Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2025-12-25 @ 11:57 PM
Study NCT ID:
NCT04918394
Status:
COMPLETED
Last Update Posted:
2022-04-06
First Post:
2021-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mold Exposure and Impact on Asthma Control in French Asthmatic 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': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 451}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2021-08-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-28', 'studyFirstSubmitDate': '2021-06-02', 'studyFirstSubmitQcDate': '2021-06-02', 'lastUpdatePostDateStruct': {'date': '2022-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Asthma control according to GINA guidelines', 'timeFrame': 'At the time of inclusion', 'description': 'The Global Initiative for Asthma (GINA)guidelines:\n\nWell controlled Partly controlled Uncontrolled'}], 'secondaryOutcomes': [{'measure': 'Asthma control according to Asthma Control Test (ACT) score in children aged 12 years and older: Controlled if ACT ≥ 20', 'timeFrame': 'At the time of inclusion', 'description': 'Asthma Control Test: Each question is assigned a score between 1 and 5 (the score for the first answer proposal is 1, the second is 2, and so on). The score of the 5 questions is added up to a total score that can vary between 5 and 25. The higher the total score, the better the asthma is controlled.'}, {'measure': 'Asthma control according to pACT score in children aged 1 to 11 years old: Controlled if ACT ≥ 20', 'timeFrame': 'At the time of inclusion'}, {'measure': 'Asthma treatment step according to GINA guidelines: Step 1 to step 4 in children aged < 6 years Step 1 to step 5 in children aged ≥ 6 years', 'timeFrame': 'At the time of inclusion'}, {'measure': 'Inhaled corticosteroid doses in µg/day of fluticasone', 'timeFrame': 'At the time of inclusion'}, {'measure': 'Acute asthma events in the past 12 months', 'timeFrame': 'At the time of inclusion', 'description': 'Acute asthma events: emergency room visits, hospitalization, general corticosteroid course'}, {'measure': 'Exposure to other indoor pollutants: cigarette smoke (declarative smoking by at least one of the parents)', 'timeFrame': 'At the time of inclusion'}, {'measure': 'Exposure to indoor allergens: declarative exposure to animal danders', 'timeFrame': 'At the time of inclusion'}, {'measure': 'Exposure to indoor allergens: declarative exposure to house dust mite (carpet, mattress)', 'timeFrame': 'At the time of inclusion'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Asthma', 'Children', 'Mold', 'Moisture', 'Asthma Control'], 'conditions': ['Asthma in Children']}, 'referencesModule': {'references': [{'pmid': '40130077', 'type': 'DERIVED', 'citation': 'Sauvere M, Lejeune S, Chagnon F, Drumez E, Cisterne C, Mordacq C, Thumerelle C, Scalbert M, Le Mee A, Amani M, El Mourad S, Enchery S, Pouessel G, Roussel J, Dartus M, Behal H, Deschildre A. Home exposure to moisture and mold is associated with poorer asthma control in children: CHAMPIASTHMA study. J Allergy Clin Immunol Glob. 2025 Jan 17;4(2):100415. doi: 10.1016/j.jacig.2025.100415. eCollection 2025 May.'}]}, 'descriptionModule': {'briefSummary': 'Observational, multicenter, study conducted in 12 hospitals in the Nord and Pas-De-Calais departments. The aim of this study is to describe the relationship between reported exposure to molds and asthma control in a pediatric population.\n\nEach patient followed by a specialized asthma pediatrician in one of the study center will be proposed to participate in the study.\n\nChildren aged 1 to \\< 18 years, with asthma diagnosis, based on the assessment of a specialized physician after a follow-up of at least 6 months Inclusion, non-inclusion and exclusion criteria will be verified by the investigators. The questionnaires will be completed during the consultation, collected by the physician in charge of the consultation and sent to the principal investigator for data entry.\n\nInclusion will take place over a period of 12 consecutive months from the date of obtaining regulatory approval.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Year', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children follow-up by a specialized asthma pediatrician in secondary (general hospital) and tertiary care (Lille university hospital) centers.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children aged 1 to \\< 18 years, with asthma diagnosis, based on the assessment of a specialized physician after a follow-up of at least 6 months, Follow-up in one of the study center in Nord and Pas de Calais departments (Lille, Lens, Tourcoing, Valenciennes, Arras, Roubaix, Seclin, Armentières, Calais, Boulogne/mer, Dunkerque, GHICL-Saint Vincent) over an inclusion period of 12 months\n\nExclusion Criteria:\n\n* Children living ≤ 50% of the weekly time in their primary home (e.g., shared custody)\n* Children whose living arrangement characteristics are difficult to analyze (e.g., child accompanied by grandparents or by the parent without primary custody)\n* Children whose residence has recently changed, making it impossible to assess the impact of the living arrangement over the past year\n* Children living outside of the Nord and Pas-de-Calais departments\n* Children whose parents are unable to complete the questionnaire'}, 'identificationModule': {'nctId': 'NCT04918394', 'acronym': 'CHAMPIASTHMA', 'briefTitle': 'Mold Exposure and Impact on Asthma Control in French Asthmatic Children', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Lille'}, 'officialTitle': 'Assessment of Mold Exposure in Asthmatic Children Follow-up in Nord and Pas-De-Calais Departments, France, and Impact on Asthma Control', 'orgStudyIdInfo': {'id': '2019_49'}, 'secondaryIdInfos': [{'id': '2019-A03310-57', 'type': 'OTHER', 'domain': 'ID-RCB number,ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Asthma patients unexposed to mold / moisture', 'description': "No mold / moisture exposure is defined by a negative response to all of the 5 following questions, asked in the form of a parent-completed declarative questionnaire regarding the child's primary living home.", 'interventionNames': ['Other: Questionnaire of Mold / moisture exposure']}, {'label': 'Asthma patients exposed to mold / moisture', 'description': "Mold / moisture exposure is defined by a positive response to at least one of the 5 following questions, asked in the form of a parent-completed declarative questionnaire regarding the child's primary living home.", 'interventionNames': ['Other: Questionnaire of Mold / moisture exposure']}], 'interventions': [{'name': 'Questionnaire of Mold / moisture exposure', 'type': 'OTHER', 'description': "Mold / moisture exposure is assessed by the 5 following questions, whose positive response has been associated with the actual presence of mold in the household (according to data from the literature data), asked in the form of a parent-completed declarative questionnaire regarding the child's primary living home:\n\n* Presence of visible mold\n* Impression of dampness\n* Apparent dampness\n* Existence of recent water damage in the last year\n* Presence of a moldy odor", 'armGroupLabels': ['Asthma patients exposed to mold / moisture', 'Asthma patients unexposed to mold / moisture']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Armentières', 'country': 'France', 'facility': 'Ch Armentieres', 'geoPoint': {'lat': 50.68568, 'lon': 2.88214}}, {'zip': '62321', 'city': 'Boulogne-sur-Mer', 'country': 'France', 'facility': 'Ch Boulogne-Sur-Me', 'geoPoint': {'lat': 50.72485, 'lon': 1.61373}}, {'city': 'Calais', 'country': 'France', 'facility': 'Ch Calais', 'geoPoint': {'lat': 50.95194, 'lon': 1.85635}}, {'zip': '59385', 'city': 'Dunkirk', 'country': 'France', 'facility': 'CH Dunkerque', 'geoPoint': {'lat': 51.0344, 'lon': 2.37681}}, {'city': 'Lens', 'country': 'France', 'facility': 'Centre Hospitalier de Lens', 'geoPoint': {'lat': 50.43302, 'lon': 2.82791}}, {'zip': '59037', 'city': 'Lille', 'country': 'France', 'facility': 'Hop Jeanne de Flandre Chu Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'city': 'Lille', 'country': 'France', 'facility': 'Centre Hospitalier St Vincent', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'city': 'Roubaix', 'country': 'France', 'facility': 'Centre hospitalier de Roubaix', 'geoPoint': {'lat': 50.69421, 'lon': 3.17456}}, {'city': 'Seclin', 'country': 'France', 'facility': 'Centre Hospitalier de Seclin', 'geoPoint': {'lat': 50.54873, 'lon': 3.02731}}, {'city': 'Valenciennes', 'country': 'France', 'facility': 'Centre Hospitalier,', 'geoPoint': {'lat': 50.35909, 'lon': 3.52506}}], 'overallOfficials': [{'name': 'Antoine DESCHILDRE, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Lille'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Lille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}