskatchewan

Sponsors (4)

Lead Sponsor	Collaborator
Nova Scotia Health Authority	Atlantic Health Sciences Corporation, Canadian Institutes of Health Research (CIHR), Nova Scotia Health Research Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To understand the experiences of patients and informal caregivers living with severe COPD, following the addition of opioid therapy to conventional treatment.		6 months	Yes
Secondary	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		6 months	Yes