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


Phase 2/Phase 3
N/A
N/A
Not Enrolling
Both
Chronic Obstructive Pulmonary Disease (COPD)

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To understand the experiences of patients and informal caregivers living with severe COPD, following the addition of opioid therapy to conventional treatment.

Outcome Time Frame:

6 months

Safety Issue:

Yes

Principal Investigator

Graeme M Rocker, DM MHSc

Investigator Role:

Principal Investigator

Investigator Affiliation:

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

Authority:

Canada: Health Canada

Study ID:

ROS-003

NCT ID:

NCT00982891

Start Date:

March 2010

Completion Date:

June 2012

Related Keywords:

  • Chronic Obstructive Pulmonary Disease (COPD)
  • chronic obstructive pulmonary disease
  • palliation
  • opioids
  • Lung Diseases
  • Respiration Disorders
  • Pulmonary Disease, Chronic Obstructive
  • Lung Diseases, Obstructive

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