RecruitingACTRN12618001805268

Investigating the changes in physiological function following bronchoscopic lung volume reduction treatment of chronic obstructive pulmonary disease (COPD)

The Physiological Changes Following Bronchoscopic Lung Volume Reduction Treatment for Chronic Obstructive Pulmonary Disease (COPD)


Sponsor

University of Adelaide

Enrollment

50 participants

Start Date

Feb 27, 2019

Study Type

Observational

Conditions

Summary

This clinical trial aims to determine why the positive findings in lung function and exercise tolerance occur following bronchoscopic lung volume reduction therapy of Chronic Obstructive Pulmonary Disease (COPD). It is thought that these improvements are a result of changes in lung, heart, and vasculature physiology following this treatment. This trial will investigate all three areas, using a combination of Cardiopulmonary Exercise Testing (CPET), Echocardiogram, Cardiac Magentic Resonance Imaging, Nuclear Medicine SPECT scanning, and measurement of blood serum biomarkers. The results of this study may assist in the future identification and selection of patients for this procedure, thereby improving their overall care and management.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 75 Yearss

Plain Language Summary

Simplified for easier understanding

Chronic obstructive pulmonary disease (COPD) is a serious lung condition that makes it progressively harder to breathe. For some people with severe COPD, a procedure called bronchoscopic lung volume reduction can help — this involves placing tiny valves inside the airways using a bronchoscope (a thin tube passed down the throat) to deflate the most damaged parts of the lung, allowing the healthier parts to work better. Patients who have this procedure often show improvements in breathing capacity and exercise tolerance, but researchers are not yet sure exactly why. This study will closely examine the changes in lung, heart, and blood vessel function that occur after the procedure, using a combination of exercise testing, echocardiogram (heart ultrasound), cardiac MRI, specialised lung scans, and blood tests. Understanding the mechanisms behind the benefit may help identify which patients are most likely to respond well. You may be eligible if you are aged 18–75, have a confirmed diagnosis of severe COPD with air trapping, have completed pulmonary rehabilitation, have stopped smoking for at least 3 months, and have been assessed as suitable for the valve procedure. People with certain co-existing lung conditions, severe heart disease, or an implanted device not compatible with MRI are not eligible.

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Interventions

Examining the physiological changes following bronchoscopic lung volume reduction using endobronchial valves using the following investigations: - Cardiopulmonary Exercise Test: VO2 max test (60mins

Examining the physiological changes following bronchoscopic lung volume reduction using endobronchial valves using the following investigations: - Cardiopulmonary Exercise Test: VO2 max test (60mins including setup time) - Cardiopulmonary Exercise Test: Constant Workrate (60mins including setup time) - Cardiac Echocardiogram (30mins) - Cardiac MRI (30-45mins) - V/Q SPECT scanning (60 mins) - Blood Serum Sampling of humoral and inflammatory biomarkers (5mins done on day of BLVR procedure at time of admission and at 3-month review post BLVR) Investigations will occur at least 2 weeks prior to BLVR and then be repeated again 3 months after the BLVR procedure. Who will be performing/administering assessments?: CPETs - Respiratory physiology scientist with a supervising doctor overseeing testing Cardiac Echocardiogram - Reference Cardiologist (co-investigator) Cardiac MRI - Reference Radiographer, radiologist, and cardiologist (co-investigator) V/Q SPECT - Reference Radiographer and nuclear physician (co-investigator) Blood Serum sampling - Primary investigator


Locations(5)

The Royal Adelaide Hospital - Adelaide

NSW,QLD,SA, Australia

The Queen Elizabeth Hospital - Woodville

NSW,QLD,SA, Australia

Liverpool Hospital - Liverpool

NSW,QLD,SA, Australia

Macquarie University Hospital - Macquarie Park

NSW,QLD,SA, Australia

Royal Brisbane & Womens Hospital - Herston

NSW,QLD,SA, Australia

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ACTRN12618001805268


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