Morphine, Dyspnea, Exercise and COPD
Physiological Mechanisms of Dyspnea Relief and Improved Exercise Tolerance After Treatment With Oral Morphine in Patients With Advanced Chronic Obstructive Pulmonary Disease (COPD).
1 other identifier
interventional
20
1 country
1
Brief Summary
The investigators are studying the effect of a single dose Opioid drug (Morphine) on dyspnea and exercise tolerance in COPD patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 chronic-obstructive-pulmonary-disease
Started Jul 2014
Typical duration for phase_3 chronic-obstructive-pulmonary-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 15, 2012
CompletedFirst Posted
Study publicly available on registry
October 31, 2012
CompletedStudy Start
First participant enrolled
July 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedSeptember 24, 2015
September 1, 2015
2.1 years
October 15, 2012
September 22, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
improvement of dyspnea
one hour
improvement of exercise tolerance
one hour
Study Arms (2)
Morphine
ACTIVE COMPARATORPatient with advance COPD who will randomly receive single dose oral Morphine
Placebo
PLACEBO COMPARATORpatient with advanced COPD who will receive Placebo
Interventions
patient with advanced COPD will randomly receive single dose Morphine to assess its effect on dyspnea and exercise tolerance
patients with advanced COPD on the other study arm will randomly receive Placebo
Eligibility Criteria
You may qualify if:
- sever or very sever COPD, i.e. post B2 agonist FEV1\<50% predicted
- age \>= 40 years
- cigarette smoking history \> 2 pack yrs
- ever chronic activity-related dyspnea defined by the combination of A BDI focal score \<=6, Modified MRC dyspnea scale \>=3 and an OCD rating \<=50
- no change in medication dosage \& frequency in the preceding 6 weeks
- no hospitalization or exacerbation in the preceding 6 weeks
You may not qualify if:
- active cardiopulmonary disease other than COPD
- contraindication to Cardiopulmonary exercise testing
- use of daytime oxygen
- exercise-induced oxyhemoglobin desaturation to \<80% on room air
- Body mass index \<18.5 or \>30 kg/m2
- use of antidepressant drugs in the preceding 2 weeks
- use of opioid drugs in the preceding 4 weeks
- partial pressure of carbon dioxide PCo2 of \>50 mmHg on capillary blood gas
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Montreal Chest Institute
Montreal, Quebec, H2X 2P4, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dennis Jensen, Ph. D.
McGill University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- respirologist
Study Record Dates
First Submitted
October 15, 2012
First Posted
October 31, 2012
Study Start
July 1, 2014
Primary Completion
August 1, 2016
Study Completion
August 1, 2016
Last Updated
September 24, 2015
Record last verified: 2015-09