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)

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12618001805268

Acronym

The EMphysema, PHYSiology, and exercISe responsE Trial (EMPHYSISE)

Enrollment

Registered

2018-11-06

Start date

2019-02-27

Completion date

2020-12-31

Last updated

2019-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

Interventions

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

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

- Established diagnosis of COPD with hyperinflation: post-bronchodilator FEV1 <50% of predicted AND TLC > 100% AND RV>175% - The absence of any collateral ventilation between target lobe and ipsilateral lobe, diagnosed with quantitative CT fissure integrity of >90% and confirmation of integrity with Chartis measurement. - Age >18 and <75 at the time of enrolment. - 6-min walk test distance >150m following successful completion of a pulmonary rehabilitation program (or equivalent program). - No evidence of significant coexistent pulmonary pathology on HRCT - Able to safely undergo sedation or general anesthesia and bronchoscopy - Cessation of smoking for 3 months prior

Exclusion criteria

Any patient deemed not suitable for EBV insertion based on internationally accepted best-practice guidelines. Considerations include: - Significant co-existent pulmonary pathology - Severe Hypercapnia (pCO2 > 60mmHg on room air) - Unstable cardiovascular disease - Severe heart failure: EF <35% - Unstable cardiac arrhythmia, myocardial infarction or stroke within 6 months - Severe PAH: RVSP >45mmHg - Current Smoker - 6MWT distance less than 150m post pulmonary rehabilitation or equivalent program - FEV1 <15% predicted - Any device or foreign object deemed unsafe for MRI (e.g. Pacemaker, shrapnel etc.) - Pregnancy or potentially pregnant - Egg or protein allergies

Outcome results