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

NCT ID: NCT00982891

Last Updated: 2013-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2012-06-30

Brief 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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Morphine, low dose, in addition to conventional treatment

Morphine dose titration

Group Type: EXPERIMENTAL

Opioid (morphine sulphate) in low dose

Intervention Type: DRUG

individualized titration

Interventions

Opioid (morphine sulphate) in low dose

individualized titration

Intervention Type: DRUG

Other Intervention Names

M-ESLON (DIN 02019930); morphine sulphate (SR); Doloral 1 (DIN 00614491); morphine hydrochloride; Doloral 5 (DIN 00614505); pms-Hydromorphone (DIN 01916386); hydromorphone hydrochloride; Hydromorph Contin (DIN 02125323) - hydromorphone hydrochloride (SR)

Eligibility 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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

Nova Scotia Health Research Foundation

OTHER_GOV

Sponsor Role: collaborator

Atlantic Health Sciences Corporation

OTHER

Sponsor Role: collaborator

Nova Scotia Health Authority

OTHER

Sponsor Role: lead

Responsible Party

Graeme Rocker

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Graeme M Rocker, DM MHSc

Role: PRINCIPAL_INVESTIGATOR

Dalhousie University/QE II Health Sciences Centre, Halifax, NS

Locations

Horizon Health Network

Saint John, New Brunswick, Canada

Capital District Health Authority

Halifax, Nova Scotia, Canada

Royal University Hospital

Saskatoon, Saskatchewan, Canada

Countries

Canada

References

Rocker GM, Simpson AC; Joanne Young BHSc; Horton R, Sinuff T, Demmons J; Margaret Donahue MDiv MAHSR; Hernandez P, Marciniuk D. Opioid therapy for refractory dyspnea in patients with advanced chronic obstructive pulmonary disease: patients' experiences and outcomes. CMAJ Open. 2013 Jan 24;1(1):E27-36. doi: 10.9778/cmajo.20120031. eCollection 2013 Jan.

Reference Type: DERIVED

PMID: 25077099 (View on PubMed)

Other Identifiers

CIHR IHP 94532

Identifier Type: -

Identifier Source: secondary_id

ROS-003

Identifier Type: -

Identifier Source: org_study_id