The role of peripheral opioid receptors in modulating breathlessness. An in vivo placebo controlled, triple arm, cross over , double blind study of naloxone and methylnaltrexone on breathlessness during exercise in people with Chronic Obstructive Airway Disease.

Flinders University- Deptment of Palliative and Supportive Services0 sites30 target enrollmentNovember 15, 2011

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Not specified
Sponsor: Flinders University- Deptment of Palliative and Supportive Services
Enrollment: 30
Status: Recruiting
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

November 15, 2011

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Flinders University- Deptment of Palliative and Supportive Services

Eligibility Criteria

Inclusion Criteria

•On stable medications for breathlessness over the prior one week except routine as needed” medications. Able to provide written and dated informed consent.Moderate / severe COPD. (FEV1 30%\-80% of predicted for age in spirometry performed approximately 10\-15 minutes after the subject has self\-administered 4 inhalations (i.e., total 400mcg) of albuterol/salbutamol via a metered dose inhaler (MDI) with a valved\-holding chamber. The FEV1/FVC ratio and FEV1 percent predicted values will be calculated using NHANES III reference equations) \[Hankinson 1999]. Subjects will have COPD which complies with the definition of the American Thoracic. Society/European Respiratory Society. \[Celli, 2004\). Modified Medical Research Council breathlessness scale of 3 or 4\. \>50 years of age. \>10 pack year history of smoking (number of pack years \= (number of cigarettes per day/20\) x number of years smoked). Able to use a treadmill.

Exclusion Criteria

•On regular or ‘as needed’ opioids in the week before commencing the study and at any time during the study.
•Unable to give informed consent or complete evaluation tool entries. Cognitively impaired (Mini Mental State \< 24\). \[Folstein]. Calculated creatinine clearance of \< 30mls using MDRD. \[Levey 1999] . Known or suspected bowel obstruction (specific contra\-indications in methylnaltrexone) or known or suspected GI lesions.
•Participants with any of the following clinical conditions:
•a history of myocardial infarction, unstable angina or untreated severe left anterior descending coronary artery compromise within 1 year of screening visit, cardiac arrhythmia causing symptoms or haemodynamic compromise, atrioventricular block, hospitalized for heart failure within the past year, claudication, known active tuberculosis or other chronic lung infection, a history of life\-threatening pulmonary obstruction, a history of cystic fibrosis, clinically evident bronchiectasis.
•Contraindications for exercise testing which would include
•active endocarditis, myocarditis or pericarditis, hypertrophic cardiomyopathy, symptomatic moderate to severe aortic stenosis, severe untreated arterial hypertension (\>160 mmHg systolic, \>110 mmHg diastolic), significant pulmonary hypertension, untreated venous thromboembolism, active systemic infection, uncontrolled hyperthyroidism, body mass index (BMI) \>35, physical limitations due to arthritis, joint replacement, people on monoamine oxidase inhibitors. Participants who are currently under going pulmonary rehabilitation or have completed a pulmonary rehabilitation program in the previous six weeks. Participants with an endurance time \> 25 minutes during the training (visit 2\)