Palliation of Dyspnea in Advanced Chronic Obstructive Pulmonary Disease (COPD) (ROS-003)

January 22, 2013 updated by: Graeme Rocker, Nova Scotia Health Authority

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • New Brunswick
      • Saint John, New Brunswick, Canada, E2L 4L2
        • Horizon Health Network
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 3A7
        • Capital District Health Authority
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N 0W8
        • Royal University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Morphine, low dose, in addition to conventional treatment
Morphine dose titration
Drug: Opioid (morphine sulphate) in low dose
individualized titration
Other Names:
  • 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)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nova Scotia Health Authority

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Canadian Institutes of Health Research (CIHR)
Nova Scotia Health Research Foundation
Atlantic Health Sciences Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Graeme M Rocker, DM MHSc, Dalhousie University/QE II Health Sciences Centre, Halifax, NS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 21, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 22, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 23, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 23, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ROS-003
  • CIHR IHP 94532

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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