Ignite Creation Date:
2025-12-24 @ 3:25 PM
Ignite Modification Date:
2026-03-13 @ 3:04 PM
Study NCT ID:
NCT00667992
Status:
COMPLETED
Last Update Posted:
2012-11-07
First Post:
2008-04-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study Comparing Budesonide Hydrofluoroalkane (HFA) vs Chlorofluorocarbon (CFC) Pressurized Metered Dose Inhalers (pMDI) in Patients With Mild to Moderate Asthma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'aztrial_results_posting@astrazeneca.com', 'title': 'Gerard Lynch', 'organization': 'AstraZeneca'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Budesonide Hydrofluoroalkane (HFA) 100', 'description': 'Budesonide Hydrofluoroalkane (HFA) 100 mcg twice daily for 2 weeks', 'otherNumAtRisk': 86, 'otherNumAffected': 0, 'seriousNumAtRisk': 86, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Budesonide HFA 400', 'description': 'Budesonide HFA 400 mcg twice daily for 2 weeks', 'otherNumAtRisk': 81, 'otherNumAffected': 0, 'seriousNumAtRisk': 81, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Budesonide Chlorofluorocarbon (CFC) 100', 'description': 'Budesonide Chlorofluorocarbon (CFC) 100 mcg twice daily for 2 weeks', 'otherNumAtRisk': 85, 'otherNumAffected': 0, 'seriousNumAtRisk': 85, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': 'Budesonide CFC 400', 'description': 'Budesonide CFC 400 mcg twice daily for 2 weeks', 'otherNumAtRisk': 79, 'otherNumAffected': 0, 'seriousNumAtRisk': 79, 'seriousNumAffected': 0}], 'seriousEvents': [{'term': 'Oral Candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRa 10.0'}, {'term': 'Lower Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRa 10.0'}, {'term': 'Respiratory Tract Infection Viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRa 10.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'PC 20 Methacholine (Provocative Concentration of Methacholine Causing 20 % Fall in FEV1(Forced Expiratory Volume)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Budesonide Hydrofluoroalkane (HFA) 100', 'description': 'Budesonide Hydrofluoroalkane (HFA) 100 mcg twice daily for 2 weeks'}, {'id': 'OG001', 'title': 'Budesonide HFA 400', 'description': 'Budesonide HFA 400 mcg twice daily for 2 weeks'}, {'id': 'OG002', 'title': 'Budesonide Chlorofluorocarbon(CFC) 100', 'description': 'Budesonide Chlorofluorocarbon (CFC) 100 mcg twice daily for 2 weeks'}, {'id': 'OG003', 'title': 'Budesonide CFC 400', 'description': 'Budesonide CFC 400 mcg twice daily for 2 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '1.546', 'groupId': 'OG000', 'lowerLimit': '1.343', 'upperLimit': '1.780'}, {'value': '2.163', 'groupId': 'OG001', 'lowerLimit': '1.877', 'upperLimit': '2.494'}, {'value': '1.673', 'groupId': 'OG002', 'lowerLimit': '1.449', 'upperLimit': '1.928'}, {'value': '2.079', 'groupId': 'OG003', 'lowerLimit': '1.801', 'upperLimit': '2.401'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline and week 2', 'description': 'Provocative concentration of methacholine is that causing a 20% fall in FEV1. The methacholine challenge test entailed the patient inhaling from an aerosol containing doubling concentrations of methacholine over a period of 2 minutes until FEV1 had been reduced by 20%.\n\nThe ratio of Methacholine concentration measured at 2 weeks to that at Baseline.', 'unitOfMeasure': 'Ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS). The FAS was defined as all randomised patients who contributed data from at least one period (ie data from both low and high dose of one inhaler).'}, {'type': 'SECONDARY', 'title': 'Peak Exploratory Flow (PEF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Budesonide Hydrofluoroalkane (HFA) 100', 'description': 'Budesonide Hydrofluoroalkane (HFA) 100 mcg twice daily for 2 weeks'}, {'id': 'OG001', 'title': 'Budesonide HFA 400', 'description': 'Budesonide HFA 400 mcg twice daily for 2 weeks'}, {'id': 'OG002', 'title': 'Budesonide Chlorofluorocarbon(CFC) 100', 'description': 'Budesonide Chlorofluorocarbon(CFC) 100 mcg twice daily for 2 weeks'}, {'id': 'OG003', 'title': 'Budesonide CFC 400', 'description': 'Budesonide CFC 400 mcg twice daily for 2 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '9.7', 'groupId': 'OG000', 'lowerLimit': '3.9', 'upperLimit': '15.6'}, {'value': '12.7', 'groupId': 'OG001', 'lowerLimit': '6.8', 'upperLimit': '18.6'}, {'value': '12.0', 'groupId': 'OG002', 'lowerLimit': '6.1', 'upperLimit': '17.9'}, {'value': '9.1', 'groupId': 'OG003', 'lowerLimit': '3.2', 'upperLimit': '15.1'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to week 2 recorded daily', 'description': 'Change in PEF at Week 2 from baseline, mean over all days in run-in and all dasy in treatment period, with baseline as covariate.', 'unitOfMeasure': 'Liters/minutes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS). The FAS was defined as all randomised patients who contributed data from at least one period (ie data from both low and high dose of one inhaler).'}, {'type': 'SECONDARY', 'title': 'FEV1 (Forced Expiratory Volume in 1 Second)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Budesonide Hydrofluoroalkane(HFA) 100', 'description': 'Budesonide Hydrofluoroalkane(HFA) 100 mcg twice daily for 2 weeks'}, {'id': 'OG001', 'title': 'Budesonide HFA 400', 'description': 'Budesonide HFA 400 mcg twice daily for 2 weeks'}, {'id': 'OG002', 'title': 'Budesonide Chlorofluorocarbon (CFC) 100', 'description': 'Budesonide Chlorofluorocarbon(CFC) 100 mcg twice daily for 2 weeks'}, {'id': 'OG003', 'title': 'Budesonide CFC 400', 'description': 'Budesonide CFC 400 mcg twice daily for 2 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.08', 'groupId': 'OG000', 'lowerLimit': '0.05', 'upperLimit': '0.11'}, {'value': '0.10', 'groupId': 'OG001', 'lowerLimit': '0.07', 'upperLimit': '0.13'}, {'value': '0.10', 'groupId': 'OG002', 'lowerLimit': '0.07', 'upperLimit': '0.13'}, {'value': '0.11', 'groupId': 'OG003', 'lowerLimit': '0.08', 'upperLimit': '0.14'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to week 2', 'description': 'FEV1 change from baseline', 'unitOfMeasure': 'Liters', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS). The FAS was defined as all randomised patients who contributed data from at least one period (ie data from both low and high dose of one inhaler).'}, {'type': 'SECONDARY', 'title': 'FEF 25-75 (Forced Expiratory Flow 25-75)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Budesonide Hydrofluoroalkane(HFA) 100', 'description': 'Budesonide Hydrofluoroalkane(HFA) 100 mcg twice daily for 2 weeks'}, {'id': 'OG001', 'title': 'Budesonide HFA 400', 'description': 'Budesonide HFA 400 mcg twice daily for 2 weeks'}, {'id': 'OG002', 'title': 'Budesonide Chlorofluorocarbon (CFC) 100', 'description': 'Budesonide Chlorofluorocarbon(CFC) 100 mcg twice daily for 2 weeks'}, {'id': 'OG003', 'title': 'Budesonide CFC 400', 'description': 'Budesonide CFC 400 mcg twice daily for 2 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.11', 'groupId': 'OG000', 'lowerLimit': '0.005', 'upperLimit': '0.17'}, {'value': '0.14', 'groupId': 'OG001', 'lowerLimit': '0.08', 'upperLimit': '0.20'}, {'value': '0.15', 'groupId': 'OG002', 'lowerLimit': '0.09', 'upperLimit': '0.21'}, {'value': '0.20', 'groupId': 'OG003', 'lowerLimit': '0.13', 'upperLimit': '0.26'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and week 2', 'description': 'FEF 25-75- Forced expiratory flow over the middle one half of the FVC. The results are expressed as the change from baseline', 'unitOfMeasure': 'Liters/seconds', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS). The FAS was defined as all randomised patients who contributed data from at least one period (ie data from both low and high dose of one inhaler).'}, {'type': 'SECONDARY', 'title': 'eNO (Exhaled Nitrogen Oxide)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Budesonide Hydrofluoroalkane(HFA) 100', 'description': 'Budesonide Hydrofluoroalkane(HFA) 100 mcg twice daily for 2 weeks'}, {'id': 'OG001', 'title': 'Budesonide HFA 400', 'description': 'Budesonide HFA 400 mcg twice daily for 2 weeks'}, {'id': 'OG002', 'title': 'Budesonide Chlorofluorocarbon (CFC) 100', 'description': 'Budesonide Chlorofluorocarbon (CFC) 100 mcg twice daily for 2 weeks'}, {'id': 'OG003', 'title': 'Budesonide CFC 400', 'description': 'Budesonide CFC 400 mcg twice daily for 2 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.66', 'groupId': 'OG000', 'lowerLimit': '0.62', 'upperLimit': '0.70'}, {'value': '0.57', 'groupId': 'OG001', 'lowerLimit': '0.53', 'upperLimit': '0.60'}, {'value': '0.66', 'groupId': 'OG002', 'lowerLimit': '0.63', 'upperLimit': '0.70'}, {'value': '0.59', 'groupId': 'OG003', 'lowerLimit': '0.55', 'upperLimit': '0.62'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'baseline and week 2', 'description': 'eNO ratio of baseline', 'unitOfMeasure': 'Ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS). The FAS was defined as all randomised patients who contributed data from at least one period (ie data from both low and high dose of one inhaler).'}, {'type': 'SECONDARY', 'title': 'Asthma Symptom Score Morning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Budesonide Hydrofluoroalkane(HFA) 100', 'description': 'Budesonide Hydrofluoroalkane(HFA) 100 mcg twice daily for 2 weeks'}, {'id': 'OG001', 'title': 'Budesonide HFA 400', 'description': 'Budesonide HFA 400 mcg twice daily for 2 weeks'}, {'id': 'OG002', 'title': 'Budesonide Chlorofluorocarbon(CFC) 100', 'description': 'Budesonide Chlorofluorocarbon (CFC) 100 mcg twice daily for 2 weeks'}, {'id': 'OG003', 'title': 'Budesonide CFC 400', 'description': 'Budesonide CFC 400 mcg twice daily for 2 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.39', 'groupId': 'OG000', 'lowerLimit': '0.34', 'upperLimit': '0.44'}, {'value': '0.29', 'groupId': 'OG001', 'lowerLimit': '0.24', 'upperLimit': '0.34'}, {'value': '0.39', 'groupId': 'OG002', 'lowerLimit': '0.34', 'upperLimit': '0.44'}, {'value': '0.30', 'groupId': 'OG003', 'lowerLimit': '0.25', 'upperLimit': '0.35'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '2 weeks', 'description': 'Asthma Symptom score recorded daily in the morning: Scale: 0-3. 0 = None; no asthma symptoms. 1 = Mild symptoms; aware of asthma symptoms but easily tolerated. 2 = Moderate symptoms; asthma causing enough discomfort to cause problems with normal activities (or with sleep). 3 =Severe symptoms; unable to do normal activities. The average of means for values recorded daily in the morning is presented.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS). The FAS was defined as all randomised patients who contributed data from at least one period (ie data from both low and high dose of one inhaler).'}, {'type': 'SECONDARY', 'title': 'Asthma Symptom Score Evening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Budesonide Hydrofluoroalkane(HFA) 100', 'description': 'Budesonide Hydrofluoroalkane (HFA) 100 mcg twice daily for 2 weeks'}, {'id': 'OG001', 'title': 'Budesonide HFA 400', 'description': 'Budesonide HFA 400 mcg twice daily for 2 weeks'}, {'id': 'OG002', 'title': 'Budesonide Chlorofluorocarbon (CFC) 100', 'description': 'Budesonide Chlorofluorocarbon (CFC) 100 mcg twice daily for 2 weeks'}, {'id': 'OG003', 'title': 'Budesonide CFC 400', 'description': 'Budesonide CFC 400 mcg twice daily for 2 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.48', 'groupId': 'OG000', 'lowerLimit': '0.43', 'upperLimit': '0.52'}, {'value': '0.32', 'groupId': 'OG001', 'lowerLimit': '0.27', 'upperLimit': '0.38'}, {'value': '0.46', 'groupId': 'OG002', 'lowerLimit': '0.41', 'upperLimit': '0.50'}, {'value': '0.36', 'groupId': 'OG003', 'lowerLimit': '0.31', 'upperLimit': '0.41'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '2 weeks', 'description': 'Asthma Symptom score recorded daily in the evening: Scale: 0-3. 0 = None; no asthma symptoms. 1 = Mild symptoms; aware of asthma symptoms but easily tolerated. 2 = Moderate symptoms; asthma causing enough discomfort to cause problems with normal activities (or with sleep). 3 =Severe symptoms; unable to do normal activities. The average of means for values recorded daily in the evening is presented.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS). The FAS was defined as all randomised patients who contributed data from at least one period (ie data from both low and high dose of one inhaler).'}, {'type': 'SECONDARY', 'title': 'Asthma Symptom Score Total', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Budesonide Hydrofluoroalkane(HFA) 100', 'description': 'Budesonide Hydrofluoroalkane (HFA) 100 mcg twice daily for 2 weeks'}, {'id': 'OG001', 'title': 'Budesonide HFA 400', 'description': 'Budesonide HFA 400 mcg twice daily for 2 weeks'}, {'id': 'OG002', 'title': 'Budesonide Chlorofluorocarbon (CFC) 100', 'description': 'Budesonide Chlorofluorocarbon (CFC) 100 mcg twice daily for 2 weeks'}, {'id': 'OG003', 'title': 'Budesonide CFC 400', 'description': 'Budesonide CFC 400 mcg twice daily for 2 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.87', 'groupId': 'OG000', 'lowerLimit': '0.78', 'upperLimit': '0.96'}, {'value': '0.61', 'groupId': 'OG001', 'lowerLimit': '0.52', 'upperLimit': '0.71'}, {'value': '0.85', 'groupId': 'OG002', 'lowerLimit': '0.76', 'upperLimit': '0.94'}, {'value': '0.66', 'groupId': 'OG003', 'lowerLimit': '0.56', 'upperLimit': '0.76'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '2 weeks', 'description': 'Asthma Symptom score recoded daily, Total. Scale: 0 - 3. 0 = None; no asthma symptoms. 1 = Mild symptoms; aware of asthma symptoms but easily tolerated. 2 = Moderate symptoms; asthma causing enough discomfort to cause problems with normal activities (or with sleep). 3 =Severe symptoms; unable to do normal activities. The average of means for values recorded daily is presented.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS). The FAS was defined as all randomised patients who contributed data from at least one period (ie data from both low and high dose of one inhaler).'}, {'type': 'SECONDARY', 'title': 'Rescue Medication Morning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Budesonide Hydrofluoroalkane (HFA) 100', 'description': 'Budesonide Hydrofluoroalkane(HFA) 100 mcg twice daily for 2 weeks'}, {'id': 'OG001', 'title': 'Budesonide HFA 400', 'description': 'Budesonide HFA 400 mcg twice daily for 2 weeks'}, {'id': 'OG002', 'title': 'Budesonide Chlorofluorocarbon (CFC) 100', 'description': 'Budesonide Chlorofluorocarbon (CFC) 100 mcg twice daily for 2 weeks'}, {'id': 'OG003', 'title': 'Budesonide CFC 400', 'description': 'Budesonide CFC 400 mcg twice daily for 2 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.71', 'groupId': 'OG000', 'lowerLimit': '0.60', 'upperLimit': '0.82'}, {'value': '0.45', 'groupId': 'OG001', 'lowerLimit': '0.34', 'upperLimit': '0.56'}, {'value': '0.62', 'groupId': 'OG002', 'lowerLimit': '0.51', 'upperLimit': '0.73'}, {'value': '0.50', 'groupId': 'OG003', 'lowerLimit': '0.39', 'upperLimit': '0.61'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '2 weeks', 'description': 'The average of means for inhalations of rescue medication in the morning is presented.', 'unitOfMeasure': 'Number of inhalations', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS). The FAS was defined as all randomised patients who contributed data from at least one period (ie data from both low and high dose of one inhaler).'}, {'type': 'SECONDARY', 'title': 'Rescue Medication Evening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Budesonide Hydrofluoroalkane(HFA) 100', 'description': 'Budesonide Hydrofluoroalkane(HFA) 100 mcg twice daily for 2 weeks'}, {'id': 'OG001', 'title': 'Budesonide HFA 400', 'description': 'Budesonide HFA 400 mcg twice daily for 2 weeks'}, {'id': 'OG002', 'title': 'Budesonide Chlorofluorocarbon (CFC) 100', 'description': 'Budesonide Chlorofluorocarbon(CFC) 100 mcg twice daily for 2 weeks'}, {'id': 'OG003', 'title': 'Budesonide CFC 400', 'description': 'Budesonide CFC 400 mcg twice daily for 2 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.90', 'groupId': 'OG000', 'lowerLimit': '0.77', 'upperLimit': '1.03'}, {'value': '0.67', 'groupId': 'OG001', 'lowerLimit': '0.52', 'upperLimit': '0.80'}, {'value': '0.84', 'groupId': 'OG002', 'lowerLimit': '0.71', 'upperLimit': '0.97'}, {'value': '0.64', 'groupId': 'OG003', 'lowerLimit': '0.50', 'upperLimit': '0.78'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '2 weeks', 'description': 'The average of means for inhalations of rescue medication in the evening is presented.', 'unitOfMeasure': 'Number of inhalations', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS). The FAS was defined as all randomised patients who contributed data from at least one period (ie data from both low and high dose of one inhaler).'}, {'type': 'SECONDARY', 'title': 'Rescue Medication Total', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Budesonide Hydrofluoroalkane (HFA) 100', 'description': 'Budesonide Hydrofluoroalkane(HFA) 100 mcg twice daily for 2 weeks'}, {'id': 'OG001', 'title': 'Budesonide HFA 400', 'description': 'Budesonide HFA 400 mcg twice daily for 2 weeks'}, {'id': 'OG002', 'title': 'Budesonide Chlorofluorocarbon(CFC) 100', 'description': 'Budesonide Chlorofluorocarbon (CFC) 100 mcg twice daily for 2 weeks'}, {'id': 'OG003', 'title': 'Budesonide CFC 400', 'description': 'Budesonide CFC 400 mcg twice daily for 2 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '1.58', 'groupId': 'OG000', 'lowerLimit': '1.35', 'upperLimit': '1.80'}, {'value': '1.10', 'groupId': 'OG001', 'lowerLimit': '0.86', 'upperLimit': '1.33'}, {'value': '1.39', 'groupId': 'OG002', 'lowerLimit': '1.16', 'upperLimit': '1.62'}, {'value': '1.05', 'groupId': 'OG003', 'lowerLimit': '0.81', 'upperLimit': '1.29'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '2 weeks', 'description': 'The average of means for inhalations of rescue medication in morning and evening combined over a 24 hour period is presented.', 'unitOfMeasure': 'Number of inhalations/24 hours', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS). The FAS was defined as all randomised patients who contributed data from at least one period (ie data from both low and high dose of one inhaler).'}, {'type': 'SECONDARY', 'title': 'Peak Exploratory Flow (PEF) Morning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Budesonide Hydrofluoroalkane (HFA) 100', 'description': 'Budesonide Hydrofluoroalkane(HFA) 100 mcg twice daily for 2 weeks'}, {'id': 'OG001', 'title': 'Budesonide HFA 400', 'description': 'Budesonide HFA 400 mcg twice daily for 2 weeks'}, {'id': 'OG002', 'title': 'Budesonide Chlorofluorocarbon (CFC) 100', 'description': 'Budesonide Chlorofluorocarbon (CFC) 100 mcg twice daily for 2 weeks'}, {'id': 'OG003', 'title': 'Budesonide CFC 400', 'description': 'Budesonide CFC 400 mcg twice daily for 2 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '426', 'groupId': 'OG000', 'lowerLimit': '421', 'upperLimit': '431'}, {'value': '437', 'groupId': 'OG001', 'lowerLimit': '433', 'upperLimit': '442'}, {'value': '428', 'groupId': 'OG002', 'lowerLimit': '424', 'upperLimit': '433'}, {'value': '438', 'groupId': 'OG003', 'lowerLimit': '433', 'upperLimit': '442'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '2 weeks', 'description': 'Peak Exploratory Flow (PEF) recorded daily in the morning', 'unitOfMeasure': 'Liters/minutes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS). The FAS was defined as all randomised patients who contributed data from at least one period (ie data from both low and high dose of one inhaler).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Budesonide Hydrofluoroalkane (HFA) First, Then Budesonide CFC', 'description': 'Budesonide Hydrofluoroalkane (HFA), 100 mcg twice daily followed by Budesonide HFA 400 mcg twice daily First, Wash out, then Budesonide Chlorofluorocarbon (CFC) 100 mcg twice daily followed by Budesonide CFC 400 mcg twice daily.'}, {'id': 'FG001', 'title': 'Budesonide Chlorofluorocarbon (CFC) First, Then Budesonide HFA', 'description': 'Budesonide CFC, 100 mcg twice daily followed by Budesonide CFC 400 mcg twice daily First, Wash out, then Budesonide HFA 100 mcg twice daily followed by 400 mcg twice daily.'}], 'periods': [{'title': 'First Intervention 100 Mcg Twice Daily', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '45'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Condition Under Investigation Worsened', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Second Intervention 400 Mcg Twice Daily', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '45'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '41'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Condition Under Investigation Worsened', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Medication not allowed taken', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Wash-out', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '41'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '36'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Not within one doubling dilution', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Failure to wash-out', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Third Intervention 100 Mcg Twice Daily', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '36'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '35'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Forth Intervention 400 Mcg Twice Daily', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '35'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '35'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '144 were enrolled, 45 were excluded: 11 for eligibility not fulfilled, 8 with condition under investigation worsened, 8 for voluntary withdrawal, 17 with reasons not specified, and 1 lost to follow-up and 99 were randomised.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Budesonide Hydrofluoroalkane (HFA) First, Then Budesonide CFC', 'description': 'Budesonide Hydrofluoroalkane (HFA), 100 mcg twice daily followed by Budesonide HFA 400 mcg twice daily, First then Budesonide Chlorofluorocarbon (CFC) 100 mcg twice daily followed by Budesonide CFC 400 mcg twice daily.'}, {'id': 'BG001', 'title': 'Budesonide Chlorofluorocarbon (CFC) First, Then Budesonide HFA', 'description': 'Budesonide CFC, 100 mcg twice daily followed by Budesonide CFC 400 mcg twice daily First, then Budesonide HFA 100 mcg twice daily followed by 400 mcg twice daily.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '40.0', 'groupId': 'BG000', 'lowerLimit': '19.0', 'upperLimit': '65.0'}, {'value': '39.5', 'groupId': 'BG001', 'lowerLimit': '18.0', 'upperLimit': '64.0'}, {'value': '39.75', 'groupId': 'BG002', 'lowerLimit': '18.0', 'upperLimit': '65.0'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 99}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-10-09', 'studyFirstSubmitDate': '2008-04-23', 'resultsFirstSubmitDate': '2010-05-12', 'studyFirstSubmitQcDate': '2008-04-27', 'lastUpdatePostDateStruct': {'date': '2012-11-07', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-10-09', 'studyFirstPostDateStruct': {'date': '2008-04-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-11-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PC 20 Methacholine (Provocative Concentration of Methacholine Causing 20 % Fall in FEV1(Forced Expiratory Volume)', 'timeFrame': 'Baseline and week 2', 'description': 'Provocative concentration of methacholine is that causing a 20% fall in FEV1. The methacholine challenge test entailed the patient inhaling from an aerosol containing doubling concentrations of methacholine over a period of 2 minutes until FEV1 had been reduced by 20%.\n\nThe ratio of Methacholine concentration measured at 2 weeks to that at Baseline.'}], 'secondaryOutcomes': [{'measure': 'Peak Exploratory Flow (PEF)', 'timeFrame': 'Baseline to week 2 recorded daily', 'description': 'Change in PEF at Week 2 from baseline, mean over all days in run-in and all dasy in treatment period, with baseline as covariate.'}, {'measure': 'FEV1 (Forced Expiratory Volume in 1 Second)', 'timeFrame': 'Baseline to week 2', 'description': 'FEV1 change from baseline'}, {'measure': 'FEF 25-75 (Forced Expiratory Flow 25-75)', 'timeFrame': 'Baseline and week 2', 'description': 'FEF 25-75- Forced expiratory flow over the middle one half of the FVC. The results are expressed as the change from baseline'}, {'measure': 'eNO (Exhaled Nitrogen Oxide)', 'timeFrame': 'baseline and week 2', 'description': 'eNO ratio of baseline'}, {'measure': 'Asthma Symptom Score Morning', 'timeFrame': '2 weeks', 'description': 'Asthma Symptom score recorded daily in the morning: Scale: 0-3. 0 = None; no asthma symptoms. 1 = Mild symptoms; aware of asthma symptoms but easily tolerated. 2 = Moderate symptoms; asthma causing enough discomfort to cause problems with normal activities (or with sleep). 3 =Severe symptoms; unable to do normal activities. The average of means for values recorded daily in the morning is presented.'}, {'measure': 'Asthma Symptom Score Evening', 'timeFrame': '2 weeks', 'description': 'Asthma Symptom score recorded daily in the evening: Scale: 0-3. 0 = None; no asthma symptoms. 1 = Mild symptoms; aware of asthma symptoms but easily tolerated. 2 = Moderate symptoms; asthma causing enough discomfort to cause problems with normal activities (or with sleep). 3 =Severe symptoms; unable to do normal activities. The average of means for values recorded daily in the evening is presented.'}, {'measure': 'Asthma Symptom Score Total', 'timeFrame': '2 weeks', 'description': 'Asthma Symptom score recoded daily, Total. Scale: 0 - 3. 0 = None; no asthma symptoms. 1 = Mild symptoms; aware of asthma symptoms but easily tolerated. 2 = Moderate symptoms; asthma causing enough discomfort to cause problems with normal activities (or with sleep). 3 =Severe symptoms; unable to do normal activities. The average of means for values recorded daily is presented.'}, {'measure': 'Rescue Medication Morning', 'timeFrame': '2 weeks', 'description': 'The average of means for inhalations of rescue medication in the morning is presented.'}, {'measure': 'Rescue Medication Evening', 'timeFrame': '2 weeks', 'description': 'The average of means for inhalations of rescue medication in the evening is presented.'}, {'measure': 'Rescue Medication Total', 'timeFrame': '2 weeks', 'description': 'The average of means for inhalations of rescue medication in morning and evening combined over a 24 hour period is presented.'}, {'measure': 'Peak Exploratory Flow (PEF) Morning', 'timeFrame': '2 weeks', 'description': 'Peak Exploratory Flow (PEF) recorded daily in the morning'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Asthma hyperreactivity'], 'conditions': ['Asthma']}, 'referencesModule': {'references': [{'pmid': '28065396', 'type': 'DERIVED', 'citation': 'Anderson WJ, Short PM, Jabbal S, Lipworth BJ. Inhaled corticosteroid dose response in asthma: Should we measure inflammation? Ann Allergy Asthma Immunol. 2017 Feb;118(2):179-185. doi: 10.1016/j.anai.2016.11.018. Epub 2017 Jan 3.'}]}, 'descriptionModule': {'briefSummary': 'This study is being carried out to see if budesonide with HFA is effective, safe and well tolerated compared with budesonide CFC. Budesonide HFA has been already given in other research studies, in both healthy volunteers and subjects with asthma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients suffering from stable, persistent, mild to moderate asthma as defined by Global Initiative for Asthma (GINA) Guidelines and for whom FEV1 \\> 60 %\n* ICS taking ≤ 1000 μg BDP per day, or equivalent\n* Methacholine PC20 \\< 4 mg/mL\n\nExclusion Criteria:\n\n* Known or suspected hypersensitivity to budesonide or any other constituents of the budesonide HFA pMDI or budesonide CFC pMDI.\n* Currently a smoker or who has ceased smoking within 6 months of Visit 1.\n* Exacerbations of asthma requiring oral steroids, hospitalisation or change in asthma therapy in the previous three months.\n* Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) or bronchiectasis'}, 'identificationModule': {'nctId': 'NCT00667992', 'briefTitle': 'Study Comparing Budesonide Hydrofluoroalkane (HFA) vs Chlorofluorocarbon (CFC) Pressurized Metered Dose Inhalers (pMDI) in Patients With Mild to Moderate Asthma', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Phase 3, Randomised, Open-label, Crossover Study to Compare HFA vs CFC pMDI Formulations of Budesonide on Methacholine Hyper-reactivity in Patients With Stable, Persistent, Mild to Moderate Asthma', 'orgStudyIdInfo': {'id': 'D5252C00008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Budesonide Hydrofluoroalkane (HFA) 100', 'description': 'Budesonide Hydrofluoroalkane (HFA) 100 mcg twice daily for 2 weeks', 'interventionNames': ['Drug: Budesonide HFA']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Budesonide HFA 400', 'description': 'Budesonide HFA 400 mcg twice daily for 2 weeks', 'interventionNames': ['Drug: Budesonide HFA']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Budesonide Chlorofluorocarbon (CFC) 100', 'description': 'Budesonide Chlorofluorocarbon(CFC) 100 mcg twice daily for 2 weeks', 'interventionNames': ['Drug: Budesonide CFC']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Budesonide CFC 400', 'description': 'Budesonide CFC 400 mcg twice daily for 2 weeks', 'interventionNames': ['Drug: Budesonide CFC']}], 'interventions': [{'name': 'Budesonide HFA', 'type': 'DRUG', 'description': 'standard daily inhaled dose', 'armGroupLabels': ['Budesonide HFA 400', 'Budesonide Hydrofluoroalkane (HFA) 100']}, {'name': 'Budesonide CFC', 'type': 'DRUG', 'description': 'standard daily inhaled dose', 'armGroupLabels': ['Budesonide CFC 400', 'Budesonide Chlorofluorocarbon (CFC) 100']}]}, 'contactsLocationsModule': {'locations': [{'city': 'King of Prussia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 40.08927, 'lon': -75.39602}}, {'city': 'Dundee', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 56.46913, 'lon': -2.97489}}, {'city': 'Perth', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 56.39522, 'lon': -3.43139}}], 'overallOfficials': [{'name': 'Brian Lipworth, PhD, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asthma and Allergy Research Group Division of Medicine and Therapeutics Ninewells Hospital and Medical School University of Dundee'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}