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

Primary Purpose

Chronic Obstructive Pulmonary Disease (COPD)

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Opioid (morphine sulphate) in low dose
Sponsored by
Nova Scotia Health Authority
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Obstructive Pulmonary Disease (COPD) focused on measuring chronic obstructive pulmonary disease, palliation, opioids

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Horizon Health Network
  • Capital District Health Authority
  • Royal University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Morphine, low dose, in addition to conventional treatment

Arm Description

Morphine dose titration

Outcomes

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.

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

Full Information

First Posted
September 21, 2009
Last Updated
January 22, 2013
Sponsor
Nova Scotia Health Authority
Collaborators
Canadian Institutes of Health Research (CIHR), Nova Scotia Health Research Foundation, Atlantic Health Sciences Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00982891
Brief Title
Palliation of Dyspnea in Advanced Chronic Obstructive Pulmonary Disease (COPD)
Acronym
ROS-003
Official Title
Palliation of Dyspnea in Advanced Chronic Obstructive Pulmonary Disease: Understanding Patients' and Caregivers' Experiences of Opioid Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nova Scotia Health Authority
Collaborators
Canadian Institutes of Health Research (CIHR), Nova Scotia Health Research Foundation, Atlantic Health Sciences Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease (COPD)
Keywords
chronic obstructive pulmonary disease, palliation, opioids

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Morphine, low dose, in addition to conventional treatment
Arm Type
Experimental
Arm Description
Morphine dose titration
Intervention Type
Drug
Intervention Name(s)
Opioid (morphine sulphate) in low dose
Other Intervention Name(s)
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)
Intervention Description
individualized titration
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Graeme M Rocker, DM MHSc
Organizational Affiliation
Dalhousie University/QE II Health Sciences Centre, Halifax, NS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Horizon Health Network
City
Saint John
State/Province
New Brunswick
ZIP/Postal Code
E2L 4L2
Country
Canada
Facility Name
Capital District Health Authority
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 3A7
Country
Canada
Facility Name
Royal University Hospital
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 0W8
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
25077099
Citation
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.
Results Reference
derived

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

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