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

Completed

• Conditions: Bronchial Asthma; Healthy Controls; Sarcoidosis; Chronic Obstructive Pulmonary Disease
• Interventions: Diagnostic Test: multiple breath washout

• Registration Number: NCT03176745
• Lead Sponsor: Universitätsmedizin Mannheim

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07-01
• Primary Completion: 2016-06-30
• Study Completion: 2017-01-15
• Status Verified: 2017-06
• Study First Submitted: 2017-06-02
• Study First Submitted QC: 2017-06-02
• Last Update Submitted: 2017-06-02
• Study First Posted: 2017-06-05
• Last Update Posted: 2017-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 153

Inclusion Criteria

Not provided

Exclusion Criteria

• inability to perform multiple breath washout testing

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
healthy controls	multiple breath washout	* no history of pulmonary disease * absence of symptoms, smoking history \< 10 pack years * normal lung function testing
chronic obstructive pulmonary disease	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
sarcoidosis	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
bronchial asthma	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

Primary Outcome Measures

Name	Time	Method
change of lung clearance index (LCI) as determined by multiple breath washout	60 minutes	comparing the repeatability of duplicate vs. triplicate LCI measurements