Bronchial AsthmaNCT03820427
Evaluation of Novel Lung Function Parameters in Patients With Bronchial Asthma
An observational study of Bronchial Asthma and Pulmonary Healthy Controls, run by Universitätsmedizin Mannheim.
Trial summary
Current guideline-based criteria defining bronchial asthma do not always meet the challenges set by the complex pathophysiology of the disease. The investigators therefore aimed to evaluate novel or not widely used functional diagnostic approaches for the detection and therapeutic monitoring of patients with asthma. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bronchial Asthma, Pulmonary Healthy Controls
- What is being tested?
- impulse oscillometry, multiple breath washout test and body plethysmography
- How many people
- 147 participants
- Where
- No sites listed yet
- Study dates
- Aug 2015to 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
- 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 bronchial asthma
- known or suspected obstructive ventilation disorder
- pulmonary healthy controls
Who cannot join
- pregnancy
- inability to participate
About this study
Current guideline-based criteria defining bronchial asthma do not always meet the challenges set by the complex pathophysiology of the disease. The investigators therefore aimed to evaluate novel or not widely used functional diagnostic approaches for the detection and therapeutic monitoring of patients with asthma.
- Conditions
- Bronchial Asthma, Pulmonary Healthy Controls
- Being tested
- impulse oscillometry, multiple breath washout test, body plethysmography
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
impulse oscillometryDiagnostic test
impulse oscillometry
multiple breath washout testDiagnostic test
multiple breath washout test
body plethysmographyDiagnostic test
body plethysmography
| Study group | Role | What they receive |
|---|---|---|
| bronchial asthma | Patients with known or suspected asthma. Receives: Diagnostic Test: impulse oscillometry; Diagnostic Test: multiple breath washout test; Diagnostic Test: body plethysmography | |
| pulmonary healthy controls | Patients without known or suspected pulmonary disease Receives: Diagnostic Test: impulse oscillometry; Diagnostic Test: multiple breath washout test; Diagnostic Test: body plethysmography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global ventilation heterogeneity
lung clearance index (LCI) derived from sulphur hexafluoride multiple breath washout
Measured: 30 minutes
Local ventilation heterogeneity
Sacin, Scond (Phase III slopes) derived from sulphur hexafluoride multiple breath washout
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 posted29 Jan 2019
- Study startAug 2015
- 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 Bronchial AsthmaStudies 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
- Cross-sectional
- Enrolment
- 147 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
- NCT03820427
- Sponsor's protocol ID
- MBW-asthma
- Status last verified
- Jan 2019
- First submitted
- 22 Jan 2019
- Last updated
- 29 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- 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 29 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Novel Lung Function Parameters in Patients With Bronchial Asthma
- ClinicalTrials.gov ID
- NCT03820427
- Acronym / sponsor ID
- MBW-asthma
- Conditions
- Bronchial Asthma, Pulmonary Healthy Controls
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- Universitätsmedizin MannheimUniversity, hospital or other
- Study start
- Aug 2015 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 29 Jan 2019 (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.
Current guideline-based criteria defining bronchial asthma do not always meet the challenges set by the complex pathophysiology of the disease. The investigators therefore aimed to evaluate novel or not widely used functional diagnostic approaches for the detection and therapeutic monitoring of patients with asthma.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bronchial asthma | – | Diagnostic Test: impulse oscillometry, Diagnostic Test: multiple breath washout test, Diagnostic Test: body plethysmographyPatients with known or suspected asthma. |
| pulmonary healthy controls | – | Diagnostic Test: impulse oscillometry, Diagnostic Test: multiple breath washout test, Diagnostic Test: 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 bronchial asthma
- 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 oscillometryimpulse oscillometry | Diagnostic test | bronchial asthma, pulmonary healthy controls |
| multiple breath washout testmultiple breath washout test | Diagnostic test | bronchial asthma, pulmonary healthy controls |
| body plethysmographybody plethysmography | Diagnostic test | bronchial asthma, pulmonary healthy controls |
Primary outcome
Global ventilation heterogeneity
Time frame: 30 minutes
lung clearance index (LCI) derived from sulphur hexafluoride multiple breath washout
Local ventilation heterogeneity
Time frame: 30 minutes
Sacin, Scond (Phase III slopes) derived from sulphur hexafluoride multiple breath washout
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 29 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchial Asthma and Pulmonary Healthy Controls, run by Universitätsmedizin Mannheim.
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 29 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Global ventilation heterogeneity (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 29 Jan 2019.