Ignite Creation Date:
2025-12-24 @ 9:27 PM
Ignite Modification Date:
2026-02-23 @ 11:35 AM
Study NCT ID:
NCT02170532
Status:
COMPLETED
Last Update Posted:
2014-08-13
First Post:
2014-06-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Aerosolized Beta-Agonist Isomers in 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D064412', 'term': 'Levalbuterol'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D000420', 'term': 'Albuterol'}, {'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'macin001@mc.duke.edu', 'phone': '(919) 681-2720', 'title': 'Neil MacIntyre, MD', 'organization': 'Duke University Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'All Subjects', 'description': 'All subjects will receive all 5 treatments on 5 different treatment days. Each subject will receive all 5 treatments in the same order.', 'otherNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Maximum Forced Expiratory Volume at One Second (FEV1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Levalbuterol + Saline in a Breath Actuated Nebulizer', 'description': '0.5 ml. levalbuterol + 0.5ml saline in a breath actuated nebulizer\n\nlevalbuterol: 0.5 ml. levalbuterol\n\nsaline: 0.5ml saline\n\nbreath actuated nebulizer'}, {'id': 'OG001', 'title': 'Levalbuterol + Ipratroprium in a Breath Actuated Nebulizer', 'description': '0.5 ml. levalbuterol + 0.5ml ipratroprium in a breath actuated nebulizer\n\nlevalbuterol: 0.5 ml. levalbuterol\n\nbreath actuated nebulizer\n\nipratroprium'}, {'id': 'OG002', 'title': 'Levalbuterol Metered Dose Inhaler (MDI) 2 Puffs', 'description': 'levalbuterol metered dose inhaler (MDI) 2 puffs\n\nlevalbuterol MDI'}, {'id': 'OG003', 'title': 'Levalbuterol MDI + Aerochamber Max Without Pause 2 Puffs', 'description': 'levalbuterol metered-dose inhaler (MDI) + aerochamber max without pause 2 puffs\n\nlevalbuterol MDI\n\naerochamber max'}, {'id': 'OG004', 'title': 'Levalbuterol MDI + Aerochamber Max With 2 Second Pause 2 Puffs', 'description': 'levalbuterol metered dose inhaler (MDI) + aerochamber max with 2 second pause 2 puffs\n\nlevalbuterol MDI\n\naerochamber max'}], 'classes': [{'title': '30 minutes', 'categories': [{'measurements': [{'value': '20', 'spread': '23.19', 'groupId': 'OG000'}, {'value': '20', 'spread': '16.55', 'groupId': 'OG001'}, {'value': '20', 'spread': '19.85', 'groupId': 'OG002'}, {'value': '19', 'spread': '20.64', 'groupId': 'OG003'}, {'value': '21', 'spread': '21.10', 'groupId': 'OG004'}]}]}, {'title': '1 hour', 'categories': [{'measurements': [{'value': '28', 'spread': '31.45', 'groupId': 'OG000'}, {'value': '23', 'spread': '19.24', 'groupId': 'OG001'}, {'value': '19', 'spread': '22.57', 'groupId': 'OG002'}, {'value': '20', 'spread': '24.23', 'groupId': 'OG003'}, {'value': '24', 'spread': '22.62', 'groupId': 'OG004'}]}]}, {'title': '2 hour', 'categories': [{'measurements': [{'value': '26', 'spread': '32.23', 'groupId': 'OG000'}, {'value': '22', 'spread': '20.64', 'groupId': 'OG001'}, {'value': '20', 'spread': '23.02', 'groupId': 'OG002'}, {'value': '19', 'spread': '26.25', 'groupId': 'OG003'}, {'value': '19', 'spread': '21.47', 'groupId': 'OG004'}]}]}, {'title': '4 hour', 'categories': [{'measurements': [{'value': '15', 'spread': '29.05', 'groupId': 'OG000'}, {'value': '14', 'spread': '18.89', 'groupId': 'OG001'}, {'value': '7', 'spread': '18.99', 'groupId': 'OG002'}, {'value': '6', 'spread': '16.88', 'groupId': 'OG003'}, {'value': '7', 'spread': '18.51', 'groupId': 'OG004'}]}]}, {'title': '6 hour', 'categories': [{'measurements': [{'value': '0', 'spread': '18.9', 'groupId': 'OG000'}, {'value': '1', 'spread': '5.23', 'groupId': 'OG001'}, {'value': '-5', 'spread': '5.98', 'groupId': 'OG002'}, {'value': '1', 'spread': '16.05', 'groupId': 'OG003'}, {'value': '-6', 'spread': '11.68', 'groupId': 'OG004'}]}]}, {'title': '8 hour', 'categories': [{'measurements': [{'value': '1', 'spread': '21.26', 'groupId': 'OG000'}, {'value': '9', 'spread': '13.10', 'groupId': 'OG001'}, {'value': '-3', 'spread': '7.91', 'groupId': 'OG002'}, {'value': '0', 'spread': '15.54', 'groupId': 'OG003'}, {'value': '-6', 'spread': '11.55', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (before treatment), 30 minutes, 1, 2, 4, 6, and 8 hours post treatment', 'unitOfMeasure': 'percentage of change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The same 10 subjects received each of the 5 treatments in the same order. Subjects 1-5 were not included in 6 and 8 hour time points.'}, {'type': 'SECONDARY', 'title': 'Change in 8 Hour Area-under-the-curve FEV1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Levalbuterol + Saline in a Breath Actuated Nebulizer', 'description': '0.5 ml. levalbuterol + 0.5ml saline in a breath actuated nebulizer\n\nlevalbuterol: 0.5 ml. levalbuterol\n\nsaline: 0.5ml saline\n\nbreath actuated nebulizer'}, {'id': 'OG001', 'title': 'Levalbuterol + Ipratroprium in a Breath Actuated Nebulizer', 'description': '0.5 ml. levalbuterol + 0.5ml ipratroprium in a breath actuated nebulizer\n\nlevalbuterol: 0.5 ml. levalbuterol\n\nbreath actuated nebulizer\n\nipratroprium'}, {'id': 'OG002', 'title': 'Levalbuterol MDI 2 Puffs', 'description': 'levalbuterol metered dose inhaler 2 puffs\n\nlevalbuterol MDI'}, {'id': 'OG003', 'title': 'Levalbuterol MDI + Aerochamber Max Without Pause 2 Puffs', 'description': 'levalbuterol MDI + aerochamber max without pause 2 puffs\n\nlevalbuterol MDI\n\naerochamber max'}, {'id': 'OG004', 'title': 'Levalbuterol MDI + Aerochamber Max With 2 Second Pause 2 Puffs', 'description': 'levalbuterol MDI + aerochamber max with 2 second pause 2 puffs\n\nlevalbuterol MDI\n\naerochamber max'}], 'classes': [{'categories': [{'measurements': [{'value': '5450', 'spread': '7039', 'groupId': 'OG000'}, {'value': '4729', 'spread': '4275', 'groupId': 'OG001'}, {'value': '3893', 'spread': '4949', 'groupId': 'OG002'}, {'value': '3805', 'spread': '5253', 'groupId': 'OG003'}, {'value': '4195', 'spread': '4795', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 to 8 hours post dose', 'unitOfMeasure': 'percentage of change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Heart Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Levalbuterol + Saline in a Breath Actuated Nebulizer', 'description': '0.5 ml. levalbuterol + 0.5ml saline in a breath actuated nebulizer\n\nlevalbuterol: 0.5 ml. levalbuterol\n\nsaline: 0.5ml saline\n\nbreath actuated nebulizer'}, {'id': 'OG001', 'title': 'Levalbuterol + Ipratroprium in a Breath Actuated Nebulizer', 'description': '0.5 ml. levalbuterol + 0.5ml ipratroprium in a breath actuated nebulizer\n\nlevalbuterol: 0.5 ml. levalbuterol\n\nbreath actuated nebulizer\n\nipratroprium'}, {'id': 'OG002', 'title': 'Levalbuterol MDI 2 Puffs', 'description': 'levalbuterol metered dose inhaler 2 puffs\n\nlevalbuterol MDI'}, {'id': 'OG003', 'title': 'Levalbuterol MDI + Aerochamber Max Without Pause 2 Puffs', 'description': 'levalbuterol MDI + aerochamber max without pause 2 puffs\n\nlevalbuterol MDI\n\naerochamber max'}, {'id': 'OG004', 'title': 'Levalbuterol MDI + Aerochamber Max With 2 Second Pause 2 Puffs', 'description': 'levalbuterol MDI + aerochamber max with 2 second pause 2 puffs\n\nlevalbuterol MDI\n\naerochamber max'}], 'timeFrame': 'Baseline (before treatment), 30 minutes, 1, 2, 4, 6, and 8 hours post treatment', 'reportingStatus': 'POSTED', 'populationDescription': 'Data for this outcome measure is not reported because the data was not collected.'}, {'type': 'SECONDARY', 'title': 'Change in Tremor Assessment Measured by a Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Levalbuterol + Saline in a Breath Actuated Nebulizer', 'description': '0.5 ml. levalbuterol + 0.5ml saline in a breath actuated nebulizer\n\nlevalbuterol: 0.5 ml. levalbuterol\n\nsaline: 0.5ml saline\n\nbreath actuated nebulizer'}, {'id': 'OG001', 'title': 'Levalbuterol + Ipratroprium in a Breath Actuated Nebulizer', 'description': '0.5 ml. levalbuterol + 0.5ml ipratroprium in a breath actuated nebulizer\n\nlevalbuterol: 0.5 ml. levalbuterol\n\nbreath actuated nebulizer\n\nipratroprium'}, {'id': 'OG002', 'title': 'Levalbuterol MDI 2 Puffs', 'description': 'levalbuterol metered dose inhaler 2 puffs\n\nlevalbuterol MDI'}, {'id': 'OG003', 'title': 'Levalbuterol MDI + Aerochamber Max Without Pause 2 Puffs', 'description': 'levalbuterol MDI + aerochamber max without pause 2 puffs\n\nlevalbuterol MDI\n\naerochamber max'}, {'id': 'OG004', 'title': 'Levalbuterol MDI + Aerochamber Max With 2 Second Pause 2 Puffs', 'description': 'levalbuterol MDI + aerochamber max with 2 second pause 2 puffs\n\nlevalbuterol MDI\n\naerochamber max'}], 'timeFrame': 'Baseline (before treatment), 30 minutes, 1, 2, 4, 6, and 8 hours post treatment', 'description': 'Tremor assessment will be made on outstretched hands (0 = none, 1+ = fine tremor, barely perceptible, 2+ = obvious tremor).', 'reportingStatus': 'POSTED', 'populationDescription': 'Data for this outcome measure is not reported because the data was not collected.'}, {'type': 'SECONDARY', 'title': 'Change in Dyspnea Response as Measured by the University of California, San Diego (UCSD) Dyspnea Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Levalbuterol + Saline in a Breath Actuated Nebulizer', 'description': '0.5 ml. levalbuterol + 0.5ml saline in a breath actuated nebulizer\n\nlevalbuterol: 0.5 ml. levalbuterol\n\nsaline: 0.5ml saline\n\nbreath actuated nebulizer'}, {'id': 'OG001', 'title': 'Levalbuterol + Ipratroprium in a Breath Actuated Nebulizer', 'description': '0.5 ml. levalbuterol + 0.5ml ipratroprium in a breath actuated nebulizer\n\nlevalbuterol: 0.5 ml. levalbuterol\n\nbreath actuated nebulizer\n\nipratroprium'}, {'id': 'OG002', 'title': 'Levalbuterol MDI 2 Puffs', 'description': 'levalbuterol metered dose inhaler 2 puffs\n\nlevalbuterol MDI'}, {'id': 'OG003', 'title': 'Levalbuterol MDI + Aerochamber Max Without Pause 2 Puffs', 'description': 'levalbuterol MDI + aerochamber max without pause 2 puffs\n\nlevalbuterol MDI\n\naerochamber max'}, {'id': 'OG004', 'title': 'Levalbuterol MDI + Aerochamber Max With 2 Second Pause 2 Puffs', 'description': 'levalbuterol MDI + aerochamber max with 2 second pause 2 puffs\n\nlevalbuterol MDI\n\naerochamber max'}], 'timeFrame': 'Baseline (before treatment), 30 minutes, 1, 2, 4, 6, and 8 hours post treatment', 'reportingStatus': 'POSTED', 'populationDescription': 'Data for this outcome measure is not reported because the data was not collected.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Subjects', 'description': 'All subjects will receive all 5 treatments on 5 different treatment days. Each subject will receive all 5 treatments in the same order.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Subjects', 'description': 'All subjects will receive all 5 treatments on 5 different treatment days. Each subject will receive all 5 treatments in the same order.'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '18 & older', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'All subjects will receive all 5 treatments on 5 different treatment days. Each subject will receive all 5 treatments in the same order.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-11', 'studyFirstSubmitDate': '2014-06-19', 'resultsFirstSubmitDate': '2014-07-10', 'studyFirstSubmitQcDate': '2014-06-19', 'lastUpdatePostDateStruct': {'date': '2014-08-13', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-07-10', 'studyFirstPostDateStruct': {'date': '2014-06-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-08-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Maximum Forced Expiratory Volume at One Second (FEV1)', 'timeFrame': 'Baseline (before treatment), 30 minutes, 1, 2, 4, 6, and 8 hours post treatment'}], 'secondaryOutcomes': [{'measure': 'Change in 8 Hour Area-under-the-curve FEV1', 'timeFrame': '0 to 8 hours post dose'}, {'measure': 'Change in Heart Rate', 'timeFrame': 'Baseline (before treatment), 30 minutes, 1, 2, 4, 6, and 8 hours post treatment'}, {'measure': 'Change in Tremor Assessment Measured by a Scale', 'timeFrame': 'Baseline (before treatment), 30 minutes, 1, 2, 4, 6, and 8 hours post treatment', 'description': 'Tremor assessment will be made on outstretched hands (0 = none, 1+ = fine tremor, barely perceptible, 2+ = obvious tremor).'}, {'measure': 'Change in Dyspnea Response as Measured by the University of California, San Diego (UCSD) Dyspnea Scale', 'timeFrame': 'Baseline (before treatment), 30 minutes, 1, 2, 4, 6, and 8 hours post treatment'}]}, 'conditionsModule': {'keywords': ['asthma'], 'conditions': ['Asthma']}, 'descriptionModule': {'briefSummary': 'Dr. MacIntyre and his colleagues are studying inhaled medications in asthma. There are two new medications that have been approved by the United States Food and Drug Administration (FDA): levalbuterol and formoterol. Both of these drugs are similar to standard asthma bronchodilator drugs but offer theoretical advantages in terms of fewer side effects. There are also newer devices to deliver these medications into the lungs: breath actuated nebulizers (BANs) and non-static chambers (Aerochamber-max) that can be used with metered dose inhalers (MDIs or "puffers"). The purpose of this study is to deliver these new medications using several different devices and measuring lung function, heart rate, and sensations of breathlessness.', 'detailedDescription': 'Patients will be studied on five separate mornings. The duration of the study and frequency of the visits will be solely dependant on the subject availability. Each subject will receive all 5 treatments in the same order.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* stable mild to moderate persistent asthma as defined by the National Asthma Education and Prevention Program\n* greater than 18 years of age\n* requiring bronchodilator therapy either routinely or on a as needed (PRN)basis\n* stable with respect to respiratory disease and at least four weeks removed from the most recent acute exacerbation of the disease\n* patients may or may not be on inhaled corticosteroids\n\nExclusion Criteria:\n\n* no unstable cardiovascular symptoms\n* no unstable angina\n* must be at least four weeks removed from an acute coronary syndrome'}, 'identificationModule': {'nctId': 'NCT02170532', 'briefTitle': 'Aerosolized Beta-Agonist Isomers in Asthma', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Aerosolized Beta-Agonist Isomers in Asthma', 'orgStudyIdInfo': {'id': 'Pro00013822'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'levalbuterol + saline in a breath actuated nebulizer', 'description': '0.5 ml. levalbuterol + 0.5ml saline in a breath actuated nebulizer', 'interventionNames': ['Drug: levalbuterol', 'Drug: saline', 'Device: breath actuated nebulizer']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'levalbuterol + ipratroprium in a breath actuated nebulizer', 'description': '0.5 ml. levalbuterol + 0.5ml ipratroprium in a breath actuated nebulizer', 'interventionNames': ['Drug: levalbuterol', 'Device: breath actuated nebulizer', 'Drug: ipratroprium']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'levalbuterol MDI 2 puffs', 'description': 'levalbuterol metered dose inhaler 2 puffs', 'interventionNames': ['Other: levalbuterol MDI']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'levalbuterol MDI + aerochamber max without pause 2 puffs', 'description': 'levalbuterol MDI + aerochamber max without pause 2 puffs', 'interventionNames': ['Other: levalbuterol MDI', 'Device: aerochamber max']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'levalbuterol MDI + aerochamber max with 2 second pause 2 puffs', 'description': 'levalbuterol MDI + aerochamber max with 2 second pause 2 puffs', 'interventionNames': ['Other: levalbuterol MDI', 'Device: aerochamber max']}], 'interventions': [{'name': 'levalbuterol', 'type': 'DRUG', 'description': '0.5 ml. levalbuterol', 'armGroupLabels': ['levalbuterol + ipratroprium in a breath actuated nebulizer', 'levalbuterol + saline in a breath actuated nebulizer']}, {'name': 'saline', 'type': 'DRUG', 'description': '0.5ml saline', 'armGroupLabels': ['levalbuterol + saline in a breath actuated nebulizer']}, {'name': 'levalbuterol MDI', 'type': 'OTHER', 'armGroupLabels': ['levalbuterol MDI + aerochamber max with 2 second pause 2 puffs', 'levalbuterol MDI + aerochamber max without pause 2 puffs', 'levalbuterol MDI 2 puffs']}, {'name': 'breath actuated nebulizer', 'type': 'DEVICE', 'armGroupLabels': ['levalbuterol + ipratroprium in a breath actuated nebulizer', 'levalbuterol + saline in a breath actuated nebulizer']}, {'name': 'aerochamber max', 'type': 'DEVICE', 'armGroupLabels': ['levalbuterol MDI + aerochamber max with 2 second pause 2 puffs', 'levalbuterol MDI + aerochamber max without pause 2 puffs']}, {'name': 'ipratroprium', 'type': 'DRUG', 'armGroupLabels': ['levalbuterol + ipratroprium in a breath actuated nebulizer']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Neil MacIntyre, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}