Ignite Creation Date:
2025-12-25 @ 12:57 AM
Ignite Modification Date:
2026-03-01 @ 9:54 PM
Study NCT ID:
NCT02345993
Status:
UNKNOWN
Last Update Posted:
2015-04-03
First Post:
2015-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Extra-fine Formoterol/Beclomethasone in Asthmatic Crisis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}, {'id': 'D013224', 'term': 'Status Asthmaticus'}], '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': 'D001507', 'term': 'Beclomethasone'}], 'ancestors': [{'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013258', 'term': 'Steroids, Chlorinated'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2015-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-04-01', 'studyFirstSubmitDate': '2015-01-14', 'studyFirstSubmitQcDate': '2015-01-19', 'lastUpdatePostDateStruct': {'date': '2015-04-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-01-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Length of stay in hospital', 'timeFrame': '1 week', 'description': 'in patients requiring hospitalisation, evaluate length of stay'}, {'measure': 'adverse effects', 'timeFrame': '1 week', 'description': 'adverse effects related to the drug'}], 'primaryOutcomes': [{'measure': 'Pulmonary Function', 'timeFrame': '120 minutes', 'description': 'change in Forced Expiratory Volume in 1 second (FEV1) with respect to basal'}], 'secondaryOutcomes': [{'measure': 'Need for hospitalization', 'timeFrame': '120 minutes'}, {'measure': 'Change in perception of dyspnea', 'timeFrame': '90 minutes', 'description': 'change in Borg and Transitional Dyspnea Index'}, {'measure': 'Biomarkers of inflammation', 'timeFrame': '120 minutes', 'description': 'change in C- reactive protein, TNF-alpha, eosinophils'}, {'measure': 'interleukins', 'timeFrame': '120 min', 'description': 'change in eosinophilic and non eosinophilic interleukins (IL-4, IL-5, IL-13, IL-17, IL-33)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['formoterol/beclomethasone in asthmatic crisis', 'asthmatic crisis treatment'], 'conditions': ['Asthma', 'Asthmatic Crisis']}, 'referencesModule': {'references': [{'pmid': '24041942', 'type': 'BACKGROUND', 'citation': 'Martinez FD, Vercelli D. Asthma. Lancet. 2013 Oct 19;382(9901):1360-72. doi: 10.1016/S0140-6736(13)61536-6. Epub 2013 Sep 13.'}, {'pmid': '22832835', 'type': 'BACKGROUND', 'citation': 'Garcia-Sancho C, Fernandez-Plata R, Martinez-Briseno D, Franco-Marina F, Perez-Padilla JR. [Adult asthma in Mexico City: a population-based study]. Salud Publica Mex. 2012 Jul-Aug;54(4):425-32. doi: 10.1590/s0036-36342012000400013. Spanish.'}, {'pmid': '15006973', 'type': 'BACKGROUND', 'citation': 'Rodrigo GJ, Rodrigo C, Hall JB. Acute asthma in adults: a review. Chest. 2004 Mar;125(3):1081-102. doi: 10.1378/chest.125.3.1081.'}, {'pmid': '24899370', 'type': 'BACKGROUND', 'citation': 'Lipworth B, Manoharan A, Anderson W. Unlocking the quiet zone: the small airway asthma phenotype. Lancet Respir Med. 2014 Jun;2(6):497-506. doi: 10.1016/S2213-2600(14)70103-1.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether extra fine formoterol/beclomethasona are more effective in the treatment of asthmatic crisis when added to conventional treatment compared with conventional treatment alone.', 'detailedDescription': 'Inhaled corticosteroids still the cornerstone in treatment of stable asthma, while bronchodilators and systemic steroids are in asthmatic crisis.\n\nAsthmatic exacerbations are events occurring in the natural course of the disease, require a change in actual medication and they are associated with risks of complications producing important economic costs.\n\nSome is known about non-genomic effects of inhaled corticosteroids, making possible, at least in theory, having a positive effect on treatment of a crisis. On the other hand, formoterol has been shown to have a rapid beginning of action (3 minutes), persisting its effect during 12 hours and it has been shown to be as effective as albuterol in the treatment of a crisis.\n\nThe development of extra-fine particles has allowed reaching more distal zones in the lungs producing more deposition of the drug, which as well decrease adverse effects are lesser doses of the drug are needed.\n\nAccording to that, aims of this work is to determine whether extra-fine formoterol/beclomethasona are more effective in the treatment of asthmatic crisis when added to conventional treatment compared with conventional treatment in terms of pulmonary function, symptoms, inflammation markers and rates of hospitalization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* previous asthma diagnosis by physician\n* spirometry with quality grade A, B or C\n* presenting with asthmatic crisis in emergency room\n\nExclusion Criteria:\n\n* imminent respiratory arrest\n* respiratory comorbidities (COPD, cystic fibrosis, interstitial lung disease, pneumothorax, bronchiectasis)\n* use of systemic steroids in 3 months previous\n* allergy to steroids\n* Peripheral capillary oxygen saturation (SpO2) less than 88%.'}, 'identificationModule': {'nctId': 'NCT02345993', 'briefTitle': 'Extra-fine Formoterol/Beclomethasone in Asthmatic Crisis', 'organization': {'class': 'OTHER_GOV', 'fullName': 'National Institute of Respiratory Diseases, Mexico'}, 'officialTitle': 'Extra-fine Formoterol/Beclomethasone in the Treatment of Asthmatic Crisis', 'orgStudyIdInfo': {'id': 'C40-14'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Extra fine Formoterol/Beclomethasone', 'description': 'Group receiving the drug additional to standard treatment standard treatment consisting in: Albuterol 2.5 mg via nebulizer at baseline, 0, 20, 40 minutes + Systemic steroid (methylprednisolone 60 mg) at the moment of evaluation\n\n\\+ formoterol/beclomethasone, 3 puffs administered via aerochamber at baseline (0), 20, 40 minutes', 'interventionNames': ['Drug: Extra fine Formoterol/Beclomethasone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Group receiving placebo additional to standard treatment consisting in:\n\nAlbuterol 2.5 mg via nebulizer at baseline (0), 20, 40 minutes + Systemic steroid (methylprednisolone 60 mg) at the moment of evaluation\n\n\\+ Placebo, 3 puffs administered via aerochamber at baseline (0), 20, 40 minutes'}], 'interventions': [{'name': 'Extra fine Formoterol/Beclomethasone', 'type': 'DRUG', 'otherNames': ['Innovair'], 'description': 'standard treatment consisting in: Albuterol 2.5 mg via nebulizer at baseline (0), 20, 40 minutes + Systemic steroid (methylprednisolone 60 mg) at the moment of evaluation\n\n\\+ formoterol/beclomethasone, 3 puffs administered via aerochamber at baseline (0), 20, 40, 60 minutes', 'armGroupLabels': ['Extra fine Formoterol/Beclomethasone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14080', 'city': 'Mexico City', 'state': 'Mexico City', 'country': 'Mexico', 'facility': 'National Institute of Respiratory Diseases', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}], 'overallOfficials': [{'name': 'Jose Luis Miguel, MD, MsC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Instituto Nacional de Enfermedades Respiratorias'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Respiratory Diseases, Mexico', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, MsC', 'investigatorFullName': 'Jose Luis Miguel', 'investigatorAffiliation': 'National Institute of Respiratory Diseases, Mexico'}}}}