Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2025-12-24 @ 5:25 PM
Study NCT ID:
NCT06751550
Status:
COMPLETED
Last Update Posted:
2025-01-08
First Post:
2024-12-20
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Changes in FeNO Value During Pulmonary Rehabilitation in Patients with Asthma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-12-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-07', 'studyFirstSubmitDate': '2024-12-20', 'studyFirstSubmitQcDate': '2024-12-20', 'lastUpdatePostDateStruct': {'date': '2025-01-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fractional Exhaled Nitric Oxide (FeNO) at rest', 'timeFrame': 'From enrollment to the end of rehabilitation at 3 weeks. Daily measurements at 9AM; 1PM; 5PM', 'description': 'Measurement of FeNo will be done with the Vivatmo Me device (by Bosch Health Care Solutions GmbH)'}, {'measure': 'Fractional Exhaled Nitric Oxide (FeNO) before/after exercise', 'timeFrame': 'From enrollment to the end of rehabilitation at 3 weeks, FeNO measurements will be done before and after a bicycle endurance training', 'description': 'Measurement of FeNo will be done with the Vivatmo Me device (by Bosch Health Care Solutions GmbH)'}], 'secondaryOutcomes': [{'measure': 'Asthma control', 'timeFrame': 'On admission and discharge from the 3-week rehabilitation programme', 'description': 'Assessed by Asthma Control Test (ACT)'}, {'measure': 'Lung function', 'timeFrame': 'On admission and discharge from the 3-week rehabilitation programme', 'description': 'Forced expiratory flow in 1 second, will be measured by Bodyplethysmography'}, {'measure': 'Eosinophils', 'timeFrame': 'On admission and discharge from the 3-week rehabilitation programme', 'description': 'Eosinophils will be collected by venous blood sample. Unit: total number of cells per ul blood and percentage'}, {'measure': 'C-reactive protein', 'timeFrame': 'On admission and discharge from the 3-week rehabilitation programme', 'description': 'C-reactive protein will be collected by venous blood sample. Unit: mg/liter'}, {'measure': 'Immunoglobulin E (IgE)', 'timeFrame': 'On admission and discharge from the 3-week rehabilitation programme', 'description': 'Immunoglobulin E will be collected by venous blood sample. Unit: ug/liter'}, {'measure': '6-minute walk test', 'timeFrame': 'On admission and discharge from the 3-week rehabilitation programme', 'description': 'This test will be performed according to the described standard of the American Thoracic Society and the European Respiratory Society 2014'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['FeNO', 'Fractional Exhaled Nitric Oxide'], 'conditions': ['Asthma Bronchiale', 'Asthmatic Patients', 'Asthmatics']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients will be recruitet at the pulmonary rehabilitation center at the Schön Klinik Berchtesgadener Land in Schönau am Königssee, Germany', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* confirmed diagnosis of bronchial asthma (all disease severities)\n* Chronic Obstructive Pulmonary Disease (COPD) with an asthma component, where the asthma component plays a clinically relevant role\n* written informed consent\n\nExclusion Criteria:\n\n* Chronic Obstructive Pulmonary Disease (COPD) as the primary disease\n* unability to perform FeNO measurement independently'}, 'identificationModule': {'nctId': 'NCT06751550', 'acronym': 'Asthma FeNO', 'briefTitle': 'Changes in FeNO Value During Pulmonary Rehabilitation in Patients with Asthma', 'organization': {'class': 'OTHER', 'fullName': 'Schön Klinik Berchtesgadener Land'}, 'officialTitle': 'Change in Daily FeNO During Three Weeks of Inpatient Pulmonary Rehabilitation in Patients with Asthma', 'orgStudyIdInfo': {'id': '168/20'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Asthmatic patients'}]}, 'contactsLocationsModule': {'locations': [{'zip': '83471', 'city': 'Schönau am Königssee', 'country': 'Germany', 'facility': 'Schön Klinik Berchtesgadener Land', 'geoPoint': {'lat': 47.60055, 'lon': 12.98704}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': 'The data will be made available upon personal request.', 'ipdSharing': 'YES', 'description': 'The data will be made available upon personal request.', 'accessCriteria': 'The data will be made available upon personal request submitting a proposal that describes planned analyses.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Schön Klinik Berchtesgadener Land', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bosch Healthcare Solutions GmbH', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Prof. Dr. Andreas Rembert Koczulla', 'investigatorAffiliation': 'Schön Klinik Berchtesgadener Land'}}}}