Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2025-12-25 @ 9:52 PM
Study NCT ID:
NCT06245551
Status:
COMPLETED
Last Update Posted:
2025-08-27
First Post:
2023-12-13
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study to Investigate the Effects of PT027 (Budesonide/Albuterol Sulfate) Metered-dose Inhaler Compared With Placebo on Exercise-Induced Bronchoconstriction in Adult Patients With Asthma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D001250', 'term': 'Asthma, Exercise-Induced'}, {'id': 'D001249', 'term': 'Asthma'}, {'id': 'D000092202', 'term': 'Exercise-Induced Allergies'}, {'id': 'D001986', 'term': 'Bronchial Spasm'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung 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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'information.center@astrazeneca.com', 'phone': '1-877-240-9479', 'title': 'Global Clinical Lead', 'organization': 'AstraZeneca'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events presented in the tables below were collected during up to 19 days from the time of first study treatment to follow-up telephone call. Actual time for each participant depends on duration of their participation in the study.', 'eventGroups': [{'id': 'EG000', 'title': 'BDA MDI 160/180', 'description': 'Participants administered BDA MDI 160/180 during 1st or 2nd period', 'otherNumAtRisk': 64, 'deathsNumAtRisk': 64, 'otherNumAffected': 1, 'seriousNumAtRisk': 64, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Participants administered placebo during 1st or 2nd period', 'otherNumAtRisk': 64, 'deathsNumAtRisk': 64, 'otherNumAffected': 2, 'seriousNumAtRisk': 64, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27'}, {'term': 'Bronchial irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Maximum Percentage Fall From Post-dose, Pre-exercise Baseline in Forced Expiratory Volume in 1 Second (FEV₁) Observed up to 60 Minutes Post-exercise Challenge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BDA MDI 160/180', 'description': 'Participants administered BDA MDI 160/180 during 1st or 2nd period'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants administered placebo during 1st or 2nd period'}], 'classes': [{'title': 'All subjects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.95', 'groupId': 'OG000', 'lowerLimit': '5.36', 'upperLimit': '8.54'}, {'value': '24.46', 'groupId': 'OG001', 'lowerLimit': '22.87', 'upperLimit': '26.05'}]}]}, {'title': 'Non-ICS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.28', 'groupId': 'OG000', 'lowerLimit': '3.63', 'upperLimit': '8.93'}, {'value': '26.62', 'groupId': 'OG001', 'lowerLimit': '23.97', 'upperLimit': '29.28'}]}]}, {'title': 'ICS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.29', 'groupId': 'OG000', 'lowerLimit': '5.32', 'upperLimit': '9.25'}, {'value': '23.28', 'groupId': 'OG001', 'lowerLimit': '21.32', 'upperLimit': '25.25'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-17.52', 'ciLowerLimit': '-19.78', 'ciUpperLimit': '-15.25', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The analysis is applied to the All-subjects data.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Up to 60 minutes post-exercise challenge', 'description': 'Lung function was measured by spirometry. Spirometry assessments were completed 5 minutes before dosing, 30 minutes after dosing (baseline; 5 minutes before the exercise challenge), and then 5, 10, 15, 30, and 60 minutes after the exercise challenge. A reduction in FEV₁ was expected due to the effects of asthma and exercise on breathing and lung function. The percentage fall in FEV₁ was calculated based on the baseline value and maximum percentage fall value during the 60-minute assessment period.', 'unitOfMeasure': 'Percent fall', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects With a Maximum Percentage Fall in FEV₁ Post-exercise Challenge of <10% and <20%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BDA MDI 160/180', 'description': 'Participants administered BDA MDI 160/180 during 1st or 2nd period'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants administered placebo during 1st or 2nd period'}], 'classes': [{'title': 'Maximum percentage fall <10%', 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Maximum percentage fall <20%', 'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 60 minutes post exercise challenge', 'description': 'The percentage fall in FEV₁ was calculated based on the baseline value and maximum percentage fall value during the 60-minute assessment period, and the percentage of subjects with a maximum percentage fall \\<10% and \\<20% was determined', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage Fall From Post-dose, Pre-exercise Baseline in FEV1 at Each Time Point Within 60 Minutes Post-exercise Challenge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BDA MDI 160/180', 'description': 'Participants administered BDA MDI 160/180 during 1st or 2nd period'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants administered placebo during 1st or 2nd period'}], 'classes': [{'title': '5 min Post-ECT', 'categories': [{'measurements': [{'value': '1.68', 'groupId': 'OG000', 'lowerLimit': '-0.11', 'upperLimit': '3.47'}, {'value': '9.79', 'groupId': 'OG001', 'lowerLimit': '8.00', 'upperLimit': '11.58'}]}]}, {'title': '10 min Post-ECT', 'categories': [{'measurements': [{'value': '3.16', 'groupId': 'OG000', 'lowerLimit': '1.30', 'upperLimit': '5.02'}, {'value': '17.98', 'groupId': 'OG001', 'lowerLimit': '16.12', 'upperLimit': '19.84'}]}]}, {'title': '15 min Post-ECT', 'categories': [{'measurements': [{'value': '4.20', 'groupId': 'OG000', 'lowerLimit': '2.38', 'upperLimit': '6.03'}, {'value': '19.14', 'groupId': 'OG001', 'lowerLimit': '17.31', 'upperLimit': '20.97'}]}]}, {'title': '30 min Post-ECT', 'categories': [{'measurements': [{'value': '2.64', 'groupId': 'OG000', 'lowerLimit': '0.65', 'upperLimit': '4.63'}, {'value': '11.85', 'groupId': 'OG001', 'lowerLimit': '9.87', 'upperLimit': '13.84'}]}]}, {'title': '60 min Post-ECT', 'categories': [{'measurements': [{'value': '0.56', 'groupId': 'OG000', 'lowerLimit': '-0.83', 'upperLimit': '1.94'}, {'value': '3.10', 'groupId': 'OG001', 'lowerLimit': '1.72', 'upperLimit': '4.48'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Up to 60 minutes post exercise challenge', 'description': 'The percentage fall in FEV₁ at each time point was calculated based on the baseline value and percentage fall value during the 60-minute assessment period at each time point.', 'unitOfMeasure': 'Percent', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Post-Exercise FEV1 Area Under the Curve From 0 to 30 Minutes (AUC0-30min)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BDA MDI 160/180', 'description': 'Participants administered BDA MDI 160/180 during 1st or 2nd period'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants administered placebo during 1st or 2nd period'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.10', 'spread': '0.16', 'groupId': 'OG000'}, {'value': '-0.44', 'spread': '0.23', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 30 minutes post exercise challenge', 'description': 'FEV1 AUC0-30min will be derived for the changes from the post-dose, pre-exercise baseline using the trapezoidal rule and will be normalized by dividing by the actual time (in minutes) from dosing to the last included measurement, scheduled at 30 minutes post-exercise challenge.', 'unitOfMeasure': 'liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time To Recovery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BDA MDI 160/180', 'description': 'Participants administered BDA MDI 160/180 during 1st or 2nd period'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants administered placebo during 1st or 2nd period'}], 'classes': [{'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 60 minutes post exercise challenge', 'description': 'Time to recovery will be derived as the time (minutes) post-exercise challenge in which the FEV1 result returns to within 10% of the value recorded at the post-dose, pre-exercise baseline.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BDA MDI 160/180', 'description': 'Participants administered BDA MDI 160/180 during 1st or 2nd period'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants administered placebo during 1st or 2nd period'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through study completion, an average of 4 weeks', 'description': 'The safety profile will be evaluated using vital signs, physical examination, electrocardiograms (ECGs) and AE data.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Budesonide/Albuterol Metered-dose Inhaler (BDA MDI) 160/180 - Placebo', 'description': 'Participants administered BDA MDI 160/180 during 1st period and placebo in 2nd period'}, {'id': 'FG001', 'title': 'Placebo - Budesonide/Albuterol Metered-dose Inhaler (BDA MDI) 160/180', 'description': 'Participants administered placebo during 1st period and BDA MDI 160/180 in 2nd period'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '33'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '33'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': '1st Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '33'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '33'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': '2nd Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '33'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '33'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Budesonide/Albuterol Metered-dose Inhaler (BDA MDI) 160/180 - Placebo', 'description': 'Participants administered BDA MDI 160/180 during 1st period and placebo in 2nd period'}, {'id': 'BG001', 'title': 'Placebo - Budesonide/Albuterol Metered-dose Inhaler (BDA MDI) 160/180', 'description': 'Participants administered placebo during 1st period and BDA MDI 160/180 in 2nd period'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '39.0', 'spread': '14.5', 'groupId': 'BG000'}, {'value': '43.2', 'spread': '13.9', 'groupId': 'BG001'}, {'value': '41.1', 'spread': '14.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '< 65 years', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}]}, {'title': '>= 65 years', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Not Hispanic or Latino', 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}]}, {'title': 'Not Reported', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Pre-dose pre-exercise challenge test (ECT) forced expiratory volume in 1 second (FEV1)', 'classes': [{'categories': [{'measurements': [{'value': '2.925', 'spread': '0.826', 'groupId': 'BG000'}, {'value': '3.042', 'spread': '0.877', 'groupId': 'BG001'}, {'value': '2.985', 'spread': '0.848', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'liters', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-08-29', 'size': 2293886, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-06-11T07:32', 'hasProtocol': True}, {'date': '2024-08-06', 'size': 1097100, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-06-11T07:32', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-12-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2024-06-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-08', 'studyFirstSubmitDate': '2023-12-13', 'resultsFirstSubmitDate': '2025-06-11', 'studyFirstSubmitQcDate': '2024-01-29', 'lastUpdatePostDateStruct': {'date': '2025-08-27', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-08-08', 'studyFirstPostDateStruct': {'date': '2024-02-07', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-08-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-06-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Participants With Adverse Events (AEs)', 'timeFrame': 'Through study completion, an average of 4 weeks', 'description': 'The safety profile will be evaluated using vital signs, physical examination, electrocardiograms (ECGs) and AE data.'}], 'primaryOutcomes': [{'measure': 'Maximum Percentage Fall From Post-dose, Pre-exercise Baseline in Forced Expiratory Volume in 1 Second (FEV₁) Observed up to 60 Minutes Post-exercise Challenge', 'timeFrame': 'Up to 60 minutes post-exercise challenge', 'description': 'Lung function was measured by spirometry. Spirometry assessments were completed 5 minutes before dosing, 30 minutes after dosing (baseline; 5 minutes before the exercise challenge), and then 5, 10, 15, 30, and 60 minutes after the exercise challenge. A reduction in FEV₁ was expected due to the effects of asthma and exercise on breathing and lung function. The percentage fall in FEV₁ was calculated based on the baseline value and maximum percentage fall value during the 60-minute assessment period.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Subjects With a Maximum Percentage Fall in FEV₁ Post-exercise Challenge of <10% and <20%', 'timeFrame': 'Up to 60 minutes post exercise challenge', 'description': 'The percentage fall in FEV₁ was calculated based on the baseline value and maximum percentage fall value during the 60-minute assessment period, and the percentage of subjects with a maximum percentage fall \\<10% and \\<20% was determined'}, {'measure': 'Percentage Fall From Post-dose, Pre-exercise Baseline in FEV1 at Each Time Point Within 60 Minutes Post-exercise Challenge', 'timeFrame': 'Up to 60 minutes post exercise challenge', 'description': 'The percentage fall in FEV₁ at each time point was calculated based on the baseline value and percentage fall value during the 60-minute assessment period at each time point.'}, {'measure': 'Post-Exercise FEV1 Area Under the Curve From 0 to 30 Minutes (AUC0-30min)', 'timeFrame': 'Up to 30 minutes post exercise challenge', 'description': 'FEV1 AUC0-30min will be derived for the changes from the post-dose, pre-exercise baseline using the trapezoidal rule and will be normalized by dividing by the actual time (in minutes) from dosing to the last included measurement, scheduled at 30 minutes post-exercise challenge.'}, {'measure': 'Time To Recovery', 'timeFrame': 'Up to 60 minutes post exercise challenge', 'description': 'Time to recovery will be derived as the time (minutes) post-exercise challenge in which the FEV1 result returns to within 10% of the value recorded at the post-dose, pre-exercise baseline.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Asthma', 'Exercise-Induced Allergies', 'Bronchial Spasm', 'Albuterol', 'Budesonide', 'Bronchodilator Agents', 'Anti-Inflammatory Agents'], 'conditions': ['Asthma, Exercise-Induced']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=AZ-RU-00004&attachmentIdentifier=8eabc9e6-e53d-4c17-aaae-9b10b2e08ce2&fileName=AZ-RU-00004_CSP_Redacted.pdf&versionIdentifier=', 'label': 'AZ-RU-00004\\_CSP\\_Redacted'}, {'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=AZ-RU-00004&attachmentIdentifier=ae80b3f5-d4df-40a3-9541-335da5e4ba22&fileName=AZ-RU-00004_Statistical_Analysis_Plan_Redacted.pdf&versionIdentifier=', 'label': 'AZ-RU-00004\\_Statistical Analysis Plan\\_Redacted'}, {'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=AZ-RU-00004&attachmentIdentifier=60ac9ac9-d79d-4285-a0da-81c01107d24c&fileName=AZ-RU-00004_CSR_Synopsis_Redacted.pdf&versionIdentifier=', 'label': 'AZ-RU-00004\\_CSR Synopsis\\_Redacted'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this Phase III, multicentre, randomized, double-blind, single-dose, 2-period, crossover study is to assess the efficacy and safety of PT027 (budesonide/albuterol sulfate) metered-dose inhaler compared with placebo on exercise-induced bronchoconstriction in adult patients with asthma. Subjects will receive each study treatment on separate visits and undergo a treadmill exercise challenge test so that the effect of study treatment on exercise-induced bronchoconstriction can be evaluated'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Female or male aged 18 to 70 years at the time of informed consent.\n2. Documented history of asthma for at least 6 months prior to Visit 1\n3. Receiving 1 of the following asthma therapies with stable dosing for at least the 4 weeks before Visit 1 (no other asthma therapies are permitted during the study):\n\n * Short-acting β 2-adrenoreceptor agonist (SABA) used as needed;\n * Low- to medium-dose maintenance therapy with inhaled corticosteroid (ICS) and SABA used as needed.\n4. Demonstrate acceptable MDI administration technique (use of a spacer device during the treatment phase is not permitted)\n\nExclusion Criteria:\n\n1. Chronic obstructive pulmonary disease or other significant lung disease (eg, chronic bronchitis, emphysema, bronchiectasis with the need of treatment, cystic fibrosis, bronchopulmonary dysplasia), including regular or occasional use of oxygen.\n2. Systemic corticosteroids (SCS) use (any dose and any indication) within 3 months before Visit 1.\n3. History of life-threatening asthma, defined by past intubations for asthma, or intensive care unit admission for asthma within the prior 24 months.\n4. Receiving regular maintenance treatment with prohibited anti-inflammatory or long-acting bronchodilator asthma medication (inhaled, nebulized, oral, or systemic) within 1 month prior to Visit 1.\n5. Unable to tolerate the lung function testing performed after exercise challenge test without use of rescue medication.\n6. Current smokers, former smokers with \\>10 pack-years history, or former smokers who stopped smoking \\<6 months before Visit 1 (including all forms of tobacco, e-cigarettes \\[vaping\\], and marijuana).\n7. Completed treatment for lower respiratory infection within 6 weeks prior to Visit 1, regardless if resulting in accompanying asthma symptoms aggravation or not.\n8. Upper respiratory infection involving antibiotic treatment not resolved within 7 days prior to Visit 1.\n9. Received any marketed (eg, omalizumab, mepolizumab, reslizumab, benralizumab, dupilumab) or investigational biologic within 3 months before Visit 1, or any other prohibited medication.\n10. Historical or current evidence of a clinically significant disease.\n11. History of psychiatric disease or intellectual deficiency.\n12. Having a scheduled or planned hospitalization during the study.\n13. Inability (and/or unwillingness) to abstain from protocol-defined prohibited medications during the study.\n14. Use of any herbal products by inhalation or nebulizer within 2 weeks of Visit 1 and/or the unwillingness to stop during the study duration.\n15. Significant abuse of alcohol or drugs.'}, 'identificationModule': {'nctId': 'NCT06245551', 'acronym': 'BREATH', 'briefTitle': 'A Study to Investigate the Effects of PT027 (Budesonide/Albuterol Sulfate) Metered-dose Inhaler Compared With Placebo on Exercise-Induced Bronchoconstriction in Adult Patients With Asthma', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Phase III, Multicentre, Randomized, Double-blind, Single-Dose, 2-Arm, 2-Period, Crossover Study to Investigate the Efficacy of PT027 Compared With Placebo on Exercise-Induced Bronchoconstriction in Adult Patients With Asthma (BREATH)', 'orgStudyIdInfo': {'id': 'AZ-RU-00004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A/B - Treatment with PT027 (BUDESONIDE/ALBUTEROL) 160/180 μg followed by treatment with Placebo', 'description': 'Subjects randomized to receive a single dose of PT027 160/180 μg in treatment Period 1, and a single dose of Placebo in treatment Period 2.', 'interventionNames': ['Drug: Budesonide/albuterol metered-dose inhaler 160/180 μg', 'Drug: Placebo metered-dose inhaler']}, {'type': 'EXPERIMENTAL', 'label': 'B/A - Treatment with Placebo followed by treatment with PT027 (BUDESONIDE/ALBUTEROL) 160/180 μg', 'description': 'Subjects randomized to receive a single dose of Placebo in treatment Period 1, and a single dose of PT027 160/180 in treatment Period 2.', 'interventionNames': ['Drug: Budesonide/albuterol metered-dose inhaler 160/180 μg', 'Drug: Placebo metered-dose inhaler']}], 'interventions': [{'name': 'Budesonide/albuterol metered-dose inhaler 160/180 μg', 'type': 'DRUG', 'otherNames': ['PT027 (BDA MDI) 160/180 μg'], 'description': 'Budesonide/albuterol combination aerosol for inhalation, single dose (given as 2 actuations of 80/90 μg)', 'armGroupLabels': ['A/B - Treatment with PT027 (BUDESONIDE/ALBUTEROL) 160/180 μg followed by treatment with Placebo', 'B/A - Treatment with Placebo followed by treatment with PT027 (BUDESONIDE/ALBUTEROL) 160/180 μg']}, {'name': 'Placebo metered-dose inhaler', 'type': 'DRUG', 'otherNames': ['Placebo MDI'], 'description': 'Placebo aerosol for inhalation, single dose (given as 2 actuations)', 'armGroupLabels': ['A/B - Treatment with PT027 (BUDESONIDE/ALBUTEROL) 160/180 μg followed by treatment with Placebo', 'B/A - Treatment with Placebo followed by treatment with PT027 (BUDESONIDE/ALBUTEROL) 160/180 μg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '105554', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '440067', 'city': 'Penza', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 53.19568, 'lon': 45.01075}}, {'zip': '614000', 'city': 'Perm', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 58.01046, 'lon': 56.25017}}, {'zip': '192071', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '410054', 'city': 'Saratov', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 51.54048, 'lon': 45.9901}}, {'zip': '432009', 'city': 'Ulyanovsk', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 54.32824, 'lon': 48.38657}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}