The Lung Microbiome and Endobronchial Valve Treatment

StatusActive, Not Recruiting
PhaseNot specified
Started

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Trial flagged as At Risk
Primary endpoint removed 3 → 2 primary endpoints
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Record History

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  1. Notable Primary endpoint(s) modified
    • Secondary endpoints: 1 to 6
    • Eligibility criteria expanded, about 2 words
  2. Notable Primary completion date: Jun 30, 2024 to Oct 30, 2026v2 Show 7 more changesShow less
    • Primary endpoints revised (3)
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Jun 30, 2025 to Jun 30, 2027
    • Secondary endpoint revised
    • Site details revised
    • Eligibility criteria expanded, about 1 word
    • Study description expanded, about 4 words
  3. Minor Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
1,120 trials monitored
See 36 trials at risk
Lung emphysema is an incurable disease and is often associated with chronic obstructive pulmonary disease (COPD). Dyspnea is the main, debilitating symptom and is relieved by inhaled bronchodilators and rehabilitation. However, a substantial number of patients continue to suffer from dyspnea, and among these, many patients have severe hyperinflated lungs due to emphysema. For selected patients, lung transplantation or lung volume reduction by surgical removal (LVRS) of the most emphysematous parts of the lungs can improve symptoms and survival. However, LVRS has a relatively large risk of adverse events, and therefore not all patients are suitable for surgery. An alternative to LVRS is bronchial lung volume reduction with endobronchial valves (EBV), where one-way valves are inserted in the bronchial system. It has emerged as a valid treatment option, with reduction of hyperinflation and increased pulmonary function, quality of life, and exercise capacity. The normal lung is colonized with several types of bacteria, and together these are called the microbiome. Some bacteria are potentially beneficial, while others are potentially harmful. After the insertion of EBVs, some patients develop chronic infections. The hypothesis is that the microbiome can affect the risk of chronic infection, and therefore the objective of this study is to assess the microbiome during the insertion of the EBVs and afterwards observe which patients develop chronic infection and whether these patients are harboring specific bacterial species.
Trial Details
NCT Number NCT04932811
Lead Sponsor Aarhus University Hospital
Conditions
(from sponsor)
Chronic Obstructive Pulmonary Disease, Emphysema
Related terms Emphysema, Pulmonary Disease, Chronic Obstructive
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov