Ignite Creation Date:
2025-12-25 @ 4:09 AM
Ignite Modification Date:
2025-12-26 @ 3:06 AM
Study NCT ID:
NCT04016220
Status:
UNKNOWN
Last Update Posted:
2019-07-11
First Post:
2019-05-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Nebulized Budesonide Combined With Systemic Corticosteroid in Acute Severe Asthma
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': 'D019819', 'term': 'Budesonide'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D011282', 'term': 'Pregnenediones'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER'], 'maskingDescription': 'senior ED and patient do not know the randomization group'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-05-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2020-05-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-07-09', 'studyFirstSubmitDate': '2019-05-29', 'studyFirstSubmitQcDate': '2019-07-09', 'lastUpdatePostDateStruct': {'date': '2019-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'admission rate', 'timeFrame': '3 hours', 'description': 'The decision to discharge or admit a patient was made at the end of the protocol (180 minutes)'}], 'secondaryOutcomes': [{'measure': 'Peak expiratory flow', 'timeFrame': '3 hours', 'description': 'Peak expiratory flow (L/min) was measured in each patient immediately before starting the treatment and at 30 minute intervals for 3 hours after presentation.'}, {'measure': 'respiratory rate was measured in each patient immediately before starting the treatment and at 30 minute intervals for 3 hours after presentation.', 'timeFrame': '3 hours', 'description': 'respiratory rate'}, {'measure': 'dyspnea scale', 'timeFrame': '3 hours', 'description': "Dyspnea was assessed by the patient's own sensation of respiratory difficulty with a value assigned on a scale of 0 to 3, in which 0 denoted absent, 1 mild, 2 moderate, and 3 severe. was measured in each patient immediately before starting the treatment and at 30 minute intervals for 3 hours after presentation:"}, {'measure': 'Hear rate', 'timeFrame': '3 hours', 'description': 'Heart rate was measured in each patient immediately before starting the treatment and at 30 minute intervals for 3 hours after presentation.'}, {'measure': 'tremor', 'timeFrame': '3 hours', 'description': 'incidence of tremor'}, {'measure': 'dry mouth', 'timeFrame': '3 hours', 'description': 'incidence of dry mouth'}, {'measure': 'palpitation', 'timeFrame': '3 hours', 'description': 'incidence of palpitation'}, {'measure': 'headache', 'timeFrame': '3 hours', 'description': 'incidence of headache'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['asthma', 'budesonide', 'nebulized', 'adult'], 'conditions': ['Acute Asthma']}, 'referencesModule': {'references': [{'pmid': '9043535', 'type': 'BACKGROUND', 'citation': 'Guttman A, Afilalo M, Colacone A, Kreisman H, Dankoff J. The effects of combined intravenous and inhaled steroids (beclomethasone dipropionate) for the emergency treatment of acute asthma. The Asthma ED Study Group. Acad Emerg Med. 1997 Feb;4(2):100-6. doi: 10.1111/j.1553-2712.1997.tb03714.x.'}, {'pmid': '16433920', 'type': 'BACKGROUND', 'citation': 'Bateman ED, Fairall L, Lombardi DM, English R. Budesonide/formoterol and formoterol provide similar rapid relief in patients with acute asthma showing refractoriness to salbutamol. Respir Res. 2006 Jan 24;7(1):13. doi: 10.1186/1465-9921-7-13.'}, {'pmid': '15764724', 'type': 'RESULT', 'citation': 'Rodrigo GJ. Comparison of inhaled fluticasone with intravenous hydrocortisone in the treatment of adult acute asthma. Am J Respir Crit Care Med. 2005 Jun 1;171(11):1231-6. doi: 10.1164/rccm.200410-1415OC. Epub 2005 Mar 11.'}, {'pmid': '35870902', 'type': 'DERIVED', 'citation': 'Marghli S, Bouhamed C, Sghaier A, Chebbi N, Dlala I, Bettout S, Belkacem A, Kbaier S, Jerbi N, Bellou A. Nebulized budesonide combined with systemic corticosteroid vs systemic corticosteroid alone in acute severe asthma managed in the emergency department: a randomized controlled trial. BMC Emerg Med. 2022 Jul 23;22(1):134. doi: 10.1186/s12873-022-00691-9.'}]}, 'descriptionModule': {'briefSummary': 'Our study is a prospective double-blind randomized study performed in the Emergency Department (ED). The objective of our study was to demonstrate the additive effect of high and repeated doses of inhaled budesonide combined with the standard treatment of acute asthma in adult managed in the ED', 'detailedDescription': "Patients were included in a double-blind, randomized into one of two groups. The experimental group received a first nebulization of 5 mg of terbutaline (Bricanyl®, AstraZeneca : solution of 5mg/ 2 ml ) in association with 0.5 mg of ipratropium bromide (Ipratropium®, AGUETTANT, solution of 0.5 mg/ 2 ml) and 0.5 mg of budesonide (Pulmicort®, AstraZeneca, solution of 0.5 mg/2 ml) followed by repetitive nebulization of 5 mg of terbutaline with 0.5 mg of budesonide at 20, 40, 60 and 120 min. The control group received a first nebulization of 5 mg of terbutaline in association with 0.5 mg of ipratropium bromide and 2 ml of normal saline followed by a repetitive nebulization of 5 mg de terbutaline with 2 ml of normal saline at 20, 40, 60 and 120 min (Figure 1). The placebo and the budesonide were prepared by the pharmacist. All patients received hydrocortisone hemisuccinate (100 mg i.v.) and O2 (7 l/ min) via a nebulizer (Mini nebulizer 40-115510; Peters, France).\n\nMeasure The following parameters were measured in each patient immediately before starting the treatment and at 30 minute intervals for 3 hours after presentation: peak expiratory flow (PEF), respiratory rate (RR), heart rate (HR), dyspnea scale, systolic and diastolic blood pressure. PEF was measured with peak flow meter (mini-Wright; Clement Clarke; Harlow, UK). The highest of three values was recorded. HR was measured from continuous monitor. Dyspnea was assessed by the patient's own sensation of respiratory difficulty with a value assigned on a scale of 0 to 3, in which 0 denoted absent, 1 mild, 2 moderate, and 3 severe. At the end of the treatment, the patient was asked to indicate the presence or absence of each of five symptoms: palpitations, tremor, anxiety, headache, and dry mouth. Also, an interviewer determined the duration of symptoms before presentation, which specifically included how long the patient had been wheezing and shorter of breath than usual; a decline in the PEF, if available, was considered. The occurrence of a worsening of ventilator status requiring mechanical ventilation led to interrupt the study protocol. The decision to discharge or admit a patient was made at the end of the protocol (180 minutes) by a senior ED staff without knowledge of previous patient group allocation. Although some patients met discharge criteria during the study, none were discharged until the end of the protocol. Patients were discharged from the ED according to the following criteria: if accessory-muscle use disappeared, if wheezing was judged minimal to completely resolved, if they were free of dyspnea, and if PEF was more than 60% of predicted value. Physicians prescribed oral prednisone (40 mg for 7 days) for all discharged patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* acute asthma\n* peak expiratory flow (PEF) rate less than 50% of predicted value\n* one or more of the following features were present: accessory muscle activity, a heart rate greater than 110 beats/minute, a respiratory rate greater than 25 breaths/minute, a limited ability to speak\n* written informed consent obtained\n\nExclusion Criteria:\n\n* temperature higher than 38°C\n* history of cardiac, hepatic, renal, or other medical disease\n* pregnant'}, 'identificationModule': {'nctId': 'NCT04016220', 'briefTitle': 'Nebulized Budesonide Combined With Systemic Corticosteroid in Acute Severe Asthma', 'organization': {'class': 'OTHER', 'fullName': 'University of Monastir'}, 'officialTitle': 'Nebulized Budesonide Combined With Systemic Corticosteroid in Acute Severe Asthma Managed in the Emergency Department: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'University of Monastir'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Budesonide group', 'description': 'The experimental group received a first nebulization of 5 mg of terbutaline(solution of 5mg/ 2 ml ) in association with 0.5 mg of ipratropium bromide (solution of 0.5 mg/ 2 ml) and 0.5 mg of budesonide (solution of 0.5 mg/2 ml) followed by repetitive nebulization of 5 mg of terbutaline with 0.5 mg of budesonide at 20, 40, 60 and 120 min. All patients received hydrocortisone hemisuccinate (100 mg i.v.) and O2 (7 l/ min) via a nebulizer.', 'interventionNames': ['Drug: Budesonide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'normal saline', 'description': 'The control group received a nebulization of 2 ml normal saline at baseline, 20, 40, 60 and 120 min as placebo comparator in association with nebulized terbutaline . All patients received hydrocortisone hemisuccinate (100 mg i.v.) and O2 (7 l/ min) via a nebulizer.', 'interventionNames': ['Drug: normal saline']}], 'interventions': [{'name': 'Budesonide', 'type': 'DRUG', 'description': 'first nebulization of 0.5 mg of budesonide in association with terbutaline and ippratropium bromide followed by repetitive nebulization of 5 mg of terbutaline with 0.5 mg of budesonide at 20, 40, 60 and 120 min.', 'armGroupLabels': ['Budesonide group']}, {'name': 'normal saline', 'type': 'DRUG', 'description': 'first nebulization of 2ml of normal saline as placebo comparator in association with terbutaline and ippratropium bromide followed by repetitive nebulization of 5 mg of terbutaline with 2 ml of normal saline at 20, 40, 60 and 120 min.', 'armGroupLabels': ['normal saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5000', 'city': 'Monastir', 'status': 'RECRUITING', 'country': 'Tunisia', 'contacts': [{'name': 'Soudani Marghli, Professor', 'role': 'CONTACT', 'email': 'soudani.marghli@rns.tn', 'phone': '00 216 73 109 019'}, {'name': 'Chafiaa Bouhamed', 'role': 'CONTACT', 'email': 'bouhamedchafiaa@yahoo.fr', 'phone': '00 216 95 014 321'}, {'name': 'Soudani Marghli, Professor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Monastir', 'geoPoint': {'lat': 35.77799, 'lon': 10.82617}}], 'centralContacts': [{'name': 'Soudani Marghli, Professor', 'role': 'CONTACT', 'email': 'soudani.marghli@rns.tn', 'phone': '00 216 73 109 019'}, {'name': 'Chafiaa Bouhamed, Assistant Professor', 'role': 'CONTACT', 'email': 'bouhamedchafiaa@yahoo.fr', 'phone': '00 216 95 014 321'}], 'overallOfficials': [{'name': 'Soudani Marghli, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Monastir Tunisia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Monastir', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Soudani MARGHLI, MD', 'investigatorAffiliation': 'University of Monastir'}}}}