Changes in FeNO Value During Pulmonary Rehabilitation in Patients with Asthma

Completed

• Conditions: Asthma Bronchiale; Asthmatic Patients; Asthmatics

• Registration Number: NCT06751550
• Lead Sponsor: Schön Klinik Berchtesgadener Land

Brief Summary

This study investigates the use of fractional exhaled nitric oxide (FeNO) measurement to monitor non-pharmacological therapy during a three-week inpatient rehabilitation programme for asthma patients. It compares FeNO levels (measured three times a day) with clinical parameters and quality of life to analyse daily fluctuations and the acute effect of exercise training on FeNO levels. As FeNO is a non-invasive biomarker of airway inflammation, this study aims to expand its role in therapy monitoring and explore its application in a rehabilitation setting.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-17
• Primary Completion: 2024-12-20
• Study Completion: 2024-12-20
• Study First Submitted: 2024-12-20
• Study First Submitted QC: 2024-12-20
• Study First Posted: 2024-12-30
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-07
• Last Update Posted: 2025-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

• confirmed diagnosis of bronchial asthma (all disease severities)
• Chronic Obstructive Pulmonary Disease (COPD) with an asthma component, where the asthma component plays a clinically relevant role
• written informed consent

Exclusion Criteria

• Chronic Obstructive Pulmonary Disease (COPD) as the primary disease
• unability to perform FeNO measurement independently

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fractional Exhaled Nitric Oxide (FeNO) at rest	From enrollment to the end of rehabilitation at 3 weeks. Daily measurements at 9AM; 1PM; 5PM	Measurement of FeNo will be done with the Vivatmo Me device (by Bosch Health Care Solutions GmbH)
Fractional Exhaled Nitric Oxide (FeNO) before/after exercise	From enrollment to the end of rehabilitation at 3 weeks, FeNO measurements will be done before and after a bicycle endurance training	Measurement of FeNo will be done with the Vivatmo Me device (by Bosch Health Care Solutions GmbH)

Secondary Outcome Measures

Name	Time	Method
Asthma control	On admission and discharge from the 3-week rehabilitation programme	Assessed by Asthma Control Test (ACT)
Lung function	On admission and discharge from the 3-week rehabilitation programme	Forced expiratory flow in 1 second, will be measured by Bodyplethysmography
Eosinophils	On admission and discharge from the 3-week rehabilitation programme	Eosinophils will be collected by venous blood sample. Unit: total number of cells per ul blood and percentage
C-reactive protein	On admission and discharge from the 3-week rehabilitation programme	C-reactive protein will be collected by venous blood sample. Unit: mg/liter
Immunoglobulin E (IgE)	On admission and discharge from the 3-week rehabilitation programme	Immunoglobulin E will be collected by venous blood sample. Unit: ug/liter
6-minute walk test	On admission and discharge from the 3-week rehabilitation programme	This test will be performed according to the described standard of the American Thoracic Society and the European Respiratory Society 2014

Trial Locations

Locations (1)

Schön Klinik Berchtesgadener Land; 🇩🇪 Schonau am Konigssee, Germany