- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00982891
Palliation of Dyspnea in Advanced Chronic Obstructive Pulmonary Disease (COPD) (ROS-003)
January 22, 2013 updated by: Graeme Rocker, Nova Scotia Health Authority
Palliation of Dyspnea in Advanced Chronic Obstructive Pulmonary Disease: Understanding Patients' and Caregivers' Experiences of Opioid Therapy
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
45
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New Brunswick
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Saint John, New Brunswick, Canada, E2L 4L2
- Horizon Health Network
-
-
Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 3A7
- Capital District Health Authority
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-
Saskatchewan
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Saskatoon, Saskatchewan, Canada, S7N 0W8
- Royal University Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Morphine, low dose, in addition to conventional treatment
Morphine dose titration
|
individualized titration
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Graeme M Rocker, DM MHSc, Dalhousie University/QE II Health Sciences Centre, Halifax, NS
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2010
Primary Completion (Actual)
June 1, 2012
Study Completion (Actual)
June 1, 2012
Study Registration Dates
First Submitted
September 21, 2009
First Submitted That Met QC Criteria
September 22, 2009
First Posted (Estimate)
September 23, 2009
Study Record Updates
Last Update Posted (Estimate)
January 23, 2013
Last Update Submitted That Met QC Criteria
January 22, 2013
Last Verified
January 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Respiration Disorders
- Signs and Symptoms, Respiratory
- Lung Diseases
- Lung Diseases, Obstructive
- Pulmonary Disease, Chronic Obstructive
- Dyspnea
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Opioid
- Narcotics
- Morphine
- Hydromorphone
Other Study ID Numbers
- ROS-003
- CIHR IHP 94532
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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