Asthma BronchialeAsthma FeNONCT06751550
Changes in FeNO Value During Pulmonary Rehabilitation in Patients with Asthma
An observational study of Asthma Bronchiale and Asthmatic Patients, run by Schön Klinik Berchtesgadener Land at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma Bronchiale, Asthmatic Patients, Asthmatics
- How many people
- 62 participants
- Where
- 1 siteGermany
- Study dates
- 17 May 2021to 20 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be recruitet at the pulmonary rehabilitation center at the Schön Klinik Berchtesgadener Land in Schönau am Königssee, Germany
Who may be able to join
- 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
Who cannot join
- Chronic Obstructive Pulmonary Disease (COPD) as the primary disease
- unability to perform FeNO measurement independently
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Asthma Bronchiale, Asthmatic Patients, Asthmatics
- Keywords
- FeNO, Fractional Exhaled Nitric Oxide
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Asthmatic patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fractional Exhaled Nitric Oxide (FeNO) at rest
Measurement of FeNo will be done with the Vivatmo Me device (by Bosch Health Care Solutions GmbH)
Measured: 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)
Measured: 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
Assessed by Asthma Control Test (ACT)
Measured: On admission and discharge from the 3-week rehabilitation programme
Lung function
Forced expiratory flow in 1 second, will be measured by Bodyplethysmography
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: On admission and discharge from the 3-week rehabilitation programme
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2024
- Study start17 May 2021
- Primary completion20 Dec 2024
- Study completion20 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma BronchialeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Schön Klinik Berchtesgadener Land
- Sponsor type
- University, hospital or other
- Collaborators
- Bosch Healthcare Solutions GmbH
- Responsible party
- Principal investigator, Prof. Dr. Andreas Rembert Koczulla, Schön Klinik Berchtesgadener Land
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06751550
- Sponsor's protocol ID
- 168/20
- Acronym
- Asthma FeNO
- Status last verified
- Jan 2025
- First submitted
- 20 Dec 2024
- Last updated
- 8 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be made available upon personal request.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Change in Daily FeNO During Three Weeks of Inpatient Pulmonary Rehabilitation in Patients with Asthma
- ClinicalTrials.gov ID
- NCT06751550
- Acronym / sponsor ID
- Asthma FeNO / 168/20
- Conditions
- Asthma Bronchiale, Asthmatic Patients, Asthmatics
- Keywords
- FeNO, Fractional Exhaled Nitric Oxide
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Schön Klinik Berchtesgadener LandUniversity, hospital or other
- Collaborators
- Bosch Healthcare Solutions GmbH
- Study start
- 17 May 2021 (actual)
- Primary completion
- 20 Dec 2024 (actual)
- Study completion
- 20 Dec 2024 (actual)
- First posted
- 30 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Asthmatic patients | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruitet at the pulmonary rehabilitation center at the Schön Klinik Berchtesgadener Land in Schönau am Königssee, Germany
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Chronic Obstructive Pulmonary Disease (COPD) as the primary disease
- unability to perform FeNO measurement independently
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
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)
6 secondary outcomes
Asthma control
Time frame: On admission and discharge from the 3-week rehabilitation programme
Lung function
Time frame: On admission and discharge from the 3-week rehabilitation programme
Eosinophils
Time frame: 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
Immunoglobulin E (IgE)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2025.
- Individual participant dataSharing planned: Yes. The data will be made available upon personal request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma Bronchiale and Asthmatic Patients, run by Schön Klinik Berchtesgadener Land at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2025.