Healthy ControlsNCT03176745
Number of Multiple Breath Washout Tests in Adults With Pulmonary Disease and Healthy Controls
An observational study of Healthy Controls and Chronic Obstructive Pulmonary Disease, run by Universitätsmedizin Mannheim.
Trial summary
The investigators aim to determine the optimal number of measurements required for multiple-breath-washout derived lung function parameters in adults with pulmonary disease as well as in healthy controls Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Controls, Chronic Obstructive Pulmonary Disease, Bronchial Asthma
- What is being tested?
- multiple breath washout
- How many people
- 153 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2015to 15 Jan 2017
- 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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: inpatients, outpatients, students, employees
Who may be able to join
- informed consent
Who cannot join
- inability to perform multiple breath washout testing
About this study
Official title: Determination of the Optimal Number of Multiple Breath Washout Tests in Adults With Pulmonary Disease and Healthy Controls
The investigators aim to determine the optimal number of measurements required for multiple-breath-washout derived lung function parameters in adults with pulmonary disease as well as in healthy controls
- Being tested
- multiple breath washout
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Asthma, Sarcoidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multiple breath washoutDiagnostic test
determination of lung clearance index using SF6 multiple breath washout
| Study group | Role | What they receive |
|---|---|---|
| healthy controls | * no history of pulmonary disease
* absence of symptoms, smoking history < 10 pack years
* normal lung function testing Receives: Diagnostic Test: multiple breath washout | |
| chronic obstructive pulmonary disease | * clinical history and/or specialist diagnosis of COPD and risk factor(s)
* persistent bronchial obstruction and/or hyperinflation and/or radiological sign of emphysema, each without alternative explanation
* dyspnea, cough and/or sputum production Receives: Diagnostic Test: multiple breath washout | |
| bronchial asthma | * clinical history and/or specialist diagnosis of bronchial asthma
* respiratory symptoms compatible with asthma varying over time
* variable and/or reversible obstructive ventilation disorder and/or airway hyperresponsiveness
* exclusion of alternative explanation Receives: Diagnostic Test: multiple breath washout | |
| sarcoidosis | * clinical history and/or specialist diagnosis of sarcoidosis
* lymphocytic alveolitis and CD4/CD8 > 3.5 in bronchoalveolar lavage and/or noncaseating epithelioid granuloma
* exclusion of alternative explanation Receives: Diagnostic Test: multiple breath washout |
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
comparing the repeatability of duplicate vs. triplicate LCI measurements
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 posted5 Jun 2017
- Study start1 Jul 2015
- Primary completion30 Jun 2016
- Study completion15 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy ControlsStudies 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
- 153 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
- NCT03176745
- Sponsor's protocol ID
- MBW-number
- Status last verified
- Jun 2017
- First submitted
- 2 Jun 2017
- Last updated
- 5 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Trinkmann F, Gotzmann J, Saur D, Schroeter M, Roth K, Stach K, Borggrefe M, Saur J, Akin I, Michels JD. Multiple breath washout testing in adults with pulmonary disease and healthy controls - can fewer measurements eventually be more? BMC Pulm Med. 2017 Dec 11;17(1):185. doi: 10.1186/s12890-017-0543-y.
PubMed 29228942
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Optimal Number of Multiple Breath Washout Tests in Adults With Pulmonary Disease and Healthy Controls
- ClinicalTrials.gov ID
- NCT03176745
- Acronym / sponsor ID
- MBW-number
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Universitätsmedizin MannheimUniversity, hospital or other
- Study start
- 1 Jul 2015 (actual)
- Primary completion
- 30 Jun 2016 (actual)
- Study completion
- 15 Jan 2017 (actual)
- First posted
- 5 Jun 2017 (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.
The investigators aim to determine the optimal number of measurements required for multiple-breath-washout derived lung function parameters in adults with pulmonary disease as well as in healthy controls
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| healthy controls | – | Diagnostic Test: multiple breath washout* no history of pulmonary disease * absence of symptoms, smoking history < 10 pack years * normal lung function testing |
| chronic obstructive pulmonary disease | – | Diagnostic Test: multiple breath washout* clinical history and/or specialist diagnosis of COPD and risk factor(s) * persistent bronchial obstruction and/or hyperinflation and/or radiological sign of emphysema, each without alternative explanation * dyspnea, cough and/or sputum production |
| bronchial asthma | – | Diagnostic Test: multiple breath washout* clinical history and/or specialist diagnosis of bronchial asthma * respiratory symptoms compatible with asthma varying over time * variable and/or reversible obstructive ventilation disorder and/or airway hyperresponsiveness * exclusion of alternative explanation |
| sarcoidosis | – | Diagnostic Test: multiple breath washout* clinical history and/or specialist diagnosis of sarcoidosis * lymphocytic alveolitis and CD4/CD8 > 3.5 in bronchoalveolar lavage and/or noncaseating epithelioid granuloma * exclusion of alternative explanation |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- inpatients, outpatients, students, employees
Key inclusion criteria (1 listed)
- informed consent
Key exclusion criteria (1 listed)
- inability to perform multiple breath washout testing
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 washoutdetermination of lung clearance index using SF6 multiple breath washout | Diagnostic test | bronchial asthma, chronic obstructive pulmonary disease, healthy controls, sarcoidosis |
Primary outcome
change of lung clearance index (LCI) as determined by multiple breath washout
Time frame: 60 minutes
comparing the repeatability of duplicate vs. triplicate LCI measurements
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 5 Jun 2017.
- Derived from this study: PubMed 29228942Trinkmann F, Gotzmann J, Saur D, Schroeter M, Roth K, Stach K, Borggrefe M, Saur J, Akin I, Michels JD. Multiple breath washout testing in adults with pulmonary disease and healthy controls - can fewer measurements eventually be more? BMC Pulm Med. 2017 Dec 11;17(1):185. doi: 10.1186/s12890-017-0543-y.
- 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 Healthy Controls and Chronic Obstructive Pulmonary Disease, 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 1 inclusion and 1 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 5 Jun 2017. 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?
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?
On the ClinicalTrials.gov record for NCT03176745, which also lists 1 linked publication.
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 5 Jun 2017.