Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-28 @ 8:03 PM
Study NCT ID:
NCT04191434
Status:
UNKNOWN
Last Update Posted:
2022-07-27
First Post:
2019-12-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Flamboyant 125/12 Association in the Treatment of Adults With Moderate 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'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Double-blind and double-dummy'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 134}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-07-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2023-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-25', 'studyFirstSubmitDate': '2019-12-05', 'studyFirstSubmitQcDate': '2019-12-05', 'lastUpdatePostDateStruct': {'date': '2022-07-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in Forced expiratory volume in 1 second (FEV1), obtained through espirometry.', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': 'Incidence and severity of adverse events recorded during the study.', 'timeFrame': '14 weeks'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Asthma'], 'conditions': ['Asthma']}, 'referencesModule': {'references': [{'pmid': '36472162', 'type': 'DERIVED', 'citation': 'Oba Y, Anwer S, Maduke T, Patel T, Dias S. Effectiveness and tolerability of dual and triple combination inhaler therapies compared with each other and varying doses of inhaled corticosteroids in adolescents and adults with asthma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2022 Dec 6;12(12):CD013799. doi: 10.1002/14651858.CD013799.pub2.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of Flamboyant 125/12 association in adults with asthma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms;\n* Participants aged 18 years or more;\n* Diagnosis of uncontrolled moderate asthma;\n* Participants with Forced expiratory volume in 1 second (FEV1) \\> 60% of predicted;\n\nExclusion Criteria:\n\n* Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants;\n* Known hypersensitivity to the formula components used during the clinical trial;\n* History of alcohol and/or substance abuse within 12 months prior to Screening Visit.\n* Current smoking or smoking history equivalent to "10 pack years"\n* Participants with untreated oral candidiasis;\n* Pulmonary disease history (e.g., chronic obstructive pulmonary disease \\[COPD\\], cystic fibrosis, bronchiectasis, tuberculosis);\n* Participants with a history of acute asthma exacerbation, respiratory tract infection or hospitalization for asthma in the last 4 weeks;\n* Known HIV-positive status or active hepatitis B or C virus test result\n* Participants with current evidence or history of uncontrolled coronary artery disease, congestive heart failure, myocardial infarction or cardiac arrhythmia;\n* Participants with current medical history of cancer and/or cancer treatment in the last 5 years;\n* Participants using medications that would have an effect on bronchospasm and / or lung function.'}, 'identificationModule': {'nctId': 'NCT04191434', 'briefTitle': 'Efficacy and Safety of Flamboyant 125/12 Association in the Treatment of Adults With Moderate Asthma', 'organization': {'class': 'INDUSTRY', 'fullName': 'EMS'}, 'officialTitle': 'Multicenter, Randomized, Double-blind, Double-dummy, National, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Flamboyant 125/12 Association in the Treatment of Adults With Moderate Asthma .', 'orgStudyIdInfo': {'id': 'EMS0219 - FLAMBOYANT125/12'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FLAMBOYANT 125/12', 'description': 'The study is double-dummy. Thus, the participant must inhale 2 (two) capsules twice a day (12/12h), as follow:\n\n1 Flamboyant 125/12 capsule\n\n1 Budesonide/formoterol 200/6 Placebo capsule.', 'interventionNames': ['Drug: Flamboyant 125/12', 'Other: Budesonide/formoterol 200/6 placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Budesonide/formoterol 200/6', 'description': 'The study is double-dummy. Thus, the participant must inhale 2 (two) capsules twice a day (12/12h), as follow:\n\n1 Budesonide/formoterol 200/6 capsule\n\n1 Flamboyant 125/12 Placebo capsule.', 'interventionNames': ['Drug: Budesonide/formoterol 200/6', 'Other: Flamboyant 125/12 Placebo']}], 'interventions': [{'name': 'Flamboyant 125/12', 'type': 'DRUG', 'description': 'Flamboyant 125/12 capsule', 'armGroupLabels': ['FLAMBOYANT 125/12']}, {'name': 'Budesonide/formoterol 200/6', 'type': 'DRUG', 'description': 'Budesonid/formoterol 200/6 capsule', 'armGroupLabels': ['Budesonide/formoterol 200/6']}, {'name': 'Flamboyant 125/12 Placebo', 'type': 'OTHER', 'description': 'Flamboyant 125/12 Placebo capsule', 'armGroupLabels': ['Budesonide/formoterol 200/6']}, {'name': 'Budesonide/formoterol 200/6 placebo', 'type': 'OTHER', 'description': 'Budesonid/formoterol 200/6 Placebo capsule', 'armGroupLabels': ['FLAMBOYANT 125/12']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Cynthia Dullius', 'role': 'CONTACT'}], 'facility': 'Insight Pesquisa Clínica', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'city': 'Tatuí', 'state': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'facility': 'IMC Tatuí', 'geoPoint': {'lat': -23.35556, 'lon': -47.85694}}, {'city': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Flávio G Lastebasse, MD', 'role': 'CONTACT'}], 'facility': 'CPCLin', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'centralContacts': [{'name': 'Alexandra Dumont Alves, MD', 'role': 'CONTACT', 'email': 'pesquisa.clinica@ncfarma.com.br', 'phone': '+551938879851'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'EMS', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}