Palliation of Dyspnea in Advanced Chronic Obstructive Pulmonary Disease (COPD) (ROS-003)

This study has been completed.
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Nova Scotia Health Research Foundation
Atlantic Health Sciences Corporation
Information provided by (Responsible Party):
Graeme Rocker, Capital District Health Authority, Canada
ClinicalTrials.gov Identifier:
NCT00982891
First received: September 21, 2009
Last updated: January 22, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease (COPD)
Drug: Opioid (morphine sulphate) in low dose
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Palliation of Dyspnea in Advanced Chronic Obstructive Pulmonary Disease: Understanding Patients' and Caregivers' Experiences of Opioid Therapy

Resource links provided by NLM:


Further study details as provided by Capital District Health Authority, Canada:

Primary Outcome Measures:
  • To understand the experiences of patients and informal caregivers living with severe COPD, following the addition of opioid therapy to conventional treatment. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 45
Study Start Date: March 2010
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Morphine, low dose, in addition to conventional treatment
Morphine dose titration
Drug: Opioid (morphine sulphate) in low dose
individualized titration
Other 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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00982891

Locations
Canada, New Brunswick
Horizon Health Network
Saint John, New Brunswick, Canada, E2L 4L2
Canada, Nova Scotia
Capital District Health Authority
Halifax, Nova Scotia, Canada, B3H 3A7
Canada, Saskatchewan
Royal University Hospital
Saskatoon, Saskatchewan, Canada, S7N 0W8
Sponsors and Collaborators
Capital District Health Authority, Canada
Canadian Institutes of Health Research (CIHR)
Nova Scotia Health Research Foundation
Atlantic Health Sciences Corporation
Investigators
Principal Investigator: Graeme M Rocker, DM MHSc Dalhousie University/QE II Health Sciences Centre, Halifax, NS
  More Information

No publications provided

Responsible Party: Graeme Rocker, Professor of Medicine, Capital District Health Authority, Canada
ClinicalTrials.gov Identifier: NCT00982891     History of Changes
Other Study ID Numbers: ROS-003, CIHR IHP 94532
Study First Received: September 21, 2009
Last Updated: January 22, 2013
Health Authority: Canada: Health Canada

Keywords provided by Capital District Health Authority, Canada:
chronic obstructive pulmonary disease
palliation
opioids

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Hydromorphone
Morphine
Analgesics
Analgesics, Opioid
Central Nervous System Agents
Central Nervous System Depressants
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014