Palliation of Dyspnea in Advanced Chronic Obstructive Pulmonary Disease (COPD) (ROS-003)
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|ClinicalTrials.gov Identifier: NCT00982891|
Recruitment Status : Completed
First Posted : September 23, 2009
Last Update Posted : January 23, 2013
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|Condition or disease||Intervention/treatment||Phase|
|Chronic Obstructive Pulmonary Disease (COPD)||Drug: Opioid (morphine sulphate) in low dose||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||45 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Palliation of Dyspnea in Advanced Chronic Obstructive Pulmonary Disease: Understanding Patients' and Caregivers' Experiences of Opioid Therapy|
|Study Start Date :||March 2010|
|Actual Primary Completion Date :||June 2012|
|Actual Study Completion Date :||June 2012|
Experimental: Morphine, low dose, in addition to conventional treatment
Morphine dose titration
Drug: Opioid (morphine sulphate) in low dose
- 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 ]
- 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 ]
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|Ages Eligible for Study:||Child, Adult, Older Adult|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00982891
|Canada, New Brunswick|
|Horizon Health Network|
|Saint John, New Brunswick, Canada, E2L 4L2|
|Canada, Nova Scotia|
|Capital District Health Authority|
|Halifax, Nova Scotia, Canada, B3H 3A7|
|Royal University Hospital|
|Saskatoon, Saskatchewan, Canada, S7N 0W8|
|Principal Investigator:||Graeme M Rocker, DM MHSc||Dalhousie University/QE II Health Sciences Centre, Halifax, NS|
|Responsible Party:||Graeme Rocker, Professor of Medicine, Nova Scotia Health Authority|
|Other Study ID Numbers:||
CIHR IHP 94532
|First Posted:||September 23, 2009 Key Record Dates|
|Last Update Posted:||January 23, 2013|
|Last Verified:||January 2013|
chronic obstructive pulmonary disease
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents