Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2025-12-28 @ 12:15 AM
Study NCT ID:
NCT04593394
Status:
COMPLETED
Last Update Posted:
2025-11-21
First Post:
2020-10-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Inducible Laryngeal Obstruction in Severe Asthma in Severe Asthma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D064706', 'term': 'Vocal Cord Dysfunction'}, {'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'id': 'D007818', 'term': 'Laryngeal Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D001982', 'term': 'Bronchial 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': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 116}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-18', 'studyFirstSubmitDate': '2020-10-13', 'studyFirstSubmitQcDate': '2020-10-13', 'lastUpdatePostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-10-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of ILO in the participants', 'timeFrame': 'One year', 'description': 'Continues during exercise(CLE)-test score at 2 or more at glottis or supraglottic level (Score range 0 minimum -3 maximum) 3 is full closure, 0 i open.'}, {'measure': 'Changes in continues during exercise (CLE-)-test score', 'timeFrame': 'One year', 'description': 'The absolute change from baseline CLE-score (Score range 0 minimum -3 maximum). 3 is full closure in larynx, 0 is open.'}], 'secondaryOutcomes': [{'measure': 'The prevalence of OSA in asthma patients with ILO.', 'timeFrame': 'One year', 'description': 'Prevalence of mild ( apnea-hypopnea index (AHI )5-15 ) moderat (AHI 15-30) and severe (AHI \\> 30 )OSA in participents with asthma and ILO'}, {'measure': 'Changes in asthma-controll score (ACT)', 'timeFrame': 'One year', 'description': 'Changes of 3 points of ACT-score are considered a clinical relevant change, score (score range minimum 5, maximum 25)'}, {'measure': 'Number of asthma-exercabations', 'timeFrame': 'One year', 'description': 'Annual asthma exacerbation rate and the precentage of patients with at least one asthma exacerbation. Asthma exacerbations are defined as worsening of asthma symptoms, and in participants on stable regimen with oral glucocorticoids, a doubling of the dose for 3 or more days or the use of systemic glucocorticoids for at least 3 days or beeing hospitalized.'}, {'measure': 'Changes in mini-Asthma quality of life (m-AQLQ)', 'timeFrame': 'One year', 'description': 'Changes of 0.5 at m-AQLQ are considered a clinical relevant change'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Inducible laryngeal dysfunction, Severe asthma,'], 'conditions': ['Asthma Chronic', 'Vocal Cord Dysfunction']}, 'referencesModule': {'references': [{'pmid': '37328176', 'type': 'DERIVED', 'citation': 'Rogde AJ, Lehmann S, Halvorsen T, Clemm HH, Roksund OD, Hufthammer KO, Kvidaland HK, Vollsaeter M, Andersen TM. Prevalence and impact of exercise-induced laryngeal obstruction in asthma: a study protocol for a cross-sectional and longitudinal study. BMJ Open. 2023 Jun 16;13(6):e071159. doi: 10.1136/bmjopen-2022-071159.'}]}, 'descriptionModule': {'briefSummary': 'The first part will be a comparative cross-sectional study to identify the frequency of ILO and other comorbidites among participants with asthma compared to a group of reference subjects without asthma, matched for age- and gender and race.\n\nThe second part will be a longitudinally observational study study following participants for one year after the cross-sectional study. The Maat-scores ILO-symptoms and asthma-outcomes longitudinally will be evaluated, .', 'detailedDescription': 'Inducible laryngeal obstruction (ILO) is characterized by inappropriate closure of the structures of the larynx causing reduced airflow. The symptoms are breathing difficulties that resemble those seen in asthmatic patients, such as dyspnea, coughing and stridor. ILO may be diagnosed by the continuous laryngoscopy during exercise test (CLE-test), where the larynx is visualized live on video as the patient runs to exhaustion on a treadmill whilst having a laryngoscope placed through the nose.\n\nThe prevalence of ILO in asthmatic patients will be assesed by preforming a CLE-test twice in all participants at baseline and again after one year. Participant will be given visual feedback and instructed in breathing techniques. Others common comorbidities will be assessed by questionnaires and clinical interview. All patients with asthma will have a respiratory polygraph recording.\n\nChanges in ILO-symptoms and asthma-symptoms and outcomes will be assessed after 1 year.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The sample size of the cohort with severe asthma will be: All patients with severe asthma followed in our clinic for severe asthma estimated to be around 80 participants, of them, we hope to recruit at least 40 to perform the CLE-test, and we plan to recruit 40 participants with mild asthma and 40 age- and gender matched control subjects without asthma', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with severe asthma (GINA 5)\n* Patients with mild-moderate well-treated asthma (GINA step 1-4)\n* Agroup of age- and gender matched control subjects without asthma also aged 18- 70.\n* The patients must have had a stable disease the last one month before performing the CLE-test\n\nExclusion Criteria:\n\n* No have underlying neurologic disease.\n* No known cancer in the lung-head-neck\n* No known vocal cord pathology.\n* No history of life-threatening asthma required hospitalization.'}, 'identificationModule': {'nctId': 'NCT04593394', 'briefTitle': 'Inducible Laryngeal Obstruction in Severe Asthma in Severe Asthma', 'organization': {'class': 'OTHER', 'fullName': 'Haukeland University Hospital'}, 'officialTitle': 'Inducible Laryngeal Obstruction in Severe Asthma', 'orgStudyIdInfo': {'id': '108266'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Severe asthma', 'description': 'Gina-guidlines treatment-step 5', 'interventionNames': ['Diagnostic Test: Continous laryngoscopy exercise test', 'Diagnostic Test: Overnight respiratory polygraphy']}, {'label': 'Mild-moderate asthma', 'description': 'Gina-guidlines treatment-step 1-4', 'interventionNames': ['Diagnostic Test: Continous laryngoscopy exercise test', 'Diagnostic Test: Overnight respiratory polygraphy']}, {'label': 'Subjects without asthma', 'description': 'Matches control-group without asthma', 'interventionNames': ['Diagnostic Test: Continous laryngoscopy exercise test', 'Diagnostic Test: Overnight respiratory polygraphy']}], 'interventions': [{'name': 'Continous laryngoscopy exercise test', 'type': 'DIAGNOSTIC_TEST', 'description': 'Participants walks on a tredmill with a a flexible naso-laryngoscope in the larynx allowing visulasion of the larynx and obstructions in the larynx at the epiglottic og glottic levels are scored', 'armGroupLabels': ['Mild-moderate asthma', 'Severe asthma', 'Subjects without asthma']}, {'name': 'Overnight respiratory polygraphy', 'type': 'DIAGNOSTIC_TEST', 'description': 'Overnight respiratory polygraphy is a continuous recording of nasal airflow, thoracic and abdominal movements, heart rate and oxygen saturation during the night used to detected sleep apnoea', 'armGroupLabels': ['Mild-moderate asthma', 'Severe asthma', 'Subjects without asthma']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5021', 'city': 'Bergen', 'country': 'Norway', 'facility': 'Haukeland University Hospital', 'geoPoint': {'lat': 60.39299, 'lon': 5.32415}}], 'overallOfficials': [{'name': 'Sverre Lehmann, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Haukeland University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Haukeland University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}