NCT04703023

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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

July 9, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 7, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 11, 2021

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 2, 2023

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 17, 2023

Completed
Last Updated

May 22, 2023

Status Verified

May 1, 2023

Enrollment Period

2.8 years

First QC Date

January 7, 2021

Last Update Submit

May 19, 2023

Conditions

COPDHealthy

Keywords

mucociliary clearancemucussorption of water

Outcome Measures

Primary Outcomes (1)

  • Sorption

    Maximum water sorption per degree of saturation in percent of the dry mass weight of the mucus samples

    5 days

Study Arms (2)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who are hospitalized in the Kliniken Essen Mitte

You may qualify if:

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

You may not qualify if:

  • Not able to consent
  • Linguistic, cognitive, or other obstacles

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kliniken Essen-Mitte, Evang. Huyssens-Stiftung/Knappschaft gGmbH

Essen, North Rhine-Westphalia, 45276, Germany

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Director

Study Record Dates

First Submitted

January 7, 2021

First Posted

January 11, 2021

Study Start

July 9, 2020

Primary Completion

May 2, 2023

Study Completion

May 17, 2023

Last Updated

May 22, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)