Ignite Creation Date:
2025-12-24 @ 2:35 PM
Ignite Modification Date:
2025-12-26 @ 1:27 PM
Study NCT ID:
NCT01856959
Status:
COMPLETED
Last Update Posted:
2013-05-20
First Post:
2013-05-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lung Function Changes of Induced Asthma Children Treated With Inhaled MgSO4
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008278', 'term': 'Magnesium Sulfate'}, {'id': 'D000420', 'term': 'Albuterol'}], 'ancestors': [{'id': 'D017616', 'term': 'Magnesium Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D013431', 'term': 'Sulfates'}, {'id': 'D013464', 'term': 'Sulfuric Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 330}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-17', 'studyFirstSubmitDate': '2013-05-14', 'studyFirstSubmitQcDate': '2013-05-17', 'lastUpdatePostDateStruct': {'date': '2013-05-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-05-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'changes of lung function after interventions', 'timeFrame': '10 min and 20 min post-dose', 'description': 'to observe the changes of the lung function indices(FEV1、PEF) at 10 min and 20 min after inhaling magnesium sulfate, albuterol, or combination of magnesium sulfate and albuterol respectively.'}], 'secondaryOutcomes': [{'measure': 'effectiveness of nebulized magnesium sulfate alone', 'timeFrame': '10 min and 20 min post-dose', 'description': 'to observe the changes of the lung function indices(FEV1、PEF) at 10 min and 20 min after inhaling magnesium sulfate alone,and compared it with the patients who was nebulized inhalation albuterol alone.'}, {'measure': 'the number of patients with adverse events as a measure of safety and tolerability', 'timeFrame': '20 min', 'description': 'to observe if any patient appear side effects or adverse effects like nausea, vomiting, hypotension or the change of deep tendon reflexes et al.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['magnesium sulfate', 'nebulized', 'lung function'], 'conditions': ['Asthma']}, 'descriptionModule': {'briefSummary': "As a non-selective bronchodilator, magnesium sulfate (MgSO4) is effective when administered intravenously in the treatment of the patients with acute severe asthma not responding to conventional therapy (oxygen, nebulized salbutamol, and corticosteroids), which can resulted in earlier improvement in clinical signs and symptoms of asthma and PEF. However, the use of intravenous MgSO4 administered is not common in clinical practice, because it's prone to have adverse effects and side effects such as nausea, vomiting, facial flushing, hypotension, decreased tendon reflexes and so on with this treatment. The aerosolised route offers the advantage of lower dosage, a shorter time of drug being delivered to the airway smooth muscle and lower incidence of side effects when compared to the intravenous route. At present, there are only a few studies about the effects of nebulized MgSO4 in the treatment of acute asthma in children, and the conclusions are controversial."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '4 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* known cases of controlled bronchial asthma\n* ≧4 years of age\n* the result was positive after acetylcholine provocation test in follow-up visit\n\nExclusion Criteria:\n\n* had received corticosteroids (inhaled or systemic) or β2-agonists or theophyllines before the clinic day\n* had fever (axillary temperature\\>38.5℃)\n* history of chronic disease like bronchopulmonary dysplasia or cystic fibrosis\n* history of renal insufficiency and known allergy to acetylcholine, albuterol or magnesium'}, 'identificationModule': {'nctId': 'NCT01856959', 'briefTitle': 'Lung Function Changes of Induced Asthma Children Treated With Inhaled MgSO4', 'organization': {'class': 'OTHER', 'fullName': 'Chongqing Medical University'}, 'officialTitle': "Response of Asthmatic Children's Lung Function to Nebulized Magnesium Sulfate After Acetylcholine Provocation Test: a Clinical Trail", 'orgStudyIdInfo': {'id': 'MS-2013CQ'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'nebulized magnesium sulfate', 'description': 'nebulized magnesium sulfate 150mg and consisted about 5 min,which used only once', 'interventionNames': ['Drug: Magnesium Sulfate']}, {'type': 'EXPERIMENTAL', 'label': 'nebulized magnesium sulfate & albuterol', 'description': 'nebulized magnesium sulfate 150mg \\& albuterol 2.5mg and consisted about 5 min,which used only once', 'interventionNames': ['Drug: magnesium sulfate & albuterol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'nebulized albuterol', 'description': 'nebulized albuterol 2.5mg and consisted about 5 min,which used only once', 'interventionNames': ['Drug: Albuterol']}], 'interventions': [{'name': 'Magnesium Sulfate', 'type': 'DRUG', 'description': '2ml of 7.5% solution of isotonic magnesium heptahydrate, 150 mg', 'armGroupLabels': ['nebulized magnesium sulfate']}, {'name': 'magnesium sulfate & albuterol', 'type': 'DRUG', 'description': '0.5ml of albuterol mixed with 2ml of isotonic magnesium sulfate,150mg+2.5mg', 'armGroupLabels': ['nebulized magnesium sulfate & albuterol']}, {'name': 'Albuterol', 'type': 'DRUG', 'description': '0.5ml of albuterol mixed with 1.5cc of normal saline, 2.5 mg', 'armGroupLabels': ['nebulized albuterol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '400014', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'country': 'China', 'facility': "Center of Respiratory Disorders,Children's Hospital,Chongqing Medical University", 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}], 'overallOfficials': [{'name': 'Jihong Dai, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Chongqing Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chongqing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Dai Jihong', 'investigatorAffiliation': 'Chongqing Medical University'}}}}