Changes in FeNO Value During Pulmonary Rehabilitation in Patients with Asthma (Asthma FeNO)

Change in Daily FeNO During Three Weeks of Inpatient Pulmonary Rehabilitation in Patients with Asthma

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.

Study Overview

• Status: Completed
• Conditions: Asthma Bronchiale; Asthmatic Patients; Asthmatics

• Study Type: Observational
• Enrollment (Actual): 62

Contacts and Locations

Study Locations

• Germany
  • Schonau am Konigssee, Germany, 83471
    • Schön Klinik Berchtesgadener Land

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients will be recruitet at the pulmonary rehabilitation center at the Schön Klinik Berchtesgadener Land in Schönau am Königssee, Germany

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Asthmatic patients

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Schön Klinik Berchtesgadener Land
• Collaborators: Bosch Healthcare Solutions GmbH

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2021
• Primary Completion (Actual): December 20, 2024
• Study Completion (Actual): December 20, 2024

Study Registration Dates

• First Submitted: December 20, 2024
• First Submitted That Met QC Criteria: December 20, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 7, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: FeNO; Fractional Exhaled Nitric Oxide
• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Asthma
• Other Study ID Numbers: 168/20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be made available upon personal request.
• IPD Sharing Time Frame: The data will be made available upon personal request.
• IPD Sharing Access Criteria: The data will be made available upon personal request submitting a proposal that describes planned analyses.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No