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Morphine, Dyspnea, Exercise and COPD

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ClinicalTrials.gov Identifier: NCT01718496
Recruitment Status : Unknown
Verified September 2015 by Jean Bourbeau, McGill University.
Recruitment status was:  Recruiting
First Posted : October 31, 2012
Last Update Posted : September 24, 2015
Sponsor:
Information provided by (Responsible Party):
Jean Bourbeau, McGill University

Tracking Information
First Submitted Date  ICMJE October 15, 2012
First Posted Date  ICMJE October 31, 2012
Last Update Posted Date September 24, 2015
Study Start Date  ICMJE July 2014
Estimated Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 30, 2012)
  • improvement of dyspnea [ Time Frame: one hour ]
  • improvement of exercise tolerance [ Time Frame: one hour ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Morphine, Dyspnea, Exercise and COPD
Official Title  ICMJE Physiological Mechanisms of Dyspnea Relief and Improved Exercise Tolerance After Treatment With Oral Morphine in Patients With Advanced Chronic Obstructive Pulmonary Disease (COPD).
Brief Summary The investigators are studying the effect of a single dose Opioid drug (Morphine) on dyspnea and exercise tolerance in COPD patients.
Detailed Description "Dyspnea" refers to the subjective awareness of breathing discomfort that typically accompanies an increase in physical activity, particularly in patients with Chronic Obstructive Pulmonary Disease (COPD). In these patients, the symptom of dyspnea contributes significantly to exercise intolerance and an impoverished health-related quality of life. Alleviating dyspnea and improving functional capacity are, therefore, among the principal goals of COPD management, i.e., response to therapy. Nevertheless, the effective management of dyspnea and exercise intolerance remains an elusive goal for healthcare providers and current strategies aimed at reversing the patients' underlying chronic disease (e.g., bronchodilators, corticosteroids, supplemental oxygen) are only partially successful in this regard. Evidence-based clinical practice guidelines recommend that, under these circumstances, pain-relieving (opioid) medications may be used for the pharmacologic management of refractory dyspnea and activity-limitation in COPD. Indeed, a handful of published studies provide evidence to suggest that single-dose treatment with morphine or dihydrocodeine improves dyspnea and exercise performance by ~20% in patients with COPD. Nevertheless, little information is available on the physiological mechanisms by which opioid drugs contribute to these improvements in such patients. From a clinical management perspective, this information becomes crucial if we are to optimize the management of exertional symptoms in patients with advanced COPD who remain incapacitated by dyspnea, despite receiving optimal care from their healthcare provider for their underlying disease. Therefore, the purpose of the proposed randomized, double-blind, placebo-controlled, cross-over study is (1) to test the hypothesis that single-dose administration of oral morphine sulphate will improve exertional dyspnea and exercise tolerance in patients with advanced COPD and (2) elucidate the physiological underpinnings of these improvements. To this end, we will compare the effects of single-dose administration of oral morphine sulphate (0.1 mg/kg, equivalent to 7.5 mg for an average 75 kg man) and placebo on dyspnea (sensory intensity and affective responses) and exercise endurance time during symptom-limited constant-work-rate cardiopulmonary cycle exercise testing in symptomatic patients with severe-to-very severe COPD. To explore possible physiological mechanisms of symptom relief, we will measure spirometry parameters, plethysmographic lung volumes and plasma morphine concentrations; perform detailed assessments of central neural respiratory motor drive (i.e., diaphragm electromyography), contractile respiratory muscle function (i.e., esophageal, gastric and transdiaphragmatic pressures), operating lung volumes, ventilation, breathing pattern, pulmonary gas exchange and cardio-metabolic function during exercise; and employ a novel multi-dimensional evaluation technique that permits simultaneous measurement of the sensory intensity and affective dimensions of dyspnea.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Chronic Obstructive Pulmonary Disease
Intervention  ICMJE
  • Drug: Morphine
    patient with advanced COPD will randomly receive single dose Morphine to assess its effect on dyspnea and exercise tolerance
    Other Name: Opioids
  • Drug: Placebo
    patients with advanced COPD on the other study arm will randomly receive Placebo
    Other Name: 0.9% Sodium chloride
Study Arms  ICMJE
  • Active Comparator: Morphine
    Patient with advance COPD who will randomly receive single dose oral Morphine
    Interventions:
    • Drug: Morphine
    • Drug: Placebo
  • Placebo Comparator: Placebo
    patient with advanced COPD who will receive Placebo
    Interventions:
    • Drug: Morphine
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 30, 2012)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2016
Estimated Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01718496
Other Study ID Numbers  ICMJE 2844
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jean Bourbeau, McGill University
Study Sponsor  ICMJE McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dennis Jensen, Ph. D. McGill University
PRS Account McGill University Health Centre/Research Institute of the McGill University Health Centre
Verification Date September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP