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Evaluation of Novel Lung Function Parameters in Patients With Bronchial Asthma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03820427
Recruitment Status : Completed
First Posted : January 29, 2019
Last Update Posted : January 29, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Frederik Trinkmann, Universitätsmedizin Mannheim

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Bronchial Asthma Pulmonary Healthy Controls Diagnostic Test: impulse oscillometry Diagnostic Test: multiple breath washout test Diagnostic Test: body plethysmography

Study Design
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Study Type : Observational
Actual Enrollment : 147 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Evaluation of Novel Lung Function Parameters in Patients With Bronchial Asthma
Actual Study Start Date : August 2015
Actual Primary Completion Date : December 2018
Actual Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Groups and Cohorts
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Group/Cohort Intervention/treatment
bronchial asthma
Patients with known or suspected asthma.
 Diagnostic Test: impulse oscillometry
impulse oscillometry

Diagnostic Test: multiple breath washout test
multiple breath washout test

Diagnostic Test: body plethysmography
body plethysmography
pulmonary healthy controls
Patients without known or suspected pulmonary disease
 Diagnostic Test: impulse oscillometry
impulse oscillometry

Diagnostic Test: multiple breath washout test
multiple breath washout test

Diagnostic Test: body plethysmography
body plethysmography


Outcome Measures
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Primary Outcome Measures :
  1. Global ventilation heterogeneity [ Time Frame: 30 minutes ]
    lung clearance index (LCI) derived from sulphur hexafluoride multiple breath washout

  2. Local ventilation heterogeneity [ Time Frame: 30 minutes ]
    Sacin, Scond (Phase III slopes) derived from sulphur hexafluoride multiple breath washout


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
patients with indication for routine lung function testing
Criteria

Inclusion Criteria:

  • known or suspected bronchial asthma
  • known or suspected obstructive ventilation disorder
  • pulmonary healthy controls

Exclusion Criteria:

  • pregnancy
  • inability to participate
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Dr. Frederik Trinkmann, Principal Investigator, Universitätsmedizin Mannheim
ClinicalTrials.gov Identifier: NCT03820427    
Other Study ID Numbers: MBW-asthma
First Posted: January 29, 2019    Key Record Dates
Last Update Posted: January 29, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
 Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases