Recruiting
Phase 3

Morphine

Sponsor:

McGill University Health Centre/Research Institute of the McGill University Health Centre

Code:

NCT01718496

Conditions

Chronic Obstructive Pulmonary Disease

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

Morphine

Placebo

Study Details

Brief summary:

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

Conditions

Chronic Obstructive Pulmonary Disease

Study ID

NCT01718496

Start date

Jul, 2014

Status verified date

Sep, 2015

Completion date

Aug, 2016

Anticipated

Primary completion date

Aug, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Morphine

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

placebo comparator: Placebo

patient with advanced COPD who will receive Placebo

Interventions

Morphine

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

Placebo

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

Primary outcome measure

  • improvement of dyspnea [ Time Frame: one hour ]
  • improvement of exercise tolerance [ Time Frame: one hour ]

Central Contacts and Locations

Central contacts

Dennis Jensen, Ph. D.

(514) 398-4184dennis.jensen@mcgill.ca

Majed Alghamdi, M.D.

5149341934majed.rabia@gmail.com

Locations

Montreal Chest Institute

Recruiting

Montreal, Quebec, Canada, H2X 2P4

Contacts

Dennis Jensen, Ph. D.

(514) 398-4184

Majed Alghamdi, M.D.

5149341934

More Information

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Last update posted

Sep 24, 2015

Last verified

Sep, 2015

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McGill University Health Centre/Research Institute of the McGill University Health Centre on 2015-09-24.