Ignite Creation Date:
2025-12-24 @ 9:41 PM
Ignite Modification Date:
2025-12-25 @ 7:23 PM
Study NCT ID:
NCT01286532
Status:
COMPLETED
Last Update Posted:
2013-02-01
First Post:
2011-01-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Asthma 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': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 283}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-31', 'studyFirstSubmitDate': '2011-01-28', 'studyFirstSubmitQcDate': '2011-01-28', 'lastUpdatePostDateStruct': {'date': '2013-02-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-01-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To compare percentage (%) of responding children by the end of 6-month observation. Responders are defined as children with adequate control of symptoms at the end of 6 months observation (Childhood Asthma Control Test (CACT) score > 19)', 'timeFrame': '3 visits for 6 month'}], 'secondaryOutcomes': [{'measure': 'To determine mean number of severe bronchial asthma exacerbations within 6 months', 'timeFrame': '3 visits for 6 month'}, {'measure': 'To determine mean duration of bronchial asthma exacerbations including hospital admissions, daytime hospital treatment and any cases of oral administration of glucocorticoids > 3 consecutive days during the observation period', 'timeFrame': '3 visits for 6 month'}, {'measure': 'To determine mean requirement in short-acting β2-agonists and/or rapidly released methylxanthines per week during the period of observation', 'timeFrame': '3 visits for 6 month'}, {'measure': 'To determine the independent factors associated with failure of treatment of asthma (demographic and baseline patient data, site)', 'timeFrame': '3 visits for 6 month'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Asthma, Asthma in Children'], 'conditions': ['Asthma']}, 'descriptionModule': {'briefSummary': 'This is a six-month non-interventional prospective study of various controller therapies in children with asthma in outpatient clinical practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'minimumAge': '5 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children (male or female) aged 5 to 11 years inclusive on step 3 asthma combination therapy with ICS and LABA who have completed at least one valid CACT assessment after the study entry', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Child (male or female) aged 5 to 11 years inclusive\n* Provision of Subject Informed Consent Form for anonymous data collection and their subsequent use (must be signed by any of the parents)\n* The child must be included in an out-patient observation program at a medical institution for established bronchial asthma diagnosis for at least 1 year prior to enrolment and diagnosed with moderate to severe bronchial asthma at the time of enrolment\n* The child must have at least one documented bronchial asthma exacerbation in previous 1 year (including hospital admissions for bronchial asthma exacerbations, any cases of daytime hospital treatment without overnight stays and any cases of oral administration of glucocorticoids on an out-patient basis for \\> 3 consecutive days)\n* Out-patient receiving step 3 controller treatments with fixed dose combinations of ICSs and LABA or treatment with separate administration of glucocorticoids and LABA in stable doses with adequate control of bronchial asthma symptoms\n* The patient administered with short-acting β2 agonists (inhalational) or rapidly released methylxanthines (oral) in the doses approved for the respective age as a rescue on-demand therapies during the preceding month\n\nExclusion Criteria:\n\n* Cystic fibrosis, α1-antitrypsin deficiency or congenital abnormalities of lung development\n* Severe comorbidities affecting the patient's overall performance\n* In the physician's opinion, the patient is not able to comply with the protocol requirements\n* Expected specific hyposensibilization within next 6 months\n* Expected treatment at health resort facilities within next 6 months\n* Other reasons that in the physician's opinion will prevent reliable assessments of the study treatment efficacy"}, 'identificationModule': {'nctId': 'NCT01286532', 'briefTitle': 'Asthma in Children', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Six-month Non-interventional Prospective Study of Various Controller Therapies for Moderate Persistent and Severe Persistent Asthma in Children in Real Life Outpatient Clinical Practice', 'orgStudyIdInfo': {'id': 'NIS-RRU-XXX-2010/1'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Children (male or female) aged 5 to 11 years inclusive on step 3 asthma combination therapy with ICS(inhalation glucocorticosteroids) and LABA ( long-acting b2-agonist) who have completed at least one valid CACT assessment after the study entry'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chelyabinsk', 'country': 'Russia', 'facility': 'Research site', 'geoPoint': {'lat': 55.1611, 'lon': 61.42877}}, {'city': 'Moscow', 'country': 'Russia', 'facility': 'Research site', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'N.Novgorod', 'country': 'Russia', 'facility': 'Research site'}, {'city': 'Novosibirsk', 'country': 'Russia', 'facility': 'Research site', 'geoPoint': {'lat': 55.02259, 'lon': 82.93175}}, {'city': 'Rostov-on-Don', 'country': 'Russia', 'facility': 'Research site', 'geoPoint': {'lat': 47.21997, 'lon': 39.70769}}, {'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Research site', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'city': 'Samara', 'country': 'Russia', 'facility': 'Research site', 'geoPoint': {'lat': 53.20767, 'lon': 50.13553}}, {'city': 'Tula', 'country': 'Russia', 'facility': 'Research site', 'geoPoint': {'lat': 54.19609, 'lon': 37.61822}}, {'city': "Tver'", 'country': 'Russia', 'facility': 'Research site', 'geoPoint': {'lat': 56.85836, 'lon': 35.90057}}, {'city': 'Ufa', 'country': 'Russia', 'facility': 'Research site', 'geoPoint': {'lat': 54.74306, 'lon': 55.96779}}, {'city': 'Volgograd', 'country': 'Russia', 'facility': 'Research site', 'geoPoint': {'lat': 48.71378, 'lon': 44.4976}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}