NCT05846620

Brief Summary

The overall aim is to to provide a normal material for the composition and spatial heterogeneity of the following in the healthy lung: i) immune cell populations and their activation patterns, ii) the surrounding cytokine-chemokine milieu, including trans-compartmental fluxes of these mediators between the lung and bloodstream, and iii) the lung microbiome. Main hypotheses:

  • Absolute and relative immune cell counts in bronchoalveolar lavage fluid (BALF) are similar to those previously reported by other methods6,7.
  • No trans-compartmental flux of cytokines between the lungs and bloodstream is present, but cytokine concentrations (notably IL-6 and IL-8) vary with the immune-cell-microbiome composition.
  • Immune cell (mainly T cell) activation, differentiation, and gene expression patterns are expected to differ between blood and BALF in a manner that depends on the regional diversity of the pulmonary microbiome.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
31mo left

Started Apr 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress54%
Apr 2023Nov 2028

Study Start

First participant enrolled

April 17, 2023

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

April 27, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 6, 2023

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2028

Last Updated

March 17, 2025

Status Verified

March 1, 2025

Enrollment Period

5.6 years

First QC Date

April 27, 2023

Last Update Submit

March 13, 2025

Conditions

Healthy

Keywords

healthy lung, lung microbiota, microbiome

Outcome Measures

Primary Outcomes (2)

  • Lung microbiome

    16S ribosomal RNA (rRNA) and 18S rRNA PCR for bacterial or fungal pathogen identification in bronchoalveolar lavage fluid

    Day 0 (subsequent to study inclusion)

  • Lymphocyte populations

    Cell populations and subpopulations evaluated by 10 colored flow cytometry (B cells, T cells, TCR subsets, Tregs/Th17, dendritic cells, myeloid cells and neutrophils) in bronchoalveolar lavage fluid and blood

    Day 0 (subsequent to study inclusion)

Secondary Outcomes (7)

  • Cell differential counts and cytomorphological analyses of BALF

    Day 0 (subsequent to study inclusion)

  • Trans-compartmental fluxes

    Day 0 (subsequent to study inclusion)

  • Auto-antibodies against tI-IFNs in blood

    Day 0 (subsequent to study inclusion)

  • White blood cells counts

    Day 0 (subsequent to study inclusion)

  • Cytokines

    Day 0 (subsequent to study inclusion)

  • +2 more secondary outcomes

Study Arms (2)

Women

Procedure: Bronchoalveolar lavage

Men

Procedure: Bronchoalveolar lavage

Interventions

Bronchoalveolar lavagePROCEDURE

Bronchoalveolar lavage in the middle lobe of the right lung and a mini-bronchoalveolar lavage in the upper and lower lobe of the right lung

MenWomen

Eligibility Criteria

Age40 Years - 75 Years
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients referred for elective surgery requiring intubation at Hvidovre Hospital

You may qualify if:

  • Men and women
  • Age 40 to 75

You may not qualify if:

  • Immune deficiency
  • Lung disease
  • Active cancer or infection
  • Absolute contraindications for bronchoscopy
  • Untreated malignant arrhythmia
  • Documented or suspected intracranial hypertension (intracranial pressure ≥ \> 15 mmHg)
  • One-lung ventilation
  • Severe coagulopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hvidovre Hospital, University of Copenhagen

Hvidovre, 2650, Denmark

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, plasma, BAL fluid, endotracheal aspirate, oral/nasal swab

MeSH Terms

Interventions

Bronchoalveolar Lavage

Intervention Hierarchy (Ancestors)

Therapeutic IrrigationInvestigative Techniques

Study Officials

  • Ronan Berg, MD PhD

    Biomedical Science of Health, University of Copenhagen

    STUDY CHAIR

Central Study Contacts

Ronni Plovsing, MD, PhD

CONTACT

+45386220721ronni.thermann.reitz.plovsing.01@regionh.dk

Katrine Schneider, MD

CONTACT

+4528118147katrine.schneider@regionh.dk

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor, Senior Consultant of ICU

Study Record Dates

First Submitted

April 27, 2023

First Posted

May 6, 2023

Study Start

April 17, 2023

Primary Completion (Estimated)

November 30, 2028

Study Completion (Estimated)

November 30, 2028

Last Updated

March 17, 2025

Record last verified: 2025-03

Locations

DK(1)