Ignite Creation Date:
2025-12-25 @ 12:28 AM
Ignite Modification Date:
2026-01-01 @ 9:51 AM
Study NCT ID:
NCT00670267
Status:
COMPLETED
Last Update Posted:
2016-05-11
First Post:
2008-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Oral Nadolol for the Treatment of Adults With Mild 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': 'D009248', 'term': 'Nadolol'}], 'ancestors': [{'id': 'D050198', 'term': 'Phenoxypropanolamines'}, {'id': 'D011412', 'term': 'Propanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D020005', 'term': 'Propanols'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'hanania@bcm.edu', 'title': 'N.A. Hanania, M.D.', 'organization': 'Baylor College of Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Open Label', 'description': 'nadolol: Nadolol, oral taken daily, doses will be escalated every two weeks over 13 weeks following a 2 week run-in.', 'otherNumAtRisk': 10, 'otherNumAffected': 1, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Reduced pulmonary function', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Daily Dose at Study Termination Across Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Open Label Treatment With Oral Nadolol', 'description': 'Dose escalation through 1.25mgs, 2.5mgs, 5.0mgs, 10mgs, 20mgs, and 40mgs of nadolol at 2 week intervals as tolerated.\n\nnadolol: Nadolol, oral taken daily, doses will be escalated every two weeks over 13 weeks following a 2 week run-in.'}], 'classes': [{'categories': [{'measurements': [{'value': '29.6', 'spread': '16.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to end of study (105 days)', 'description': 'The outcome measure describes the mean daily dose achieved by the subjects at study termination. This data includes one subject who terminated early, having reached 2.5mgs and subsequently reducing to 1.25mgs prior to dropping out.', 'unitOfMeasure': 'mg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Daily Dose at Study Termination Across Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Open Label Treatment With Oral Nadolol', 'description': 'Dose escalation through 1.25mgs, 2.5mgs, 5.0mgs, 10mgs, 20mgs, and 40mgs of nadolol at 2 week intervals as tolerated.'}], 'classes': [{'title': '1.25mgs', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': '2.5mgs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '5.0mgs', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': '10.0mgs', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': '20mgs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '40mgs', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to end of study (105 days)', 'description': 'The outcome measure describes the final daily dose achieved by the subjects in this study. The subjects described below who finished on less than the highest dose (i.e., 1.25, 5, and 10mgs) had all been down-titrated one dose (i.e., from 2.5, 10, and 20mgs) prior to completing the study on the dose reported.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Airway Hyper-reactivity Compared to Baseline (Change in PC20 Doubling Dose by Methacholine Challenge)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Open Label Treatment With Oral Nadolol'}], 'classes': [{'categories': [{'measurements': [{'value': '1.8', 'spread': '1.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to end of study (105 days)', 'description': 'Bronchoprovocation assessment was done by doubling doses of methacholine in accordance with the methodology recommended by the American Thoracic Society in the official policy statement adopted by the ATS Board of Directors, July 1999 (Guidelines for Methacholine and Exercise Challenge Testing-1999).', 'unitOfMeasure': 'mg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis excludes one early termination subject'}, {'type': 'SECONDARY', 'title': 'Percent Change in FEV1% Predicted From Baseline to End of Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Open Label Treatment With Oral Nadolol'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.9', 'spread': '9.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to end of study (105 days)', 'unitOfMeasure': 'percent change in FEV1% predicted', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Asthma Control Questionnaire (ACQ) Score Compared to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Open Label Treatment With Oral Nadolol'}], 'classes': [{'categories': [{'measurements': [{'value': '0.3', 'spread': '0.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to end of study (105 days)', 'description': 'In the E.F. Juniper Asthma Control Questionnaire, a lower number reflects better control of asthma symptoms. A positive change in ACQ score reflects a reduction in control compared to baseline; conversely, a negative change in ACQ score reflects an increase in control compared to baseline. The ACQ has 7 questions (the top scoring 5 symptoms, FEV1% pred. and daily rescue bronchodilator use). Patients are asked to recall how their asthma has been during the previous week and to respond to the symptom and bronchodilator use questions on a 7-point scale (0=no impairment, 6= maximum impairment). Clinic staff score the FEV1% predicted on a 7-point scale. The questions are equally weighted and the ACQ score is the mean of the 7 questions and therefore between 0 (totally controlled) and 6 (severely uncontrolled).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Open Label Treatment With Oral Nadolol', 'description': 'Dose escalation through 1.25mgs, 2.5mgs, 5.0mgs, 10mgs, 20mgs, and 40mgs of nadolol at 2 week intervals as tolerated.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Open Label', 'description': 'nadolol: Nadolol, oral taken daily, doses will be escalated every two weeks over 13 weeks following a 2 week run-in.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '32.6', 'groupId': 'BG000', 'lowerLimit': '18', 'upperLimit': '49'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '2', '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-06', 'studyFirstSubmitDate': '2008-04-29', 'resultsFirstSubmitDate': '2015-06-16', 'studyFirstSubmitQcDate': '2008-04-29', 'lastUpdatePostDateStruct': {'date': '2016-05-11', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-04-06', 'studyFirstPostDateStruct': {'date': '2008-05-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-05-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Daily Dose at Study Termination Across Participants', 'timeFrame': 'Baseline to end of study (105 days)', 'description': 'The outcome measure describes the mean daily dose achieved by the subjects at study termination. This data includes one subject who terminated early, having reached 2.5mgs and subsequently reducing to 1.25mgs prior to dropping out.'}, {'measure': 'Daily Dose at Study Termination Across Participants', 'timeFrame': 'Baseline to end of study (105 days)', 'description': 'The outcome measure describes the final daily dose achieved by the subjects in this study. The subjects described below who finished on less than the highest dose (i.e., 1.25, 5, and 10mgs) had all been down-titrated one dose (i.e., from 2.5, 10, and 20mgs) prior to completing the study on the dose reported.'}], 'secondaryOutcomes': [{'measure': 'Change in Airway Hyper-reactivity Compared to Baseline (Change in PC20 Doubling Dose by Methacholine Challenge)', 'timeFrame': 'Baseline to end of study (105 days)', 'description': 'Bronchoprovocation assessment was done by doubling doses of methacholine in accordance with the methodology recommended by the American Thoracic Society in the official policy statement adopted by the ATS Board of Directors, July 1999 (Guidelines for Methacholine and Exercise Challenge Testing-1999).'}, {'measure': 'Percent Change in FEV1% Predicted From Baseline to End of Study', 'timeFrame': 'Baseline to end of study (105 days)'}, {'measure': 'Change in Asthma Control Questionnaire (ACQ) Score Compared to Baseline', 'timeFrame': 'Baseline to end of study (105 days)', 'description': 'In the E.F. Juniper Asthma Control Questionnaire, a lower number reflects better control of asthma symptoms. A positive change in ACQ score reflects a reduction in control compared to baseline; conversely, a negative change in ACQ score reflects an increase in control compared to baseline. The ACQ has 7 questions (the top scoring 5 symptoms, FEV1% pred. and daily rescue bronchodilator use). Patients are asked to recall how their asthma has been during the previous week and to respond to the symptom and bronchodilator use questions on a 7-point scale (0=no impairment, 6= maximum impairment). Clinic staff score the FEV1% predicted on a 7-point scale. The questions are equally weighted and the ACQ score is the mean of the 7 questions and therefore between 0 (totally controlled) and 6 (severely uncontrolled).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Asthma', 'hyperresponsiveness'], 'conditions': ['Asthma']}, 'referencesModule': {'references': [{'pmid': '17703976', 'type': 'BACKGROUND', 'citation': "Hanania NA, Singh S, El-Wali R, Flashner M, Franklin AE, Garner WJ, Dickey BF, Parra S, Ruoss S, Shardonofsky F, O'Connor BJ, Page C, Bond RA. The safety and effects of the beta-blocker, nadolol, in mild asthma: an open-label pilot study. Pulm Pharmacol Ther. 2008;21(1):134-41. doi: 10.1016/j.pupt.2007.07.002. Epub 2007 Jul 17."}, {'pmid': '19171883', 'type': 'BACKGROUND', 'citation': 'Nguyen LP, Lin R, Parra S, Omoluabi O, Hanania NA, Tuvim MJ, Knoll BJ, Dickey BF, Bond RA. Beta2-adrenoceptor signaling is required for the development of an asthma phenotype in a murine model. Proc Natl Acad Sci U S A. 2009 Feb 17;106(7):2435-40. doi: 10.1073/pnas.0810902106. Epub 2009 Jan 26.'}], 'seeAlsoLinks': [{'url': 'http://erj.ersjournals.com/content/36/4/963.long', 'label': 'ERS Publication: Response to salbutamol in patients with mild asthma treated with nadolol'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to confirm previous observations in asthmatics that chronic nadolol treatment reduces asthmatic airway hyper-responsiveness.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pre-bronchodilator FEV1 80% or greater than the predicted value.\n* PC20 FEV1 ≤4 mg/ml on methacholine challenge test.\n* Blood Pressure ≥ 100/65mm Hg.\n* Pulse rate ≥ 60 beats/min.\n* No significant health issues.\n* Non-smoker or X-smoker \\< 10 pack/year.\n\nExclusion Criteria:\n\n* History of upper/lower respiratory tract infection or asthma exacerbation within 6 weeks of first baseline visit.\n* Currently diagnosed with chronic obstructive pulmonary disease (COPD).\n* Used any oral or inhaled corticosteroids within 4 weeks of the first baseline visit.'}, 'identificationModule': {'nctId': 'NCT00670267', 'briefTitle': 'Oral Nadolol for the Treatment of Adults With Mild Asthma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Invion, Inc.'}, 'officialTitle': 'An Open-Label, Dose-Escalating, Study to Evaluate the Safety, Efficacy and Tolerability of Oral Nadolol for the Treatment of Adults With Mild Asthma', 'orgStudyIdInfo': {'id': 'SAND1002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Open Label treatment with oral Nadolol', 'description': 'Dose escalation through 1.25mgs, 2.5mgs, 5.0mgs, 10mgs, 20mgs, and 40mgs of nadolol at 2 week intervals as tolerated.', 'interventionNames': ['Drug: nadolol']}], 'interventions': [{'name': 'nadolol', 'type': 'DRUG', 'otherNames': ['Corgard'], 'description': 'Nadolol, oral taken daily, doses will be escalated every two weeks over 13 weeks following a 2 week run-in.', 'armGroupLabels': ['Open Label treatment with oral Nadolol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor College of Medicine', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Nicola A Hanania, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Houston'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Invion, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'University of Houston', 'class': 'OTHER'}, {'name': 'Sandler Program for Asthma Research', 'class': 'OTHER'}, {'name': 'Baylor College of Medicine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}