We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Number of Multiple Breath Washout Tests in Adults With Pulmonary Disease and Healthy Controls

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03176745
First Posted: June 5, 2017
Last Update Posted: June 5, 2017
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.
Information provided by (Responsible Party):
Dr. Frederik Trinkmann, Universitätsmedizin Mannheim
  Purpose
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

Condition Intervention
Healthy Controls Chronic Obstructive Pulmonary Disease Bronchial Asthma Sarcoidosis Diagnostic Test: multiple breath washout

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Determination of the Optimal Number of Multiple Breath Washout Tests in Adults With Pulmonary Disease and Healthy Controls

Resource links provided by NLM:


Further study details as provided by Dr. Frederik Trinkmann, Universitätsmedizin Mannheim:

Primary Outcome Measures:
  • 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


Enrollment: 153
Actual Study Start Date: July 1, 2015
Study Completion Date: January 15, 2017
Primary Completion Date: June 30, 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
healthy controls
  • no history of pulmonary disease
  • absence of symptoms, smoking history < 10 pack years
  • normal lung function testing
Diagnostic Test: multiple breath washout
determination of lung clearance index using SF6 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
Diagnostic Test: multiple breath washout
determination of lung clearance index using SF6 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
Diagnostic Test: multiple breath washout
determination of lung clearance index using SF6 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
Diagnostic Test: multiple breath washout
determination of lung clearance index using SF6 multiple breath washout

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
inpatients, outpatients, students, employees
Criteria

Inclusion criteria:

- informed consent

Exclusion Criteria:

  • inability to perform multiple breath washout testing
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Dr. Frederik Trinkmann, Principal Investigator, Universitätsmedizin Mannheim
ClinicalTrials.gov Identifier: NCT03176745     History of Changes
Other Study ID Numbers: MBW-number
First Submitted: June 2, 2017
First Posted: June 5, 2017
Last Update Posted: June 5, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Sarcoidosis
Asthma
Respiratory Tract Diseases
Lymphoproliferative Disorders
Lymphatic Diseases
Bronchial Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases