COPDNCT04703023
Comparison of Water Sorption Capacity and the Composition of Bronchial Fluids of Healthy Persons and Patients With Chronic Obstructive Bronchitis (COPD)
An observational study of COPD and Healthy, run by Georg Nilius, Prof DR med at 1 site in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- How many people
- 31 participants
- Where
- 1 siteGermany
- Study dates
- 9 Jul 2020to 17 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are hospitalized in the Kliniken Essen Mitte
Who may be able to join
- Age>18
- COPD or other disease requiring bronchoscopy or elective surgery
- Signed informed consent form
Who cannot join
- Not able to consent
- Linguistic, cognitive, or other obstacles
Trial locations and contacts
1 site in 1 country.
Germany1 site
Kliniken Essen-Mitte, Evang. Huyssens-Stiftung/Knappschaft gGmbH
Essen, North Rhine-Westphalia, 45276
About this study
Official title: 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).
Read the 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.
- Keywords
- mucociliary clearance, mucus, sorption of water
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Sorption
Maximum water sorption per degree of saturation in percent of the dry mass weight of the mucus samples
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2021
- Study start9 Jul 2020
- Primary completion2 May 2023
- Study completion17 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georg Nilius, Prof DR med
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, Georg Nilius, Prof DR med, Institut für Pneumologie Hagen Ambrock eV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04703023
- Sponsor's protocol ID
- MUCUS2020
- Status last verified
- May 2023
- First submitted
- 7 Jan 2021
- Last updated
- 22 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vergleich Der Wasseraufnahmefähigkeit Und Zusammensetzung Von Bronchialflüssigkeiten Von Gesunden Und Patienten Mit Chronisch Obstruktiver Bronchitis (COPD)
- ClinicalTrials.gov ID
- NCT04703023
- Acronym / sponsor ID
- MUCUS2020
- Keywords
- mucociliary clearance, mucus, sorption of water
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Georg Nilius, Prof DR medIndustry (pharma, biotech, devices)
- Study start
- 9 Jul 2020 (actual)
- Primary completion
- 2 May 2023 (actual)
- Study completion
- 17 May 2023 (actual)
- First posted
- 11 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are hospitalized in the Kliniken Essen Mitte
Key inclusion criteria (3 listed)
- Age>18
- COPD or other disease requiring bronchoscopy or elective surgery
- Signed informed consent form
Key exclusion criteria (2 listed)
- Not able to consent
- Linguistic, cognitive, or other obstacles
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sorption
Time frame: 5 days
Maximum water sorption per degree of saturation in percent of the dry mass weight of the mucus samples
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD and Healthy, run by Georg Nilius, Prof DR med at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sorption (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2023; AzTrials last refreshed its copy on 8 Nov 2026.