Ignite Creation Date:
2025-12-24 @ 5:07 PM
Ignite Modification Date:
2025-12-28 @ 6:42 AM
Study NCT ID:
NCT01012050
Status:
COMPLETED
Last Update Posted:
2009-11-11
First Post:
2009-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Radioaerosol Pulmonary Deposition During Asthma Exacerbation Through Noninvasive Ventilation
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': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-11', 'completionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-11-10', 'studyFirstSubmitDate': '2009-04-22', 'studyFirstSubmitQcDate': '2009-11-10', 'lastUpdatePostDateStruct': {'date': '2009-11-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-11-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiopulmonary characteristics', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Radioaerosol pulmonary index, radioaerosol penetration index and pulmonary clearance.', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Asthma', 'status asthmatics'], 'conditions': ['Asthma']}, 'referencesModule': {'references': [{'pmid': '12684289', 'type': 'BACKGROUND', 'citation': 'Soroksky A, Stav D, Shpirer I. A pilot prospective, randomized, placebo-controlled trial of bilevel positive airway pressure in acute asthmatic attack. Chest. 2003 Apr;123(4):1018-25. doi: 10.1378/chest.123.4.1018.'}, {'pmid': '16139491', 'type': 'BACKGROUND', 'citation': 'Franca EE, Dornelas de Andrade AF, Cabral G, Almeida Filho P, Silva KC, Galindo Filho VC, Marinho PE, Lemos A, Parreira VF. Nebulization associated with bi-level noninvasive ventilation: analysis of pulmonary radioaerosol deposition. Respir Med. 2006 Apr;100(4):721-8. doi: 10.1016/j.rmed.2005.07.012. Epub 2005 Aug 31.'}, {'pmid': '18344635', 'type': 'BACKGROUND', 'citation': 'Soma T, Hino M, Kida K, Kudoh S. A prospective and randomized study for improvement of acute asthma by non-invasive positive pressure ventilation (NPPV). Intern Med. 2008;47(6):493-501. doi: 10.2169/internalmedicine.47.0429. Epub 2008 Mar 17.'}, {'pmid': '22781558', 'type': 'DERIVED', 'citation': 'Galindo-Filho VC, Brandao DC, Ferreira Rde C, Menezes MJ, Almeida-Filho P, Parreira VF, Silva TN, Rodrigues-Machado Mda G, Dean E, Dornelas de Andrade A. Noninvasive ventilation coupled with nebulization during asthma crises: a randomized controlled trial. Respir Care. 2013 Feb;58(2):241-9. doi: 10.4187/respcare.01371.'}], 'seeAlsoLinks': [{'url': 'http://www.nlm.nih.gov/medlineplus/asthma.html', 'label': 'Related Info'}, {'url': 'http://www.asthma.org.uk/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Despite the physiologic and clinical effects provided by coupling nebulization with noninvasive ventilation in asthma exacerbation, there are few and controversial studies reported in the literature.', 'detailedDescription': 'Reduced work of breathing, increased oxygenation and increased in expiratory peak flow (EPF) and forced expiratory volume in the first second (FEV1) are benefits of noninvasive ventilation (NV) in the treatment of asthma. Despite these clinical improvements attributed to NV during asthma exacerbations and the well-established effects of nebulization, there are few studies in the literature coupling both therapeutic resources.\n\nIn addition to this, no studies on scintigraphic analysis of radioaerosol deposition coupled with NV in asthmatics have published. A previous study was published by our group, but involved healthy subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of moderate to severe asthma (FEV1 \\< 60 % of predicted values)\n* Breathing rate \\> 25 bpm\n* History of asthma for at least 1 year\n* Duration of current asthma attack of \\< 7 days\n* Reversibility of FEV1 of at least ≤ 10% after the administration of bronchodilator drugs\n\nExclusion Criteria:\n\n* Current smoker\n* Presence of cardiopulmonary disease (COPD, pneumonia, heart failure, myocardial infarction, pneumothorax)\n* Hyperthermia\n* Indication of intubation and invasive mechanical ventilation;\n* Hemodynamic instability (heart rate \\> 150 bpm and systolic blood pressure \\< 90 mmHg)\n* Cardiac arrhythmia\n* Changes in consciousness\n* Pregnancy\n* Contraindications to use NV'}, 'identificationModule': {'nctId': 'NCT01012050', 'acronym': 'NV', 'briefTitle': 'Radioaerosol Pulmonary Deposition During Asthma Exacerbation Through Noninvasive Ventilation', 'organization': {'class': 'OTHER', 'fullName': 'Universidade Federal de Pernambuco'}, 'officialTitle': 'Analysing the Effects of Coupling Nebulization to Noninvasive Ventilation Through Pulmonary Scintigraphy on the Radioaerosol Deposition During Asthma Exacerbation', 'orgStudyIdInfo': {'id': 'VNI1972NEB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NV Group', 'description': 'Performed nebulization coupled with noninvasive ventilation', 'interventionNames': ['Device: NV']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'NEB group', 'description': 'Performed nebulization alone.', 'interventionNames': ['Other: NEB group']}], 'interventions': [{'name': 'NV', 'type': 'DEVICE', 'otherNames': ['Interventional Group'], 'description': 'Noninvasive ventilation coupled with nebulization(Nebulization containing salbutamol (2.5mg) and ipratropium bromide (0.25mg)plus oxygen flow in 7Lpm)', 'armGroupLabels': ['NV Group']}, {'name': 'NEB group', 'type': 'OTHER', 'otherNames': ['Control group'], 'description': 'Nebulization containing salbutamol (2.5mg) and ipratropium bromide (0.25mg)plus oxygen flow in 7Lpm', 'armGroupLabels': ['NEB group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Recife', 'state': 'Pernambuco', 'country': 'Brazil', 'facility': 'Valdecir Castor Galindo Filho', 'geoPoint': {'lat': -8.05389, 'lon': -34.88111}}], 'overallOfficials': [{'name': 'Valdecir C Galindo', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidade Federal de Pernambuco'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade Federal de Pernambuco', 'class': 'OTHER'}, 'collaborators': [{'name': 'Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.', 'class': 'OTHER_GOV'}], 'responsibleParty': {'oldNameTitle': 'Valdecir Castor Galindo Filho', 'oldOrganization': 'Universidade Federal de Pernambuco'}}}}