Status:
UNKNOWN
Morphine to Maximize the Benefits of Exercise Training in COPD or ILD and Persistent Breathlessness
Lead Sponsor:
Dennis Jensen, Ph.D.
Conditions:
Chronic Obstructive Pulmonary Disease
Interstitial Lung Disease
Eligibility:
All Genders
35+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to explore the role of low-dose immediate-release oral morphine as a novel adjunct pharmacotherapy to enable symptomatic adults with advanced chronic obstructive pulmonary...
Detailed Description
Supervised exercise training programs (such as pulmonary rehabilitation) are an integral component of the clinical management of COPD or ILD; a proven intervention for improving symptom burden, qualit...
Eligibility Criteria
Inclusion
- Males and females aged 35 years and over
- Clinical diagnosis of COPD or ILD
- Cigarette smoking history ≥20 years (COPD only)
- Post bronchodilator FEV1 \<50% predicted and FEV1/FVC \<0.70 (COPD only)
- Chronic breathlessness syndrome (modified Medical Research Council dyspnea score ≥3; Baseline Dyspnea Index focal score ≤6; and/or an Oxygen Cost Diagram rating ≤50% full scale despite optimal treatment of the underlying pathophysiology according to evidence-based clinical practice guidelines
- Report breathlessness as the main limiting factor to incremental CPET
- Body mass index \>18.5 kg/m2 and \<35 kg/m2
Exclusion
- Changed respiratory medication dosage and/or frequency of administration in preceding two weeks
- Disease exacerbation/hospitalization in preceding six weeks
- Arterialized capillary CO2 tension (PacCO2) \>50 mmHg at rest
- Self-reported history of drug addiction and/or substance abuse assessed with the CAIG-aid and SISAP questionnaires
- Severe excessive daytime sleepiness assessed with the Epworth Sleepiness Scale (score of 16 out of 24)
- Currently use anti-seizure and/or opioid drug(s)
- Use daytime supplemental oxygen
- Exercise-induced oxyhemoglobin desaturation to \<80% on room air
- Participated in a pulmonary rehabilitation program in preceding 6 months
- Allergy/sensitivity to opioid drugs
- Significant extra-pulmonary disease that could impair exercise tolerance
- Contraindication(s) to cardiopulmonary exercise testing (e.g., significant cardiovascular, musculoskeletal, neurological disease)
- Pregnant or currently trying to become pregnant: women of child bearing potential (defined as having a menstrual period within the last 12 months) will be required to take a routine (urine) pregnancy test to rule out the possibility of pregnancy
- Self-report any of the following conditions: anemia or abnormally low blood volume; asthma; hypothyroidism; Addison's disease; renal insufficiency; hypopituitarism; severe malnutrition; digestive disease (any form of colitis disease); prostatic hypertrophy or urethral stricture
- Use of the blood thinning (anti-coagulant) drug Coumadin, Pradaxa, Xarelto and Eliquis in previous 2 weeks
Key Trial Info
Start Date :
August 6 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2020
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03824834
Start Date
August 6 2019
End Date
November 1 2020
Last Update
August 16 2019
Active Locations (1)
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1
Montreal Chest Institute of the McGill University Health Center (MUHC)
Montreal, Quebec, Canada, H4A 3J1