Status:
COMPLETED
Palliation of Dyspnea in Advanced Chronic Obstructive Pulmonary Disease (COPD)
Lead Sponsor:
Nova Scotia Health Authority
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Nova Scotia Health Research Foundation
Conditions:
Chronic Obstructive Pulmonary Disease (COPD)
Eligibility:
All Genders
Phase:
PHASE2
PHASE3
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 (d...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00982891
Start Date
March 1 2010
End Date
June 1 2012
Last Update
January 23 2013
Active Locations (3)
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1
Horizon Health Network
Saint John, New Brunswick, Canada, E2L 4L2
2
Capital District Health Authority
Halifax, Nova Scotia, Canada, B3H 3A7
3
Royal University Hospital
Saskatoon, Saskatchewan, Canada, S7N 0W8