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

January 7, 2025 updated by: Prof. Dr. Andreas Rembert Koczulla, Schön Klinik Berchtesgadener Land

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
62

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Asthmatic patients

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
From enrollment to the end of rehabilitation at 3 weeks. Daily measurements at 9AM; 1PM; 5PM
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)
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Asthma control
Time Frame: On admission and discharge from the 3-week rehabilitation programme
Assessed by Asthma Control Test (ACT)
On admission and discharge from the 3-week rehabilitation programme
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
On admission and discharge from the 3-week rehabilitation programme
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
On admission and discharge from the 3-week rehabilitation programme
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
On admission and discharge from the 3-week rehabilitation programme
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
On admission and discharge from the 3-week rehabilitation programme
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
On admission and discharge from the 3-week rehabilitation programme

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Schön Klinik Berchtesgadener Land

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Bosch Healthcare Solutions GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 17, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 20, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 20, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 20, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 20, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 7, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings