Mind The Gap - Crossing Borders Study
EmphysemaCOPD1 moreRationale: A big step forward and great opportunity to improve overall efficacy of bronchoscopic lung volume reductioen is to combine treatment modalities aiming to close the dependent collateral channels and then proceed with EBV therapy to induce lobar collapse, and thus maximal treatment effect. Objective: Primary objective: To investigate the feasibility of injecting AeriSeal into the interlobar collateral ventilation channels region to make the target lobe suitable for endobronchial valve treatment. Secondary objectives: To investigate the safety of injecting AeriSeal into the interlobar collateral ventilation channels region to make the target lobe suitable for endobronchial valve treatment. To investigate the effectiveness of injecting AeriSeal into the interlobar collateral ventilation channels region to make the target lobe suitable for endobronchial valve treatment.
Lung Volume Reduction for Severe Emphysema by Stereotactic Ablative Radiation Therapy
EmphysemaSince medical therapies offer only modest palliation and minimal hopes for improved survival to COPD patients, surgical therapies have been designed that may provide greater benefits in selected patients. Lung transplantation, for example, clearly improves survival and quality of life in patients with end stage COPD. This comes at substantial economic cost, however, as well as the at the cost of complications that may result from the complex surgery and from life-long immunosuppression. In addition, nearly all lung transplants will fail within 5 years as a result of progressive bronchiolotis obliterans, which we currently have no way to prevent or treat. A second operation designed to treat severe COPD patients is lung volume reduction surgery (LVRS). This operation, designed for patients with predominant emphysema rather than chronic bronchitis, is among the most carefully studied operations ever developed. We believe that by reducing the volume of emphysematous lung with the precise target localization made possible by image-guided SABR, that we will be able to duplicate the benefits of surgical lung volume reduction with far less risk. We believe that this may represent a major advance in the therapy of emphysema - a highly prevalent disease. It may provide not only palliation but also increased survival, as does surgical lung volume reduction, in carefully selected patients.
Alvelestat (MPH966) for the Treatment of ALpha-1 ANTitrypsin Deficiency
Alpha-1 Antitrypsin Deficiency (AATD)Pi*ZZ4 moreThis is a Phase 2, multicenter, double-blind, randomized (1:1), placebo-controlled, 12-week, proof-of-concept study to evaluate the safety and tolerability as well as the mechanistic effect of oral administration of alvelestat (MPH966) in subjects with confirmed AATD defined as Pi*ZZ, Pi*SZ, Pi*null, or another rare phenotype/genotype known to be associated with either low (serum AAT level <11 μM or <57.2 mg/dL) or functionally impaired AAT including "F" or "I" mutations.
Efficacy and Safety of Alpha1-Proteinase Inhibitor (Human), Modified Process (Alpha-1 MP) in Subjects...
Pulmonary Emphysema in Alpha-1 PI DeficiencyThis is a multi-center, randomized, placebo-controlled, double blind clinical study to assess the efficacy and safety of two separate dose regimens of Alpha-1 MP versus placebo for 156 weeks (i.e., 3 years) using computed tomography (CT) of the lungs as the main measure of efficacy. The two Alpha-1 MP doses to be tested are 60 mg/kg and 120 mg/kg administered weekly by IV infusion for 156 weeks. The study consists of an optional pre-screening phase, Screening Phase, a 156-week Treatment Phase, and an End of Study Visit at Week 160.
Ultrasound and Respiratory Physiological Signals in Lung Diseases
Interstitial Lung DiseaseInterstitial Lung Diseases6 moreThe use of lung ultrasound is instrumental in the evaluation of many chest pathologies and its ability to detect pleuro-pulmonary pathology is widely accepted. However, the use of ultrasound to explore the state of the peripheral lung parenchyma, when the organ is still aerated, is a relatively new application. Horizontal and vertical artifacts are separate and distinct artifacts that can be seen during ultrasound examination of the lungs. While the practical role of lung ultrasound artifacts is accepted to detect and monitor many conditions, further research is needed for the physical interpretation of ultrasound artifacts. These artifacts are diagnostic signs, but we don't fully understand their origin. The artifactual information deriving from the surface acoustic interaction, beyond the pleural line, in the ultrasound images of the normally aerated and non-deflated lung, represents the final result of complex interactions of acoustic waves with a specific three-dimensional structure of the biological tissue. Thus, the umbrella term "vertical artifacts" oversimplifies many physical phenomena associated with a pathological pleural plane. There is growing evidence that vertical artifacts are caused by physiological and pathological changes in the superficial lung parenchyma. Therefore, the need emerges to explore the physical phenomena underlying the artifactual ultrasound information deriving from the surface acoustic interaction of ultrasound with the pleuro-pulmonary structures.
STRIVE Post-Market Registry Study
EmphysemaThis is a single-arm, prospective, multi-center, Registry study to evaluate the long-term safety and effectiveness of the Spiration Valve System (SVS) for the treatment of severe emphysema in a post-market setting.
Exploring the Utility of Hyperpolarized 129Xe MRI in Healthy Volunteers and Patients With Lung Disease...
AsthmaChronic Obstructive Pulmonary Disease7 moreThis is a single centre exploratory study that aims to apply hyperpolarized xenon-129 (129Xe) magnetic resonance imaging (MRI) methods and measurements in individual patients with and without lung disease to better understand lung structure and function and evaluate response to therapy delivered as a part of clinical care.
Zephyr Valve Registry (ZEVR)
EmphysemaThe purpose of this Post-Approval Registry is to gather ongoing safety and effectiveness assessment of the Zephyr Valve treatment in a real-world setting.
A Randomized Controlled Trial of InterVapor® in France - The TARGET Trial
EmphysemaThis study is designed to prospectively document changes in FEV1 and health-related quality of life 12 months following sequential segmental treatment with InterVapor® in patients with heterogeneous emphysema with upper lobe predominance. For validity of the study, the results will be compared to patients that receive optimal medical therapy.
Open Label Extension Study of INBRX-101 in Adults With AATD Emphysema
Alpha 1-Antitrypsin DeficiencyEmphysemaPhase 2 open label extension study to evaluate INBRX-101 in adults with AATD emphysema