About this trial
Emphysema is a progressive phenotype of chronic Obstructive Pulmonary Disease (COPD), poses a significant global health burden characterized by irreversible lung parenchymal destruction and airspace enlargement.
In recent years, bronchoscopic lung volume reduction (BLVR) has considerable interest as a minimally invasive approach to reducing hyperinflation and improving lung function in patients with emphysema.
BLVR techniques aim to achieve lung volume reduction by occluding or ablating emphysematous lung tissue through endobronchial delivery of various agents. Many techniques are available for BLVR as coil, endo-bronchial valve, and biological as thrombin, autologous blood and chemicals as silver nitrate solution.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
COPD of grade III and IV according to GOLD 2024 staging of COPD with localized (heterogeneous) emphysema as determined by high resolution computerized tomography (HRCT) of the chest with area of destruction >-950 Hounsfield units (HU) and respiratory symptoms despite optimal medical therapy with the following criteria: Patient less than 75 years of age not candidate for or had refused lung volume reduction surgery but fit for fibro-optic bronchoscope (FOB). Lung volumes criteria: FEV1 less than 60% of predicted value, Residual volume (RV) more than 100% of predicted value, Total lung capacity (TLC) more than 100% of predicted value, 6 MWT of less than 450 meters.
Disqualifiers
Significant co-morbidities that limits exercise capacity or prognosis as cardiovascular diseases (heart failure, arrhythmia, ischemic heart disease) and lung cancer.
Patients unfit or refused FOB.
Homogenous emphysema.
More than 75 years of age.
Trial design
Parallel
Treatments tested in this trial
Silver Nitrate
Drugbronchoscopic lung volume reduction in management of localized emphysema
Nano-silver nitrate
Drugbronchoscopic lung volume reduction in management of localized emphysema
Bronchoscopic lung volume reduction
Devicebronchoscopic lung volume reduction in management of localized emphysema
Treatment groups
Trial outcomes
Primary outcomes
Residual volume/ Total lung capacity (RV/TLC) ratio and volumetry
RV/TLC ratio measured at 6 months following treatment. Treatment success is defined as a statistically significant reduction in RV/TLC and from baseline.
change in Forced expiratory volume at first second (FEV1) and Forced vital capacity (FVC)
change from baseline to 6 months in FEV1 and FVC,
Voluometry
Voluometry measured at 6 months following treatment. Treatment success is defined as a statistically significant reduction in voluometry and from baseline.
diffusing capacity of the lung for carbon monoxide (DLCO)
change from baseline to 6 months in diffusing capacity of the lung for carbon monoxide (DLCO)
Sponsors and contacts
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