Evaluation of Novel Lung Function Parameters in Patients With Bronchial Asthma
January 27, 2019 updated by: Dr. Frederik Trinkmann, Universitätsmedizin Mannheim
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 Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
147
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
patients with indication for routine lung function testing
Description
Inclusion Criteria:
- known or suspected bronchial asthma
- known or suspected obstructive ventilation disorder
- pulmonary healthy controls
Exclusion Criteria:
- pregnancy
- inability to participate
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
bronchial asthma
Patients with known or suspected asthma.
|
impulse oscillometry
multiple breath washout test
body plethysmography
|
|
pulmonary healthy controls
Patients without known or suspected pulmonary disease
|
impulse oscillometry
multiple breath washout test
body plethysmography
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Global ventilation heterogeneity
Time Frame: 30 minutes
|
lung clearance index (LCI) derived from sulphur hexafluoride multiple breath washout
|
30 minutes
|
|
Local ventilation heterogeneity
Time Frame: 30 minutes
|
Sacin, Scond (Phase III slopes) derived from sulphur hexafluoride multiple breath washout
|
30 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2015
Primary Completion (Actual)
December 1, 2018
Study Completion (Actual)
December 1, 2018
Study Registration Dates
First Submitted
January 22, 2019
First Submitted That Met QC Criteria
January 27, 2019
First Posted (Actual)
January 29, 2019
Study Record Updates
Last Update Posted (Actual)
January 29, 2019
Last Update Submitted That Met QC Criteria
January 27, 2019
Last Verified
January 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MBW-asthma
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.