Investigating the lung microbiome's impact on endobronchial valve treatment for emphysema
The Lung Microbiome in Patients With Emphysema and Chronic Obstructive Lung Disease Treated With Endobronchial Valves: Complications and Prognosis
Aarhus University Hospital · NCT04932811
This study is trying to see how the bacteria in the lungs affect the success and complications of a treatment for emphysema in patients with COPD who are getting endobronchial valves.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Aarhus University Hospital (other) |
| Locations | 1 site (Aarhus) |
| Trial ID | NCT04932811 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore how the lung microbiome affects outcomes and complications in patients with chronic obstructive pulmonary disease (COPD) and emphysema undergoing endobronchial valve (EBV) treatment. Patients will have bronchoalveolar lavage (BAL) performed before the insertion of EBVs, with the collected fluid analyzed for bacterial profiling. The study will track the incidence of infections and the need for valve removal or clean-up over a 24-month follow-up period, while also examining changes in the lung microbiome during these procedures.
Who should consider this trial
Good fit: Ideal candidates include COPD patients with emphysema who have been selected for EBV treatment by a multidisciplinary team.
Not a fit: Patients who have taken oral antibiotics within one month prior to the procedure may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of the lung microbiome's role in improving treatment outcomes for patients with emphysema undergoing EBV therapy.
How similar studies have performed: While the role of the lung microbiome in respiratory conditions is an emerging field, this specific approach to studying its impact on EBV treatment outcomes is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * COPD patients with emphysema selected for EBV treatment by multidiciplinary team, independent of this study. * Written informed consent Exclusion Criteria: - Intake of oral antibiotics within 1 month before the procedure. Patients receiving preventive long-term treatment with antibiotics can be included.
Where this trial is running
Aarhus
- Aarhus University Hospital — Aarhus, Denmark (RECRUITING)
Study contacts
- Study coordinator: Elisabeth Bendstrup, Professor
- Email: karbends@rm.dk
- Phone: +45 7846 2201
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Chronic Obstructive Pulmonary Disease, Emphysema