COPDNCT02827721
Evaluation of Novel Lung Function Parameters in Patients With Chronic Obstructive Pulmonary Disease (COPD)
An observational study of COPD and Obstructive Ventilation Disorder, run by Universitätsmedizin Mannheim at 1 site in Germany.
Trial summary
Current guideline-based criteria defining COPD do not meet the challenges set by the complex pathophysiology of the disease. The investigators therefore aimed to evaluate novel or not widely used diagnostic approaches for the detection and therapeutic monitoring of COPD. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COPD, Obstructive Ventilation Disorder, Pulmonary Emphysema
- What is being tested?
- impulse oscillometry, multiple breath washout test and body plethysmography
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2015to Nov 2020
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients with indication for routine lung function testing
Who may be able to join
- known or suspected COPD
- known or suspected obstructive ventilation disorder
- pulmonary healthy controls
Who cannot join
- pregnancy
- inability to participate
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Medical Center Mannheim
Mannheim, 68167
Frederik Trinkmann, Dr., +496213833879, frederik.trinkmann@umm.de
Frederik Trinkmann, Dr.
About this study
Current guideline-based criteria defining COPD do not meet the challenges set by the complex pathophysiology of the disease. The investigators therefore aimed to evaluate novel or not widely used diagnostic approaches for the detection and therapeutic monitoring of COPD.
- Conditions
- COPD, Obstructive Ventilation Disorder, Pulmonary Emphysema
- Being tested
- impulse oscillometry, multiple breath washout test, body plethysmography
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Pulmonary Emphysema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
impulse oscillometryDevice
multiple breath washout testDevice
body plethysmographyDevice
| Study group | Role | What they receive |
|---|---|---|
| COPD | Patients with known or suspected COPD Patients with known or suspected obstructive ventilation disorder Receives: Device: impulse oscillometry; Device: multiple breath washout test; Device: body plethysmography | |
| pulmonary healthy controls | Patients without known or suspected pulmonary disease Receives: Device: impulse oscillometry; Device: multiple breath washout test; Device: body plethysmography |
What is being measured
The primary outcome is the main question the study is designed to answer.
lung clearance index (LCI) as determined by multiple breath washout
Measured: 30 minutes
airway resistance and reactance (R5, X5, R-D5-20) as determined by impulse oscillometry
Measured: 30 minutes
Secondary outcomes (1)
repeatability of lung clearance index (LCI)
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2016 (estimated)
- Study startJul 2015
- Primary completionNov 2020 (estimated)
- Study completionNov 2020 (estimated)
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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitätsmedizin Mannheim
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Frederik Trinkmann, Universitätsmedizin Mannheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02827721
- Sponsor's protocol ID
- MBW-COPD
- Status last verified
- Mar 2020
- First submitted
- 30 Jun 2016
- Last updated
- 24 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Novel Lung Function Parameters in Patients With Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT02827721
- Acronym / sponsor ID
- MBW-COPD
- Conditions
- COPD, Obstructive Ventilation Disorder, Pulmonary Emphysema
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Universitätsmedizin MannheimUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Nov 2020 (estimated)
- Study completion
- Nov 2020 (estimated)
- First posted
- 11 Jul 2016 (estimated)
- 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.
Current guideline-based criteria defining COPD do not meet the challenges set by the complex pathophysiology of the disease. The investigators therefore aimed to evaluate novel or not widely used diagnostic approaches for the detection and therapeutic monitoring of COPD.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COPD | – | Device: impulse oscillometry, Device: multiple breath washout test, Device: body plethysmographyPatients with known or suspected COPD Patients with known or suspected obstructive ventilation disorder |
| pulmonary healthy controls | – | Device: impulse oscillometry, Device: multiple breath washout test, Device: body plethysmographyPatients without known or suspected pulmonary disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients with indication for routine lung function testing
Key inclusion criteria (3 listed)
- known or suspected COPD
- known or suspected obstructive ventilation disorder
- pulmonary healthy controls
Key exclusion criteria (2 listed)
- pregnancy
- inability to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| impulse oscillometry | Device | COPD, pulmonary healthy controls |
| multiple breath washout test | Device | COPD, pulmonary healthy controls |
| body plethysmography | Device | COPD, pulmonary healthy controls |
Primary outcome
lung clearance index (LCI) as determined by multiple breath washout
Time frame: 30 minutes
airway resistance and reactance (R5, X5, R-D5-20) as determined by impulse oscillometry
Time frame: 30 minutes
1 secondary outcome
repeatability of lung clearance index (LCI)
Time frame: 30 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2020.
- 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.
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 Obstructive Ventilation Disorder, run by Universitätsmedizin Mannheim 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: status not confirmed, as of the sponsor's last update on 24 Mar 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Frederik Trinkmann, Dr. (+496213833879, frederik.trinkmann@umm.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
lung clearance index (LCI) as determined by multiple breath washout (time frame: 30 minutes). The study lists 2 primary outcomes in all. 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 24 Mar 2020.