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Trial NCT00982891

Resource URI: http://static.linkedct.org/resource/trials/NCT00982891
linkedct:acronym ROS-003
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/53461>
linkedct:brief_title Palliation of Dyspnea in Advanced Chronic Obstructive Pulmonary Disease (COPD)
linkedct:collaborator_agency <http://static.linkedct.org/resource/collabagency/1060>
linkedct:collaborator_agency <http://static.linkedct.org/resource/collabagency/545>
linkedct:collaborator_agency <http://static.linkedct.org/resource/collabagency/5858>
linkedct:condition <http://static.linkedct.org/resource/condition/2818>
linkedct: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.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age N/A
linkedct:eligibility_minimum_age N/A
linkedct:end_date September 2011
linkedct:enrollment 45 (xsd:int)
linkedct:firstreceived_date September 21, 2009
linkedct:has_dmc No
linkedct:id NCT00982891
linkedct:intervention <http://static.linkedct.org/resource/intervention/100667>
rdfs:label Trial NCT00982891
linkedct:lastchanged_date September 22, 2009
linkedct:lead_sponsor_agency Capital District Health Authority, Canada
linkedct:location <http://static.linkedct.org/resource/location/16562>
linkedct:nct_id NCT00982891
linkedct:number_of_arms 1 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title Palliation of Dyspnea in Advanced Chronic Obstructive Pulmonary Disease: Understanding Patients' and Caregivers' Experiences of Opioid Therapy
linkedct:org_study_id ROS-003
linkedct:overall_contact_email gmrocker@dal.ca
linkedct:overall_contact_last_name Graeme M Rocker, DM, MHSc
linkedct:overall_contact_phone 902 473 6611
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/20578>
linkedct:overall_status Not yet recruiting
linkedct:oversight <http://static.linkedct.org/resource/oversight/415>
foaf:page <http://clinicaltrials.gov/show/NCT00982891>
linkedct:phase Phase 2/Phase 3
linkedct:primary_completion_date September 2011
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/47993>
linkedct:secondary_id CIHR IHP 94532
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/126327>
linkedct:source Capital District Health Authority, Canada
linkedct:start_date September 2009
linkedct:study_design Supportive Care, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
linkedct:study_type Interventional
linkedct: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.
rdf:type linkedct:trials
linkedct:verification_date September 2009