Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2025-12-31 @ 10:35 PM
Study NCT ID:
NCT01805635
Status:
UNKNOWN
Last Update Posted:
2013-09-09
First Post:
2013-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PF and FeNO and Clinical Characteristics in Children Being Diagnosed Due to Suspicion of Allergic Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}, {'id': 'D065631', 'term': 'Rhinitis, Allergic'}, {'id': 'D003876', 'term': 'Dermatitis, Atopic'}, {'id': 'D014581', 'term': 'Urticaria'}], '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'}, {'id': 'D012220', 'term': 'Rhinitis'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}, {'id': 'D017445', 'term': 'Skin Diseases, Vascular'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'IgE specific allergen antibodies'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'completionDateStruct': {'date': '2014-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-09-06', 'studyFirstSubmitDate': '2013-02-25', 'studyFirstSubmitQcDate': '2013-03-04', 'lastUpdatePostDateStruct': {'date': '2013-09-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-03-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Fractional exhaled nitric oxide (FeNO)', 'timeFrame': '7 years', 'description': 'Fractional exhaled nitric oxide (Sievers equipment)'}, {'measure': 'Immunoglobulin E (IgE) allergen specific', 'timeFrame': '7 years', 'description': 'Immunoglobulin E (IgE) allergen specific (ELISA method)'}, {'measure': 'Treatment of asthma (drugs and dosages)', 'timeFrame': '7 years', 'description': 'Treatment of asthma (drugs and dosages last 3 months before measurement of lung function parameters and FeNO)'}], 'primaryOutcomes': [{'measure': 'Allergic disease diagnosis', 'timeFrame': '7 years', 'description': 'Allergic disease diagnosis. The diagnosis and the severity of asthma, allergic rhinitis and atopic dermatitis and other allergic diseases universally established by the doctors (allergologists) according to standard definitions of diseases in the latest guidelines'}], 'secondaryOutcomes': [{'measure': 'Lung function (LF)', 'timeFrame': '7 years', 'description': 'spirometry, whole-body pletysmography, occlusion resistance, bronchial reversibility test'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Children', 'Asthma', 'Allergic rhinitis', 'Atopic dermatitis', 'Urticaria', 'Healthy'], 'conditions': ['Asthma', 'Allergic Rhinitis', 'Atopic Dermatitis', 'Urticaria', 'Healthy']}, 'referencesModule': {'references': [{'pmid': '26628565', 'type': 'DERIVED', 'citation': 'Grzelewski T, Stelmach W, Stelmach R, Janas A, Grzelewska A, Witkowski K, Makandjou-Ola E, Majak P, Stelmach I. Spirometry-Adjusted Fraction of Exhaled Nitric Oxide Allows Asthma Diagnosis in Children, Adolescents, and Young Adults. Respir Care. 2016 Feb;61(2):162-72. doi: 10.4187/respcare.04092. Epub 2015 Dec 1.'}, {'pmid': '26216360', 'type': 'DERIVED', 'citation': 'Jerzynska J, Janas A, Galica K, Stelmach W, Woicka-Kolejwa K, Stelmach I. Total specific airway resistance vs spirometry in asthma evaluation in children in a large real-life population. Ann Allergy Asthma Immunol. 2015 Oct;115(4):272-6. doi: 10.1016/j.anai.2015.07.002. Epub 2015 Jul 26.'}, {'pmid': '24019244', 'type': 'DERIVED', 'citation': 'Grzelewski T, Witkowski K, Makandjou-Ola E, Grzelewska A, Majak P, Jerzynska J, Janas A, Stelmach R, Stelmach W, Stelmach I. Diagnostic value of lung function parameters and FeNO for asthma in schoolchildren in large, real-life population. Pediatr Pulmonol. 2014 Jul;49(7):632-40. doi: 10.1002/ppul.22888. Epub 2013 Sep 9.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to assess the influence of kind of allergic disease, allergic profile, allergen exposure, treatment method on lung function parameters, fractional exhaled nitric oxide level in children suspected and being diagnosed due to allergic diseases.', 'detailedDescription': 'The aim of this study is to assess the influence of kind of allergic disease, allergic profile, allergen exposure, treatment method on lung function parameters, fractional exhaled nitric oxide (FeNO) level in children suspected and being diagnosed due to allergic diseases.\n\nStudy will be retrospective, conducted in all children diagnosed in the years of 2005-20012 in Laboratory of lung function tests of Department of Pediatrics and Allergy, Medical University of Lodz, N. Copernicus Hospital, Lodz, Poland. The investigators will analyse 5500 male an female children 5-18 year old suspected and being diagnosed due to allergic diseases. In these children nearly 3000 FeNO measurements, 65000 spirometry measurements, 22000 whole-body plethysmography measurements and 48000 occlusion resistance measurements were performed between the years of 2005-2012.\n\nThe investigators will retrospectively evaluate following data from medical documentation of patients:\n\n1. FeNO levels.\n2. Allergic disease diagnosis.\n3. Immunoglobulin E (IgE) specific levels.\n4. Treatment (drugs and dosages).\n5. Lung function parameters (spirometry, whole-body plethysmography, occlusion resistance, bronchial reversibility test).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '5 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children with allergic diseases, healthy children.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children with allergic diseases, healthy children.\n\nExclusion Criteria:\n\n* Other serious diseases.'}, 'identificationModule': {'nctId': 'NCT01805635', 'briefTitle': 'PF and FeNO and Clinical Characteristics in Children Being Diagnosed Due to Suspicion of Allergic Diseases', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Lodz'}, 'officialTitle': 'Evaluation of the Relationship Between the Parameters of Pulmonary Function (PF) and the Concentration of Fractional Exhaled Nitric Oxide (FeNO) and Clinical Characteristics in Children Being Diagnosed Due to Suspicion of Allergic Diseases', 'orgStudyIdInfo': {'id': 'RNN/23/13/KE'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Children suspected of allergic diseases', 'description': 'Children suspected of allergic diseases No intervention', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'No intervention', 'armGroupLabels': ['Children suspected of allergic diseases']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93-513', 'city': 'Lodz', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Iwona Stelmach, MDPhDProf', 'role': 'CONTACT', 'email': 'alergol@kopernik.lodz.pl', 'phone': '48426895972'}, {'name': 'Tomasz Grzelewski, MDPhD', 'role': 'CONTACT', 'email': 'alergol@kopernik.lodz.pl', 'phone': '48426895972'}], 'facility': 'Department of Pediatrics and Allergy, Medical University of Lodz, N. Copernicus Hospital', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}], 'centralContacts': [{'name': 'Iwona Stelmach, MDPhDProf', 'role': 'CONTACT', 'email': 'alergol@kopernik.lodz.pl', 'phone': '48426895972'}, {'name': 'Tomasz Grzelewski, MD PhD', 'role': 'CONTACT', 'email': 'alergol@kopernik.lodz.pl', 'phone': '48426895972'}], 'overallOfficials': [{'name': 'Iwona Stelmach, MDPhDProf', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Pediatrics and Allergy, Medical University of Lodz, N. Copernicus Hospital, Lodz, Poland'}, {'name': 'Tomasz Grzelewski, MDPhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Pediatrics and Allergy, Medical University of Lodz, N. Copernicus Hospital, Lodz, Poland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Lodz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MDPhDProf', 'investigatorFullName': 'Iwona Stelmach', 'investigatorAffiliation': 'Medical University of Lodz'}}}}