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

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

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).

Study Overview

• Status: Completed
• Conditions: Healthy; COPD

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 Type: Observational
• Enrollment (Actual): 31

Contacts and Locations

• Study Contact: Name: Georg Nilius; Phone Number: +4920117422001; Email: G.nilius@kem-med.com
• Study Contact Backup: Name: Maik Schroeder; Phone Number: +4920117422057; Email: M.Schroeder@kem-med.com

Study Locations

• Germany
  • NRW
    • Essen, NRW, Germany, 45276
      • Kliniken Essen-Mitte, Evang. Huyssens-Stiftung/Knappschaft gGmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who are hospitalized in the Kliniken Essen Mitte

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sorption	Maximum water sorption per degree of saturation in percent of the dry mass weight of the mucus samples	5 days

Collaborators and Investigators

• Sponsor: Georg Nilius, Prof DR med

Study record dates

Study Major Dates

• Study Start (Actual): July 9, 2020
• Primary Completion (Actual): May 2, 2023
• Study Completion (Actual): May 17, 2023

Study Registration Dates

• First Submitted: January 7, 2021
• First Submitted That Met QC Criteria: January 7, 2021
• First Posted (Actual): January 11, 2021

Study Record Updates

• Last Update Posted (Actual): May 22, 2023
• Last Update Submitted That Met QC Criteria: May 19, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: mucociliary clearance; mucus; sorption of water
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Bronchitis
• Other Study ID Numbers: MUCUS2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No