Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 5:39 AM
Study NCT ID:
NCT07426458
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-16
First Post:
2026-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ventilation and Perfusion in Asthmatics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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': 'D000068759', 'term': 'Formoterol Fumarate'}, {'id': 'D000069502', 'term': 'Budesonide, Formoterol Fumarate Drug Combination'}], 'ancestors': [{'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D019819', 'term': 'Budesonide'}, {'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': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2028-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-12', 'studyFirstSubmitDate': '2026-02-03', 'studyFirstSubmitQcDate': '2026-02-20', 'lastUpdatePostDateStruct': {'date': '2026-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Regional Ventilation', 'timeFrame': 'Baseline, 30 minutes after budesonide administration', 'description': 'Regional ventilation will be measured using functional lung imaging (XV LVAS) before and after inhalation of budesonide-formoterol. The outcome will be defined as the change in voxel-wise ventilation distribution from end expiration to peak inspiration, normalized to regional lung volume.'}], 'secondaryOutcomes': [{'measure': 'Change in Regional Mean Specific Perfusion', 'timeFrame': 'Baseline, 30 minutes after budesonide administration', 'description': 'Mean specific perfusion (MSP) will be measured using XV-LVAS-based flow maps derived from functional lung imaging. The reported value is a unitless regional perfusion ratio, calculated as Regional MSP divided by Total MSP. The outcome represents the change in this unitless metric between baseline imaging and follow-up imaging performed within 30 minutes after inhalation of budesonide.'}, {'measure': 'Percent Change in FEV₁ (Forced Expiratory Volume in 1 second)', 'timeFrame': 'Baseline, 60 minutes after budesonide administration', 'description': 'FEV₁ (Forced Expiratory Volume in 1 second) is the amount of air an individual can forcefully exhale in the first second of a maximal expiratory effort following a full inhalation. The FEV₁ will be measured before and after inhalation of budesonide-formoterol. The outcome is defined as the percent change in these values within the same visit, using standardized spirometry procedures.'}, {'measure': 'Percent Change in FVC (Forced Vital Capacity)', 'timeFrame': 'Baseline, 60 minutes after budesonide administration', 'description': 'FVC (Forced Vital Capacity) is the total volume of air that can be forcibly exhaled from the lungs after taking the deepest possible breath. The FVC, will be measured before and after inhalation of budesonide-formoterol. The outcome is defined as the percent change in these values within the same visit, using standardized spirometry procedures.'}, {'measure': 'Percent Change FEV₁/Forced Expiratory Volume (FVC) Ratio (Unitless)', 'timeFrame': 'Baseline, 30 minutes after budesonide administration', 'description': 'The outcome is defined as the change in the percent ratio of Forced Expiratory Volume in 1 second (FEV₁) to Forced Vital Capacity (FVC) between the pre- and post-intervention assessments. The FEV₁/FVC ratio (unitless) will be measured using standardized spirometry immediately before and 30 minutes after inhalation of budesonide-formoterol during the same study visit'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Asthma']}, 'descriptionModule': {'briefSummary': 'Assess regional changes to perfusion and ventilation from inhaled corticosteroid (ICS) and Fast-acting beta-antagonist (FABA) among adult asthmatics using radiographically derived estimates of regional ventilation (V-distribution), ventilation defect percentage (VDP), and ventilation heterogeneity (VH).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Physician diagnosis of asthma\n* Baseline Forced Expiratory Volume in 1 Second (FEV1) \\< 80% of predicted, with reversibility (10%) on post-bronchodilator spirometry\n* Adults, 18-75 years of age\n* Long-term inhaled controller medication consisting of or including an Inhaled corticosteroids (ICS) at a steady dose for at least 3 months before enrollment\n\nExclusion Criteria:\n\n* Current cigarette smoking or a past history of \\>10 pack-year smoking\n* Current nicotine vaping\n* Pregnant and breast-feeding women\n* Respiratory infection within 4 weeks of proposed study date\n* Forced Expiratory Volume in 1 Second (FEV1) \\< 50%\n* Inhaled corticosteroids (ICS)/fast-acting beta agonist (FABA) intolerance\n* Use of beta-blockers\n* Use of systemic glucocorticosteroids or oral methyl-xanthines within 30 days of planned study visit.'}, 'identificationModule': {'nctId': 'NCT07426458', 'briefTitle': 'Ventilation and Perfusion in Asthmatics', 'organization': {'class': 'OTHER', 'fullName': 'University of Miami'}, 'officialTitle': 'Ventilation and Perfusion in Individuals With Asthma', 'orgStudyIdInfo': {'id': '20251152'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Formoterol Followed by Budesonide-Formoterol', 'description': 'All participants in this single-arm study will complete 2 study visits, each lasting approximately 1 hour. Interventions will be administered in a sequential order.\n\nVisit 1: Participants will inhale formoterol via metered-dose inhaler (MDI) with spacer.\n\nVisit 2: Participants will inhale budesonide-formoterol via MDI with spacer as the second stage of treatment.', 'interventionNames': ['Drug: Formoterol', 'Drug: Budesonide/Formoterol']}], 'interventions': [{'name': 'Formoterol', 'type': 'DRUG', 'otherNames': ['PERFOROMIST', 'Formoterol Fumarate', 'Foradil'], 'description': 'Visit 1: Formoterol 4.5 μg (two puffs) will be administered via metered-dose inhaler (MDI) with spacer during the baseline study visit to obtain baseline imaging values.', 'armGroupLabels': ['Formoterol Followed by Budesonide-Formoterol']}, {'name': 'Budesonide/Formoterol', 'type': 'DRUG', 'otherNames': ['Symbicort'], 'description': 'Visit 2: Budesonide-formoterol 180-4.5 μg (two puffs) will be administered via MDI with spacer during this study visit. This intervention is used to evaluate its effect on ventilation defect percentage (VDP), ventilation heterogeneity (VH), and perfusion metrics derived from XV LVAS imaging', 'armGroupLabels': ['Formoterol Followed by Budesonide-Formoterol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'contacts': [{'name': 'Tiffany Salcito', 'role': 'CONTACT', 'email': 'tns93@med.miami.edu', 'phone': '305-243-2568'}, {'name': 'Trishul Siddharthan, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Miami - Converge Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'centralContacts': [{'name': 'Maria McCoy', 'role': 'CONTACT', 'email': 'mcm456@med.miami.edu', 'phone': '305-243-2568'}, {'name': 'Sonia Dipti Meena Velmurugan', 'role': 'CONTACT', 'email': 'sxm3597@med.miami.edu', 'phone': '305-243-2568'}], 'overallOfficials': [{'name': 'Trishul Siddharthan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Miami', 'class': 'OTHER'}, 'collaborators': [{'name': 'Australian Lung Health Initiative Pty Ltd', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Medicine', 'investigatorFullName': 'Trishul Siddharthan', 'investigatorAffiliation': 'University of Miami'}}}}