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NCT Number: NCT06629558

Bronchoscopic Lung Volume Reduction in Management of Localized Emphysema

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.

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Key information

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mohamed AbdElmoniem

Al Mansurah, 35516, Egypt

Location status: Recruiting

Location contact

Farid Abd-Elreheim Badria

SUB_INVESTIGATOR

Mahamoud Elhosiny

CONTACT

[email protected]

01014008473

Mahmoud Mostafa Elhosiny

SUB_INVESTIGATOR

Mohamed AbdElmoniem

CONTACT

[email protected]

01014008473

Mohammad Khairy El-Badrawy

SUB_INVESTIGATOR

Nihal Magdy El Batouty

SUB_INVESTIGATOR

About this study

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.

Chemical lung volume reduction is an endo-bronchial approach, which uses chemical agents aiming to reduce lung volume by blocking off the most emphysematous areas with a rapidly polymerizing sealant. Endobronchial Valves (EBVs) show an overall success rate of 70-80% in reducing lung volume and improving lung function. Lung volume reduction coils (LVRC-Coils) have a success rate of 50-60%.

Bronchoscopic lung volume reduction with silver nitrate as a chemical agent was used in previous studies using a concentration of 0.5% and showed significant improvement in forced expiratory volume in first second (FEV1), diffusion capacity of lung to carbon monoxide (DLCo), modified Medical Research Council (mMRC) score when compared to base line values and reduction of the High Resolution Computed Tomography (HRCT) volumetry of the emphysematous regions.

Silver nanoparticles (AgNPs) are the most widely used nanomaterial today. These have found a wide range of applications in various areas such as textiles, agriculture, renewable energy, food, catalysis, bioremediation, and biomedicine

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • Associated lung fibrosis.
  • FEV1 > 60%.
  • Current smoker.

Treatment and study plan

Silver Nitrate

Drug

bronchoscopic lung volume reduction in management of localized emphysema

Other names: 0.5% w/v Silver nitrate solution

Nano-silver nitrate

Drug

bronchoscopic lung volume reduction in management of localized emphysema

Other names: 0.5% w/v Nano-silver nitrate solution

Bronchoscopic lung volume reduction

Device

bronchoscopic lung volume reduction in management of localized emphysema

Other names: Bronchoscopy

Primary outcomes

  1. Residual volume/ Total lung capacity (RV/TLC) ratio and volumetry

    Time frame: 6 months

    RV/TLC ratio measured at 6 months following treatment. Treatment success is defined as a statistically significant reduction in RV/TLC and from baseline.

  2. change in Forced expiratory volume at first second (FEV1) and Forced vital capacity (FVC)

    Time frame: 6 months

    change from baseline to 6 months in FEV1 and FVC,

  3. Voluometry

    Time frame: 6 months

    Voluometry measured at 6 months following treatment. Treatment success is defined as a statistically significant reduction in voluometry and from baseline.

  4. diffusing capacity of the lung for carbon monoxide (DLCO)

    Time frame: 6 months

    change from baseline to 6 months in diffusing capacity of the lung for carbon monoxide (DLCO)

Study contacts

Contact information is provided by the study sponsor or research team.

Mohamed AbdElmoniem

CONTACT

[email protected]

01014008473

Sponsors and collaborators

Lead sponsor

Mansoura University Hospital

Other

Registry information

Official study title

Efficacy and Safety of 0.5% w/v Nano- Silver Nitrate Versus Silver Nitrate Solution for Bronchoscopic Lung Volume Reduction in Management of Localized Emphysema: Prospective Interventional Randomized Controlled Clinical Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Oct 8, 2024
Registry last updated
May 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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