Ignite Creation Date:
2025-12-24 @ 4:35 PM
Ignite Modification Date:
2026-01-04 @ 8:33 AM
Study NCT ID:
NCT06502366
Status:
RECRUITING
Last Update Posted:
2025-12-15
First Post:
2024-07-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Investigate the Effect on Lung Function of BDA Formulated With a Next Generation Propellant Compared With an Approved Asthma Treatment (BDA With HFA Propellant) in Participants With 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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Double blind'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'This is a Randomized, Placebo-controlled, Double-blind, Multicenter, 12-Week, 3-Way, Partial-replicate Crossover Pharmacodynamic Study to Assess the Equivalence of BDA MDI HFO Compared with BDA MDI HFA in Participants with Asthma.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 398}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-03-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-09', 'studyFirstSubmitDate': '2024-07-09', 'studyFirstSubmitQcDate': '2024-07-09', 'lastUpdatePostDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-07-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in peak FEV1 in 0-60 minutes after dosing at Day 29', 'timeFrame': 'Change from baseline at Day 29', 'description': 'To assess the equivalence of BDA MDI HFO relative to BDA MDI HFA on lung function in participants with asthma.'}, {'measure': 'Change from baseline in peak FEV1 in 0-60 minutes after dosing at Day 29', 'timeFrame': 'Change from baseline at Day 29', 'description': 'To demonstrate assay sensitivity via superiority of BDA MDI HFA relative to placebo MDI HFA on lung function in participants with asthma'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in morning pre-dose trough FEV1', 'timeFrame': 'Change from baseline at Day 29', 'description': 'To assess the equivalence of BDA MDI HFO relative to BDA MDI HFA on lung function in participants with asthma.'}, {'measure': 'Change from baseline in morning pre-dose trough FEV1', 'timeFrame': 'Change from baseline at Day 29', 'description': 'To demonstrate assay sensitivity via superiority of BDA MDI HFA relative to placebo MDI HFA on lung function in participants with asthma'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Asthma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the PD equivalence of the approved asthma combination therapy, BDA, delivered using the proposed replacement propellant HFO compared with BDA delivered using the currently approved propellant HFA in participants with asthma.', 'detailedDescription': 'The purpose of this study is to assess the PD equivalence of the approved asthma combination therapy, BDA, delivered using the proposed replacement propellant HFO compared with BDA delivered using the currently approved propellant HFA in participants with asthma.\n\nThe study duration for each participant will be approximately 14 to 15 weeks and will consist of:\n\n1. A screening and placebo run-in period of approximately 2 weeks prior to the first dose of study intervention\n2. 3 treatment periods of 4 weeks each\n3. A final safety follow-up visit via telephone contact approximately 5 days after the final dose of study intervention\n\nParticipants will attend in-clinic visits 2 weeks apart during the screening/run-in period (Visits 1 and 2) and then every 4 weeks during the treatment period (Visits 3, 4, and 5).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participant must be ≥ 18 years of age at the time of signing the ICF.\n* Participants who have physician diagnosed asthma as defined by GINA for at least 12 months prior to Visit 1.\n* Eligible participants are on either a) no daily inhaled maintenance therapy or b) daily inhaled maintenance therapy with low-dose ICS or low-dose ICS-LABA. Participants who are on low-dose ICS maintenance therapy are required to be stable on therapy for a minimum of 3 months prior to Visit 1; participants using low-dose ICSLABA maintenance regimens are required to be stable on therapy for a minimum of 6 months prior to Visit 1.\n* Participants with a pre-bronchodilator FEV1 of ≥ 60% and \\< 90% predicted normal at Visit 1 or Visit 1a.\n* Participants with a pre-dose FEV1 of ≥ 60% and \\< 90% predicted normal at Visit 2 that is within ± 20% of their Visit 1 pre-bronchodilator FEV1.\n* Participants who demonstrate bronchodilator responsiveness defined as a \\> 12% and \\> 200 mL increase in FEV1 relative to baseline following administration of study provided SABA at Visit 1 or Visit 1a.\n* Participants able to demonstrate acceptable spirometry performance as defined by the acceptability and repeatability criteria in the ATS/ERS Standardization of Spirometry 2019 update\n* Participants who are willing and, in the opinion of the investigator, able to adjust current asthma therapy, as required by the protocol.\n* Participants with a body mass index \\< 40 kg/m2.\n* Females must not be of childbearing potential or, if of childbearing potential, using a form of birth control\n\nExclusion Criteria:\n\n* Confirmed or suspected diagnosis of COPD or clinically significant non-asthma airway/lung disease.\n* Systemic corticosteroid use (eg, prednisone for 3 or more days or a single depo-injectable dose of corticosteroids) for any respiratory, immune, or allergy-attributed disease within 6 months prior to Visit 1.\n* An upper respiratory infection requiring antibiotic treatment that is not resolved within 7 days prior to Visit 1.\n* A lower respiratory infection in the 4 weeks prior to Visit 1.\n* Life-threatening asthma defined as any history of significant asthma episode(s) requiring admission to an intensive care unit, positive pressure ventilation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma-related syncopal episode(s) within 5 years of Visit 1.\n* Hospitalization due to asthma within 12 months or systemic corticosteroid usage (eg, prednisone for 3 or more days or a single depo-injectable dose of corticosteroids) for asthma within 6 months prior to Visit 1.\n* A severe asthma exacerbation during the run-in period\n* An ePRO device alert during the run-in period with investigator-confirmed worsening asthma symptoms\n* Historical or current evidence of a clinically significant disease including, but not limited to: cardiovascular (eg, congestive heart failure, known aortic aneurysm, clinically significant cardiac arrhythmia, coronary heart disease), hepatic, renal, hematological, neuropsychological, endocrine (eg, uncontrolled diabetes mellitus, uncontrolled thyroid disorder, Addison's disease, Cushing's syndrome), or gastrointestinal (eg, poorly controlled peptic ulcer, gastroesophageal reflux disease) disorders. Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the participant at risk through study participation or that could affect the efficacy or safety analyses if the disease/condition exacerbated during the study.\n* Unresectable cancer that has not been in complete remission for at least 5 years prior to Visit 1\n* Hospitalization for psychiatric disorder or attempted suicide within 1 year of Visit 1.\n* Known history of drug or alcohol abuse within 12 months of Visit 1 or known abuse at any time during the study."}, 'identificationModule': {'nctId': 'NCT06502366', 'briefTitle': 'A Study to Investigate the Effect on Lung Function of BDA Formulated With a Next Generation Propellant Compared With an Approved Asthma Treatment (BDA With HFA Propellant) in Participants With Asthma', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Randomized, Placebo-controlled, Double-blind, Multicenter, 12-Week, 3-Way, Partial-replicate Crossover Pharmacodynamic Study to Assess the Equivalence of Budesonide and Albuterol (BDA) Delivered by MDI HFO Compared With BDA Delivered by MDI HFA in Participants With Asthma', 'orgStudyIdInfo': {'id': 'D6933C00002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'BDA MDI HFO', 'description': '160/180 µg Budesonide/albuterol pressurized inhalation suspension, HFO', 'interventionNames': ['Drug: BDA MDI HFO 160/180 μg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'BDA MDI HFA', 'description': '160/180 µg Budesonide/albuterol pressurized inhalation suspension, HFA', 'interventionNames': ['Drug: BDA MDI HFA 160/180 μg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo MDI HFA', 'description': 'Placebo pressurized inhalation suspension, HFA', 'interventionNames': ['Drug: Placebo MDI HFA']}], 'interventions': [{'name': 'BDA MDI HFO 160/180 μg', 'type': 'DRUG', 'description': 'Budesonide/albuterol pressurized inhalation suspension, HFO', 'armGroupLabels': ['BDA MDI HFO']}, {'name': 'BDA MDI HFA 160/180 μg', 'type': 'DRUG', 'description': 'Budesonide/albuterol pressurized inhalation suspension, HFA', 'armGroupLabels': ['BDA MDI HFA']}, {'name': 'Placebo MDI HFA', 'type': 'DRUG', 'description': 'Placebo pressurized inhalation suspension, HFA', 'armGroupLabels': ['Placebo MDI HFA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36608', 'city': 'Mobile', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '35660', 'city': 'Sheffield', 'state': 'Alabama', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.76509, 'lon': -87.69864}}, {'zip': '85018', 'city': 'Phoenix', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '72205', 'city': 'Little 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