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Completed

NCT Number: NCT06751550

Changes in FeNO Value During 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.

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Key information

Conditions

Asthma Bronchiale Asthma Asthmatic Patients Asthmatics Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Schön Klinik Berchtesgadener Land

Schönau am Königssee, 83471, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Fractional Exhaled Nitric Oxide (FeNO) at rest

    Time frame: 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)

  2. Fractional Exhaled Nitric Oxide (FeNO) before/after exercise

    Time frame: 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 outcomes

  1. Asthma control

    Time frame: On admission and discharge from the 3-week rehabilitation programme

    Assessed by Asthma Control Test (ACT)

  2. Lung function

    Time frame: On admission and discharge from the 3-week rehabilitation programme

    Forced expiratory flow in 1 second, will be measured by Bodyplethysmography

  3. Eosinophils

    Time frame: 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

  4. C-reactive protein

    Time frame: On admission and discharge from the 3-week rehabilitation programme

    C-reactive protein will be collected by venous blood sample. Unit: mg/liter

  5. Immunoglobulin E (IgE)

    Time frame: On admission and discharge from the 3-week rehabilitation programme

    Immunoglobulin E will be collected by venous blood sample. Unit: ug/liter

  6. 6-minute walk test

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Schön Klinik Berchtesgadener Land

Other

Collaborators

  • Bosch Healthcare Solutions GmbH

Registry information

Official study title

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

Acronym: Asthma FeNO

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Dec 30, 2024
Registry last updated
Jan 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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