CClinicalTrials.gg
Status unknownNCT01718496Updated Sep 24, 2015

Morphine, Dyspnea, Exercise and COPD

A Phase 3 interventional study of Morphine and Placebo in Chronic Obstructive Pulmonary Disease, sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre. Status unknown at 1 site in Canada. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2015-09-24.

Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2015), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
40 Years to 80 Years
Sex
All
01

Study summary

The investigators are studying the effect of a single dose Opioid drug (Morphine) on dyspnea and exercise tolerance in COPD patients.

Read the 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.

02

Conditions studied

  • Chronic Obstructive Pulmonary Disease

Keywords

  • dyspnea
  • COPD
  • exercise tolerance
  • opioids
  • morphine
  • single dose oral Morphine
03

In context

Lung Diseases

3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.

This study's planned enrollment of 20 is below the median of 72 across 2,118 interventional studies indexed under Lung Diseases.

Browse Lung Diseases studies →

Lead sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre is the lead sponsor of 414 studies on the registry; 106 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
20 participants (estimated)

Study arms

  • Active comparator
    Morphine

    Patient with advance COPD who will randomly receive single dose oral Morphine

    Drug: Morphine · Drug: Placebo

  • Placebo comparator
    Placebo

    patient with advanced COPD who will receive Placebo

    Drug: Morphine · Drug: Placebo

Interventions

  • DrugMorphine

    patient with advanced COPD will randomly receive single dose Morphine to assess its effect on dyspnea and exercise tolerance

    Also known as: Opioids

  • DrugPlacebo

    patients with advanced COPD on the other study arm will randomly receive Placebo

    Also known as: 0.9% Sodium chloride

06

What researchers measure

Primary outcomes

  1. improvement of dyspnea

    Time frame: one hour

  2. improvement of exercise tolerance

    Time frame: one hour

07

Study locations

1 of 1 sites recruiting
  • Montreal Chest Institute
    Montreal, Quebec H2X 2P4, Canada
    • Dennis Jensen, Ph. D. · Contact · (514) 398-4184
    • Majed Alghamdi, M.D. · Contact · 5149341934
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 24, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01718496
Lead sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Responsible party
Jean Bourbeau (respirologist, McGill University) — Principal investigator
First posted
Oct 31, 2012
Start date
Jul 2014
Primary completion
Aug 2016 (estimated)
Completion
Aug 2016 (estimated)
Last update
Sep 24, 2015

Study contacts

Dennis Jensen, Ph. D.
Contact
dennis.jensen@mcgill.ca
(514) 398-4184 ext. 0572
Majed Alghamdi, M.D.
Contact
majed.rabia@gmail.com
5149341934 ext. 32185
Dennis Jensen, Ph. D.
principal investigator · McGill University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion