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The influence of the order of spirometry and multiple breath washout on the outcome in patients with cystic fibrosis an primary ciliary dyskinesia

The influence of the order of spirometry and multiple breath washout on the outcome in patients with cystic fibrosis an primary ciliary dyskinesia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00027473
Enrollment
44
Registered
2022-06-20
Start date
2021-06-08
Completion date
Unknown
Last updated
2025-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

E84 Q34

Interventions

Group 1: Patients are randomised into two groups. Group 1 performed the lung function test on the first study date in this order: 1. Multiple Breath Washout, 2. Spirometrie (A). Time between the two t

Sponsors

Klinik für Kinder- und Jugendmedizin, Universitätsklinikum der Ruhr-Universität Bochum
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to No maximum

Inclusion criteria

Inclusion criteria: - Age > 6 years - genetically approved cystic fibrosis (CF) or approved Primary ciliary dyskinesia (PCD) after ERS-criteria (min. PCD highly likely) - regularly participation in the ambulance appointments in the CF- or PCD-consulting hours in the last 12 month with appointments every 3 month

Exclusion criteria

Exclusion criteria: - missing consent of the patients respectively their custody if underaged - the custody does not speak German - missing cooperation in the measurement procedure of the lung function diagnosis - acute exacerbation/decrease two weeks before study inclusion - regularly participation in the ambulance appointments every 3 month is not guarenteed - forced expiratory volume (FEV1) <60%

Design outcomes

Primary

MeasureTime frame
the primary outcome was defined as the change in the z-Score of forced expiratory volume after 1 second (FEV1), if multiple breath washout was performed before spirometry.

Secondary

MeasureTime frame
the secondary outcome was defined as the change in the test results of the multiple breath washout (Lung Clearance Index (LCI2,5%)), if spirometry was performed before multiple breath washout.

Countries

Germany

Contacts

Public ContactAnne Schlegtendal

Abteilung für Pädiatrische PneumologieKlinik für Kinder- und Jugendmedizin im Katholischen Klinikum BochumUniversitätsklinik der Ruhr-Universität-Bochum

anne.schlegtendal@rub.de0234 5092611

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026