Obstructive Ventilation DisordersNCT02826226
Effect of Bronchodilatator Testing on Multiple-breath-washout (MBW) Derived Lung Function Parameters
An observational study of Obstructive Ventilation Disorders, run by Universitätsmedizin Mannheim at 1 site in Germany.
Trial summary
The investigators aim to evaluate the effect of bronchodilatator testing on multiple-breath-washout derived lung function parameters. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Ventilation Disorders
- What is being tested?
- multiple-breath-washout test and Bronchodilator Agents
- Type of treatment
- Medical device
- How many people
- 145 participants
- Where
- 1 siteGermany
- Study dates
- May 2016to Dec 2018
- 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 with known or suspected obstructive ventilation disorder and clinical indication for bronchodilator testing
Who may be able to join
- known or suspected obstructive ventilation disorder
- clinical indication for bronchodilator testing
Who cannot join
- pregnancy
- inability to participate
Trial locations and contacts
1 site in 1 country.
About this study
The investigators aim to evaluate the effect of bronchodilatator testing on multiple-breath-washout derived lung function parameters.
- Conditions
- Obstructive Ventilation Disorders
- Being tested
- multiple-breath-washout test, Bronchodilator Agents
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multiple-breath-washout testDevice
Bronchodilator AgentsDrug
| Study group | Role | What they receive |
|---|---|---|
| obstructive ventilation disorder | patients with known or suspected obstructive ventilation disorder and clinical indication for bronchodilator testing Receives: Device: multiple-breath-washout test; Drug: Bronchodilator Agents |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of lung clearance index (LCI) as determined by multiple breath washout
Measured: 60 minutes
Secondary outcomes (1)
repeatability of lung clearance index (LCI)
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2016 (estimated)
- Study startMay 2016
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Ventilation DisordersStudies 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
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 145 participants (actual)
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
- NCT02826226
- Sponsor's protocol ID
- MBW-bronchodilator
- Status last verified
- Dec 2018
- First submitted
- 30 Jun 2016
- Last updated
- 2 Jan 2019
- 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 2 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Bronchodilatator Testing on Multiple-breath-washout (MBW) Derived Lung Function Parameters
- ClinicalTrials.gov ID
- NCT02826226
- Acronym / sponsor ID
- MBW-bronchodilator
- Conditions
- Obstructive Ventilation Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Universitätsmedizin MannheimUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 7 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.
The investigators aim to evaluate the effect of bronchodilatator testing on multiple-breath-washout derived lung function parameters.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| obstructive ventilation disorder | – | Device: multiple-breath-washout test, Drug: Bronchodilator Agentspatients with known or suspected obstructive ventilation disorder and clinical indication for bronchodilator testing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with known or suspected obstructive ventilation disorder and clinical indication for bronchodilator testing
Key inclusion criteria (2 listed)
- known or suspected obstructive ventilation disorder
- clinical indication for bronchodilator testing
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 |
|---|---|---|
| multiple-breath-washout test | Device | obstructive ventilation disorder |
| Bronchodilator Agents | Drug | obstructive ventilation disorder |
Primary outcome
change of lung clearance index (LCI) as determined by multiple breath washout
Time frame: 60 minutes
1 secondary outcome
repeatability of lung clearance index (LCI)
Time frame: 60 minutes
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 2 Jan 2019.
- 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 Obstructive Ventilation Disorders, 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 2 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 2 Jan 2019. 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?
change of lung clearance index (LCI) as determined by multiple breath washout (time frame: 60 minutes). 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 2 Jan 2019.