Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2025-12-25 @ 7:54 PM
Study NCT ID:
NCT01449435
Status:
COMPLETED
Last Update Posted:
2013-04-25
First Post:
2011-10-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Predictors of Asthma Exacerbations in Children
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': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-04-24', 'studyFirstSubmitDate': '2011-10-07', 'studyFirstSubmitQcDate': '2011-10-07', 'lastUpdatePostDateStruct': {'date': '2013-04-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-10-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of exacerbations', 'timeFrame': '1 year', 'description': 'An exacerbations is defined as an increased need of salbutamol (more than two puffs per week or more than five puffs per two weeks). In this case patients will be followed up at our hospital and will start an anti-inflammatory therapy, if it is necessary.'}], 'secondaryOutcomes': [{'measure': 'Predictors of exacerbations like lung function, nonspecific bronchial hyperresponsiveness to methacholine, exhaled NO, specific IgE, total IgE und ECP', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Asthma', 'children', 'predictors of exacerbation', 'Methacholine challenge', 'Pulmonary function testing'], 'conditions': ['Asthma']}, 'referencesModule': {'references': [{'pmid': '7800004', 'type': 'BACKGROUND', 'citation': 'Martinez FD, Wright AL, Taussig LM, Holberg CJ, Halonen M, Morgan WJ. Asthma and wheezing in the first six years of life. The Group Health Medical Associates. N Engl J Med. 1995 Jan 19;332(3):133-8. doi: 10.1056/NEJM199501193320301.'}, {'pmid': '9455779', 'type': 'BACKGROUND', 'citation': 'Carlsen KH. What distinguishes the asthmatic amongst the infant wheezers? Pediatr Allergy Immunol. 1997;8(10 Suppl):40-5. No abstract available.'}, {'pmid': '11029352', 'type': 'BACKGROUND', 'citation': 'Castro-Rodriguez JA, Holberg CJ, Wright AL, Martinez FD. A clinical index to define risk of asthma in young children with recurrent wheezing. Am J Respir Crit Care Med. 2000 Oct;162(4 Pt 1):1403-6. doi: 10.1164/ajrccm.162.4.9912111.'}, {'pmid': '14621083', 'type': 'BACKGROUND', 'citation': 'Kurukulaaratchy RJ, Matthews S, Holgate ST, Arshad SH. Predicting persistent disease among children who wheeze during early life. Eur Respir J. 2003 Nov;22(5):767-71. doi: 10.1183/09031936.03.00005903.'}, {'pmid': '16892787', 'type': 'BACKGROUND', 'citation': 'Kurukulaaratchy RJ, Matthews S, Arshad SH. Relationship between childhood atopy and wheeze: what mediates wheezing in atopic phenotypes? Ann Allergy Asthma Immunol. 2006 Jul;97(1):84-91. doi: 10.1016/S1081-1206(10)61375-0.'}, {'pmid': '12526066', 'type': 'BACKGROUND', 'citation': 'Thumerelle C, Deschildre A, Bouquillon C, Santos C, Sardet A, Scalbert M, Delbecque L, Debray P, Dewilde A, Turck D, Leclerc F. Role of viruses and atypical bacteria in exacerbations of asthma in hospitalized children: a prospective study in the Nord-Pas de Calais region (France). Pediatr Pulmonol. 2003 Feb;35(2):75-82. doi: 10.1002/ppul.10191.'}, {'pmid': '16109980', 'type': 'BACKGROUND', 'citation': 'Morgan WJ, Stern DA, Sherrill DL, Guerra S, Holberg CJ, Guilbert TW, Taussig LM, Wright AL, Martinez FD. Outcome of asthma and wheezing in the first 6 years of life: follow-up through adolescence. Am J Respir Crit Care Med. 2005 Nov 15;172(10):1253-8. doi: 10.1164/rccm.200504-525OC. Epub 2005 Aug 18.'}, {'pmid': '16935687', 'type': 'BACKGROUND', 'citation': 'Illi S, von Mutius E, Lau S, Niggemann B, Gruber C, Wahn U; Multicentre Allergy Study (MAS) group. Perennial allergen sensitisation early in life and chronic asthma in children: a birth cohort study. Lancet. 2006 Aug 26;368(9537):763-70. doi: 10.1016/S0140-6736(06)69286-6.'}, {'pmid': '20001651', 'type': 'BACKGROUND', 'citation': 'Zielen S, Christmann M, Kloska M, Dogan-Yildiz G, Lieb A, Rosewich M, Schubert R, Rose MA, Schulze J. Predicting short term response to anti-inflammatory therapy in young children with asthma. Curr Med Res Opin. 2010 Feb;26(2):483-92. doi: 10.1185/03007990903485148.'}, {'pmid': '17545458', 'type': 'BACKGROUND', 'citation': 'Beydon N, Davis SD, Lombardi E, Allen JL, Arets HG, Aurora P, Bisgaard H, Davis GM, Ducharme FM, Eigen H, Gappa M, Gaultier C, Gustafsson PM, Hall GL, Hantos Z, Healy MJ, Jones MH, Klug B, Lodrup Carlsen KC, McKenzie SA, Marchal F, Mayer OH, Merkus PJ, Morris MG, Oostveen E, Pillow JJ, Seddon PC, Silverman M, Sly PD, Stocks J, Tepper RS, Vilozni D, Wilson NM; American Thoracic Society/European Respiratory Society Working Group on Infant and Young Children Pulmonary Function Testing. An official American Thoracic Society/European Respiratory Society statement: pulmonary function testing in preschool children. Am J Respir Crit Care Med. 2007 Jun 15;175(12):1304-45. doi: 10.1164/rccm.200605-642ST. No abstract available.'}, {'pmid': '20734282', 'type': 'BACKGROUND', 'citation': 'Christmann M, Erffa Sv, Rosewich M, Rose MA, Schulze J, Zielen S. [The repeatability of forced expiratory manoeuvres in 4- to 6-year-old children with intermittent bronchial asthma in healthy and in exacerbated status]. Pneumologie. 2010 Dec;64(12):745-51. doi: 10.1055/s-0030-1255625. Epub 2010 Aug 23. German.'}, {'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.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether parameters of the pulmonary function tests and the bronchial hyperresponsiveness to methacholine are predictors of asthma exacerbations.', 'detailedDescription': 'Preliminary investigations from our own research group showed that lung function parameters (FEV1, the FEV1/FVC ratio and a moderate to severe hyperresponsiveness to methacholine challenge were risk factors of asthma exacerbations (OR 11.3). In the present study, these parameters will be evaluated in prospective design.\n\nOne hundred children will be included in the study. Baseline parameters will be collected in a healthy interval (visit 1), then the children will be followed up for 1 year. If the patients fulfill the criteria for an exacerbation the children will present in our department. We expect that 44% of the children have an exacerbation. All children will present at a second visit after one year (visit 2).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '4 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Outpatients of departement of Pediatric Pulmonology and Allergology.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Informed consent\n* Age \\>3 and \\<7 years\n* Diagnosis of intermittent asthma\n* In the last 24 months, at least 6 weeks of treatment with a controller medication (inhaled steroid and / or leukotriene receptor antagonist Singulair ®), or in the last 12 months, at least three episodes with an use of controller medications (inhaled steroid and / or the leukotriene receptor antagonist Singulair ®)\n* The ability to perform three reproducible spirometries\n* Examination in infection-free interval (\\> 4 weeks infection-free)\n* Minimum distance to the following asthma medications:\n* Short-acting beta 2-agonists: 8 hours\n* Ipratropium bromide: 24 hours\n* Long-acting beta 2-agonists: 24 hours\n* steroids: 4 weeks\n* leukotriene antagonist: 4 weeks\n\nExclusion Criteria:\n\n* Age older than 6 years or younger than 4\n* The inability to perform spirometry\n* Other chronic diseases or infections (eg. HIV, tuberculosis, malignancy)\n* Participation in another study'}, 'identificationModule': {'nctId': 'NCT01449435', 'briefTitle': 'Predictors of Asthma Exacerbations in Children', 'organization': {'class': 'OTHER', 'fullName': 'Johann Wolfgang Goethe University Hospital'}, 'officialTitle': 'Asthma Exacerbations in Young Children With Moderate Asthma - Prospective Evaluation of Predictors', 'orgStudyIdInfo': {'id': 'KGU-238/11'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Methacholine challenge testing', 'type': 'OTHER', 'otherNames': ['Aerosol Provocation System (Cardinal Health GmbH)'], 'description': 'Nebulized methacholine administered at the following doses: 0,1 mg/0,4 mg/0,8 mg/1,6 mg'}]}, 'contactsLocationsModule': {'locations': [{'zip': '60590', 'city': 'Frankfurt am Main', 'state': 'Hesse', 'country': 'Germany', 'facility': 'Goethe University Hospital', 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johann Wolfgang Goethe University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Cosultant Pediatric Allergy and Pulmonolgy', 'investigatorFullName': 'Johannes Schulze MD', 'investigatorAffiliation': 'Johann Wolfgang Goethe University Hospital'}}}}