Comparison of Water Sorption Capacity and the Composition of Bronchial Fluids of Healthy Persons and Patients With Chronic Obstructive Bronchitis (COPD)

Sponsor

Georg Nilius, Prof DR med (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04703023

Collaborator

(none)

Enrollment

Location

26.7

Anticipated Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Pilot basic research study on the properties of bronchial mucus. Examination of the sorption and desorption properties, mucin concentration, and structure of the mucus from healthy airways compared to patients with Chronic Obstructive Pulmonary Disease (COPD).

Condition or Disease	Intervention/Treatment	Phase
COPD Healthy

Detailed Description

Mucus, of the correct composition, maintains airway hydration and protects the airway from inhaled particles through mucociliary transport. In chronic inflammatory airway diseases such as COPD or cystic fibrosis, infectious agents, inflammatory cells and products of inflammation such as DNA, increase mucus viscosity which results in decreased mucociliary clearance of inhaled particles, increasing the likelihood of respiratory infections. This pilot study is planned as basic research on the properties of bronchial mucus.

Water isotherms and efficient water activity (sorption and desorption) of the collected samples are examined in defined temperature and humidity settings using DVS Intrinsic (Dynamic Vapour Sorption System, Surface Measurement Systems, London, UK). Findings will provide insights into possible treatment programs targeted at altering specific mucus components.

Study Design

Study Type:

Observational

Anticipated Enrollment :

60 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Vergleich Der Wasseraufnahmefähigkeit Und Zusammensetzung Von Bronchialflüssigkeiten Von Gesunden Und Patienten Mit Chronisch Obstruktiver Bronchitis (COPD)

Actual Study Start Date :

Jul 9, 2020

Anticipated Primary Completion Date :

Jul 1, 2022

Anticipated Study Completion Date :

Oct 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
COPD Secretions are collected from Bronchoscopy in clinical routine in COPD patients
lung healthy Secretions are collected from Removal of endotracheal tubes after elective surgery in lung healthy patients

Outcome Measures

Primary Outcome Measures

Sorption [5 days]
Maximum water sorption per degree of saturation in percent of the dry mass weight of the mucus samples

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age>18
COPD or other disease requiring bronchoscopy or elective surgery
Signed informed consent form

Exclusion Criteria:

Not able to consent
Linguistic, cognitive, or other obstacles

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kliniken Essen-Mitte, Evang. Huyssens-Stiftung/Knappschaft gGmbH	Essen	NRW	Germany	45276

Sponsors and Collaborators

Georg Nilius, Prof DR med

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Georg Nilius, Prof DR med, Clinical Director, Institut für Pneumologie Hagen Ambrock eV

ClinicalTrials.gov Identifier:

NCT04703023

Other Study ID Numbers:

MUCUS2020

First Posted:

Jan 11, 2021

Last Update Posted:

Sep 14, 2021

Last Verified:

Sep 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Georg Nilius, Prof DR med, Clinical Director, Institut für Pneumologie Hagen Ambrock eV

mucociliary clearance

mucus

sorption of water

Additional relevant MeSH terms:

Bronchitis

Study Results

No Results Posted as of Sep 14, 2021