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

NCT00982891 | Completed Phase 2

• 2 other identifiers: ROS-003CIHR IHP 94532
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 3

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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

chronic obstructive pulmonary disease; palliation; opioids

Outcome Measures

Primary Outcomes (1)

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

  6 months

Secondary Outcomes (1)

• 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

  6 months

Study Arms (1)

Morphine, low dose, in addition to conventional treatment

EXPERIMENTAL

Morphine dose titration

Drug: Opioid (morphine sulphate) in low dose

Interventions

Opioid (morphine sulphate) in low dose DRUG

individualized titration

Also known as: 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)

Morphine, low dose, in addition to conventional treatment

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nova Scotia Health Authority: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Nova Scotia Health Research Foundation: collaborator
• Atlantic Health Sciences Corporation: collaborator

Study Sites (3)

Horizon Health Network

Saint John, New Brunswick, E2L 4L2, Canada

Location

Capital District Health Authority

Halifax, Nova Scotia, B3H 3A7, Canada

Location

Royal University Hospital

Saskatoon, Saskatchewan, S7N 0W8, Canada

Location

Related Publications (1)

• 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.

  PMID: 25077099 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Analgesics, Opioid; Morphine; Hydromorphone

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Graeme M Rocker, DM MHSc

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: September 21, 2009
• First Posted: September 23, 2009
• Study Start: March 1, 2010
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: January 23, 2013

Record last verified: 2013-01

Locations

CA (3)