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

NCT ID: NCT03176745

Last Updated: 2017-06-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 153 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-07-01
• Study Completion Date: 2017-01-15

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

Conditions

Healthy Controls; Chronic Obstructive Pulmonary Disease; Bronchial Asthma; Sarcoidosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

healthy controls

• no history of pulmonary disease
• absence of symptoms, smoking history < 10 pack years
• normal lung function testing

multiple breath washout

Intervention Type: DIAGNOSTIC_TEST

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

multiple breath washout

Intervention Type: DIAGNOSTIC_TEST

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

multiple breath washout

Intervention Type: DIAGNOSTIC_TEST

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

multiple breath washout

Intervention Type: DIAGNOSTIC_TEST

determination of lung clearance index using SF6 multiple breath washout

Interventions

multiple breath washout

determination of lung clearance index using SF6 multiple breath washout

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• informed consent

Exclusion Criteria

• inability to perform multiple breath washout testing

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universitätsmedizin Mannheim

OTHER

Sponsor Role: lead

Responsible Party

Dr. Frederik Trinkmann

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: DERIVED

PMID: 29228942 (View on PubMed)

Other Identifiers

MBW-number

Identifier Type: -

Identifier Source: org_study_id