RecruitingPhase 3ACTRN12611001182987

Does blocking the body's own morphine-like chemicals during exercise change the perception of breathlessness?

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.

Sponsor

Flinders University- Deptment of Palliative and Supportive Services

Enrollment

30 participants

Start Date

Nov 11, 2011

Study Type

Interventional

Conditions

Breathlessness during exercise in people with Chronic Obstructive Pulmonary Disease.

Summary

The aim of the study is to understand the role of endogenous opioids ( the body's own morphine-like chemicals) in regulating breathlessness in people with Chronic Obstructive Airways Disease and to answer the question "Does blocking these endogenous opioids during exercise change the perseption of breathlessness. Trial details Participants with moderate to severe Chronic Obstructive Pulmonary Airways (COPD) disease, if eligible will be asked to attend the clinic up to 5 times over the study period and each visit will take about 2 hours. After a baseline exercise test on a treadmill participants will have 4 subsequent standardised treadmill exercise sessions.Each test will comprise of up to 15 minutes on the treadmill with the aim of walking as far as possilbe at a steady pace. Visits will be weeklyand a doctor and nurse will be present at all times during the proceedure. Bloods will be taken on visit 3 to measure two chemicals that the body routinely makes- beta endorphin and adrenocorticotrophin. 30 minutes before each exercise test the participant will be administered 5mg of salbutamol through an inhaler. On the 3th,4th and 5th exercise test participants will receive a double blind injection on different visits of each of saline, methylnaltrexone and naloxone, in a random ( by chance) order. During the 15 minute exercise tests, participants will be asked to record the intensity and unpleasantness of their breathlessness and how tired their legs feel, every minute by means of a touch pad screen. Throughout each test and for 30 minutes after stopping the participant will be attached to cardiac monitor and their blood pressure will be monitored regularly.

Eligibility

Sex: Both males and femalesMin Age: 51 Yearss

Plain Language Summary

Simplified for easier understanding

This study looks at whether the body's natural pain-relieving chemicals (called endorphins or endogenous opioids) play a role in controlling breathlessness in people with moderate to severe chronic obstructive pulmonary disease (COPD). Researchers will block these chemicals using injections given before exercise sessions on a treadmill, to see if it changes how breathless you feel. You will attend up to 5 visits, each about 2 hours long, with a doctor and nurse always present. You may be eligible if: - You are over 50 years old - You have moderate to severe COPD confirmed by breathing tests - You have a significant history of smoking (at least 10 pack-years) - You feel quite breathless during daily activities (MRC breathlessness score 3 or 4) - You are on stable medications for at least one week - You are able to walk on a treadmill You may NOT be eligible if: - You use opioid pain medications regularly - You have had a heart attack, severe angina, or were hospitalised for heart failure in the last year - You have serious heart rhythm problems or high blood pressure above 160/110 mmHg - You have cystic fibrosis, bronchiectasis, or active tuberculosis - You have a BMI over 35 - You have completed pulmonary rehabilitation in the past 6 weeks - You have cognitive impairment (Mini Mental State score below 24) Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

The main object of the study is to compare the effects of i.v. administration of naloxone, methylnaltrexone and normal saline on ratings of dyspnoea during contant work rate treadmil exercise. 30 minutes prior to each test the participant will be administered 5mg of salbutamol in 2.5 of normal saline via a nebuliser. At visit 1( baseline) this test is for maximal incremental cardiopulmonary exercise test (iCPET) according to the modified Balke protocol. This iCPET may take up to 25 minutes depending on the participant's endurance but will be ceased when the individual’s perception of dyspnoea or leg fatigue prevents them from maintaining the required minimum speed. At the subsequent 4 weekly visits a constant rate cardio pulmonary exercise test (cCPET) of optimal training intensity, 75%WRmax will be undertaken to exhaustion with the aim that this will be at least 10 minutes of effort. Throughout each exercise test and for 30 minutes after stopping, the participant will be attached to a 12 lead cardiac safety monitor and their blood pressure will be recorded regularly. Ventilatory and metabolic measurements of exercise will be recorded using a portable gas exchange monitor (COSMED model) through which patients will breathe allowing physiologic and metabolic parameters to be recorded in real time. A medical officer, 2-3 nurses and respiratory technician will be present throughout each visit and the tests will be performed in the cardiology department . Arm 1 - once only dose of naloxone, 0.1mg/kg (10mg maximum) diluted to a standard volume, given intravenously 15 minutes a constant rate cardio pulmonary exercise test (cCPET) of optimal training intensity, 75%WRmax will be undertaken to exhaustion with the aim that this will be at least 10 minutes of effort. Arm 2 -once only dose methylnaltrexone,0.3mg/kg (30mg maximum) diluted to a standard volume, given intravenously 15 minutes prior to a constant rate cardio pulmonary exercise test (cCPET) of optimal training intensity, 75%WRmax will be undertaken to exhaustion with the aim that this will be at least 10 minutes of effort. There will be a 7 days wash out period between each arm and the placebo.

Locations(1)

Australia

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ACTRN12611001182987