Ignite Creation Date:
2025-12-24 @ 3:30 PM
Ignite Modification Date:
2025-12-26 @ 7:58 AM
Study NCT ID:
NCT02026492
Status:
COMPLETED
Last Update Posted:
2015-03-17
First Post:
2013-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exercise Challenge in a Cold Chamber
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001250', 'term': 'Asthma, Exercise-Induced'}], 'ancestors': [{'id': 'D001249', 'term': 'Asthma'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D000092202', 'term': 'Exercise-Induced Allergies'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 79}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-16', 'studyFirstSubmitDate': '2013-12-19', 'studyFirstSubmitQcDate': '2014-01-01', 'lastUpdatePostDateStruct': {'date': '2015-03-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Agreement of the combined exercise/cold-air challenge with the Asthma-score', 'timeFrame': '3 months', 'description': 'All children who participate will fill the asthma control test (ACT) and all adult subjects will fill the asthma control questionnaire (ACQ). The asthma-score will be compared with the severity of the exercise induced asthma measured by the maximal fall in FEV1.'}], 'primaryOutcomes': [{'measure': 'Agreement of metacholine challenge and the combined exercise/cold-air challenge', 'timeFrame': '3 months', 'description': 'Lung function will be measured prior and after methacholine- and exercise/cold-air challenges. The maximal fall in forced expiratory volume in one second (FEV1, percent predicted) after methacholine and cold air challenge will be compared by statistical correlation. For both methods the sensitivity and the specificity to predict an exercise induced asthma will be calculated by a receiver operating characteristic (ROC analysis).\n\nAll subjects receive Salbutamol to relief them from bronchial constriction at the end of the test.'}], 'secondaryOutcomes': [{'measure': 'Repeatability of the combined exercise/cold-air challenge', 'timeFrame': '3 months', 'description': 'The combined exercise/cold-air challenge will be performed twice within one week. Post challenge the FEV1 will be measured after 5, 10, 20, and 30 minutes. The maximal fall in FEV1 (percent predicted) and the area under the curve (AUC) will be compared. The agreement and the repeatability of the maximal fall in FEV1 and of the AUC will be measured by correlation and by the method of Bland and Altman.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['exercise-induced bronchoconstriction', 'exercise-induced asthma', 'cold chamber', 'exercise challenge', 'cold air challenge', 'combined exercise- and cold-air challenge', 'methacholine challenge'], 'conditions': ['Exercise-induced Asthma']}, 'referencesModule': {'references': [{'pmid': '19596563', 'type': 'BACKGROUND', 'citation': 'Schulze J, Rosewich M, Riemer C, Dressler M, Rose MA, Zielen S. Methacholine challenge--comparison of an ATS protocol to a new rapid single concentration technique. Respir Med. 2009 Dec;103(12):1898-903. doi: 10.1016/j.rmed.2009.06.007. Epub 2009 Jul 10.'}, {'pmid': '20668015', 'type': 'BACKGROUND', 'citation': 'Anderson SD. Indirect challenge tests: Airway hyperresponsiveness in asthma: its measurement and clinical significance. Chest. 2010 Aug;138(2 Suppl):25S-30S. doi: 10.1378/chest.10-0116.'}, {'pmid': '23634861', 'type': 'BACKGROUND', 'citation': 'Parsons JP, Hallstrand TS, Mastronarde JG, Kaminsky DA, Rundell KW, Hull JH, Storms WW, Weiler JM, Cheek FM, Wilson KC, Anderson SD; American Thoracic Society Subcommittee on Exercise-induced Bronchoconstriction. An official American Thoracic Society clinical practice guideline: exercise-induced bronchoconstriction. Am J Respir Crit Care Med. 2013 May 1;187(9):1016-27. doi: 10.1164/rccm.201303-0437ST.'}, {'pmid': '19161635', 'type': 'BACKGROUND', 'citation': 'Anderson SD, Charlton B, Weiler JM, Nichols S, Spector SL, Pearlman DS; A305 Study Group. Comparison of mannitol and methacholine to predict exercise-induced bronchoconstriction and a clinical diagnosis of asthma. Respir Res. 2009 Jan 23;10(1):4. doi: 10.1186/1465-9921-10-4.'}, {'pmid': '22789953', 'type': 'BACKGROUND', 'citation': 'Driessen JM, van der Palen J, van Aalderen WM, de Jongh FH, Thio BJ. Inspiratory airflow limitation after exercise challenge in cold air in asthmatic children. Respir Med. 2012 Oct;106(10):1362-8. doi: 10.1016/j.rmed.2012.06.017. Epub 2012 Jul 11.'}, {'pmid': '31097027', 'type': 'DERIVED', 'citation': 'Dressler M, Friedrich T, Lasowski N, Herrmann E, Zielen S, Schulze J. Predictors and reproducibility of exercise-induced bronchoconstriction in cold air. BMC Pulm Med. 2019 May 16;19(1):94. doi: 10.1186/s12890-019-0845-3.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the exercise-challenge in a cold chamber at 2-4°C to the gold standard the metacholine challenge in subjects showing symptoms of exercise-induced bronchoconstriction. The sensitivity and repeatability of the exercise test will be measured.', 'detailedDescription': 'Subjects suffering form exercise-induced bronchoconstriction (EIB) usually have a normal lung function testing at rest. To provoke asthma symptoms a provocation test is necessary, e.g., by bronchial methacholine testing or by a standardised exercise test on a treadmill. The correlation between methacholine and exercise test is fair, possibly because both methods measure different kinds of bronchial hyperresponsiveness. Moreover, the sensitivity and the repeatability of the exercise test is fair.\n\nThe value of the methacholine test to predict a positive exercise test will be measured. We hypothesize that the exercise test in a cold chamber, a combination of two provocation methods cold air and exercise, is more sensitive to detect EIB and that the test has a better repeatability.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '45 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Informed consent\n* Patients: Age \\>6 and \\<18 years\n* Subjects: Age \\>/=18 and \\<45 years\n* sportive, 1-2x exercise per week\n* bronchial hyperresponsiveness in the medical history\n\nExclusion Criteria:\n\n* lung function Forced vital capacity (FVC) \\<80% and Forced expiratory volume in 1 second (FEV1) \\<75%\n* chronic diseases or infections (e.g. HIV, Tbc)\n* pregnancy\n* systemic corticosteroid-treatment\n* inhalative corticosteroid therapy or leukotriene antagonists \\<14d\n* alcohol, substance or drug abuse\n* smokers\n* inability to capture extend and consequences of the study'}, 'identificationModule': {'nctId': 'NCT02026492', 'briefTitle': 'Exercise Challenge in a Cold Chamber', 'organization': {'class': 'OTHER', 'fullName': 'Johann Wolfgang Goethe University Hospital'}, 'officialTitle': 'Exercise-induced Bronchoconstriction in a Cold Chamber Compared to Methacholine Challenge', 'orgStudyIdInfo': {'id': 'KGU-208/13'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': '40 patients aged 6-18 years', 'description': 'All 40 patients with a diagnosis of asthma are recruited from the outpatients clinic of the department of Pediatric Pneumology and Allergology of the University Hospital Frankfurt. Patients undergo a methacholine challenge and two exercise challenges in a cold chamber and one exercise challenge in room temperature.', 'interventionNames': ['Other: Exercise challenge in a cold chamber', 'Other: Methacholine challenge', 'Other: Exercise challenge in room temperature']}, {'type': 'OTHER', 'label': '40 subjects aged 18-45 years', 'description': 'All subjects show bronchial hyperresponsiveness e.g. dyspnea when exercising in cold environment, in their medical history. Subjects undergo a methacholine challenge and exercise challenge in a cold chamber and one exercise challenge in room temperature.', 'interventionNames': ['Other: Exercise challenge in a cold chamber', 'Other: Methacholine challenge', 'Other: Exercise challenge in room temperature']}], 'interventions': [{'name': 'Exercise challenge in a cold chamber', 'type': 'OTHER', 'description': 'Exercise challenge is defined as running on a treadmill for 6-8 minutes on submaximal work load in a cold chamber.', 'armGroupLabels': ['40 patients aged 6-18 years', '40 subjects aged 18-45 years']}, {'name': 'Methacholine challenge', 'type': 'OTHER', 'description': 'nebulized metacholine administered at following doses: 0,01mg, 0,1mg, 0,4mg, 0,8mg und 1,6mg', 'armGroupLabels': ['40 patients aged 6-18 years', '40 subjects aged 18-45 years']}, {'name': 'Exercise challenge in room temperature', 'type': 'OTHER', 'description': 'Exercise challenge is defined as running on a treadmill for 6-8 minutes on submaximal work load in room temperature.', 'armGroupLabels': ['40 patients aged 6-18 years', '40 subjects aged 18-45 years']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60590', 'city': 'Frankfurt am Main', 'state': 'Hesse', 'country': 'Germany', 'facility': 'Goethe University Hospital Frankfurt', 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}], 'overallOfficials': [{'name': 'Johannes Schulze, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Johann Wolfgang Goethe University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johann Wolfgang Goethe University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant Pediatric Allergy and Pneumology', 'investigatorFullName': 'Johannes Schulze MD', 'investigatorAffiliation': 'Johann Wolfgang Goethe University Hospital'}}}}