Changes in FeNO Value During Pulmonary Rehabilitation in Patients with Asthma

NCT06751550 | Completed

• 1 other identifier: 168/20
• Study Type: observational
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma Bronchiale; Asthmatic Patients; Asthmatics

Keywords

FeNO; Fractional Exhaled Nitric Oxide

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Asthma control

  On admission and discharge from the 3-week rehabilitation programme

• Lung function

  On admission and discharge from the 3-week rehabilitation programme

• Eosinophils

  On admission and discharge from the 3-week rehabilitation programme

• C-reactive protein

  On admission and discharge from the 3-week rehabilitation programme

• Immunoglobulin E (IgE)

  On admission and discharge from the 3-week rehabilitation programme

Study Arms (1)

Asthmatic patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Schön Klinik Berchtesgadener Land: lead
• Bosch Healthcare Solutions GmbH: collaborator

Study Sites (1)

Schön Klinik Berchtesgadener Land

Schönau am Königssee, 83471, Germany

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 20, 2024
• First Posted: December 30, 2024
• Study Start: May 17, 2021
• Primary Completion: December 20, 2024
• Study Completion: December 20, 2024
• Last Updated: January 8, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: The data will be made available upon personal request.
• Access Criteria: The data will be made available upon personal request submitting a proposal that describes planned analyses.

Locations

DE (1)