Morphine to Maximize the Benefits of Exercise Training in COPD or ILD and Persistent Breathlessness

• Status: Unknown status
• Trial end date: 2020-11-01
• Target enrollment: 0
• Participant gender: All

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 disease (COPD) or interstitial lung disease (ILD) to exercise at higher intensities for longer durations and maximize the psycho-physiological benefits of a supervised exercise training program. We hypothesize that, compared to placebo, exercise training with oral morphine will result in relatively greater improvements in exercise endurance time and intensity ratings of perceived breathlessness during constant-load cardiopulmonary cycle exercise testing (CPET) at 75% of peak power output (PPO).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dennis Jensen, Ph.D.
• Treatments: Morphine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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