Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2026-03-01 @ 9:58 AM
Study NCT ID:
NCT02487394
Status:
TERMINATED
Last Update Posted:
2023-04-18
First Post:
2015-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Protein Biomarker Discovery and Validation in Chronic Obstructive Pulmonary Disease (COPD) And Asthma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}, {'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], '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'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'wjcalhou@utmb.edu', 'phone': '409-772-1176', 'title': 'William Calhoun, M.D.', 'organization': 'UTMB'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'It was anticipated to enroll in 4 arms of the study, only 2 arms had successful enrollment.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Asthma, Non-Smokers', 'description': 'Asthma subjects were required to have a phyician diagnosis of asthma, requiring PRN beta2 agonists, with or without an inhaled corticosteroid.\n\nNo smoking asthmatic subjects were included in this arm.', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 0, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'COPD, Smokers', 'description': 'COPD subjects were required to have a physician diagnosis of COPD, and treatment with short- or long-acting muscarinic antagonists, or short- or long-acting beta2 agonists, with or without inhaled corticosteroids. All COPD subjects were current smokers. We did not enroll former smokers in this arm.', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Exhaled Breath Condensate Protein Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'COPD, Smokers', 'description': 'For Phase II, Phase II will again be divided into two arms based on active smoking status as discussed previously.\n\nAsthma, Smokers and Non-Smokers: Comparing protein expressions between the two groups.\n\nCOPD, Smokers and Non-Smokers: We will validate the prdictive value of the proteomic signatures for therapeutic responses.'}, {'id': 'OG001', 'title': 'Asthma, Non-Smokers', 'description': 'In Phase I, One arm will contain subjects who are active smokers and the other arm will contain subjects with no active smoking. Active smoking will be defined as daily use of cigarettes, pipes, cigarillos or cigars at time of entry into the study and through duration of study. No active smoking defined as never smoking or having stopped smoking for 5 years or greater.\n\nAsthma, Smokers and Non-Smokers: Comparing protein expressions between the two groups.\n\nCOPD, Smokers and Non-Smokers: We will validate the prdictive value of the proteomic signatures for therapeutic responses.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'spread': '0', 'comment': 'All concentrations below the level of detection', 'groupId': 'OG000'}, {'value': 'NA', 'spread': '0', 'comment': 'All concentrations below the level of detection', 'groupId': 'OG001'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '1 year through study completion', 'description': 'Protein concentrations were below the limit of detectability and are not scientifically robust.', 'unitOfMeasure': 'ug/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'An observational Study principally for collecting biological samples.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Asthma Subjects-Non-Smokers', 'description': 'Asthma subjects were required to have a phyician diagnosis of asthma, requiring as needed beta2 agonists, with or without an inhaled corticosteroid.\n\nNo smoking asthmatic subjects were included in this arm.'}, {'id': 'FG001', 'title': 'COPD Subjects-Smokers', 'description': 'COPD subjects were required to have a physician diagnosis of COPD, and treatment with short- or long-acting muscarinic antagonists, or short- or long-acting beta2 agonists, with or without inhaled corticosteroids. All COPD subjects were current smokers. We did not enroll former smokers in this arm.'}], 'periods': [{'title': 'Phase 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'comment': 'One subject was withdrawn', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Phase 2', 'milestones': [{'type': 'STARTED', 'comment': 'Only 4 subjects who completed phase I enrolled in phase II of asthmatics. None of the COPD subjects who completed phase 1 enrolled in phase II.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Anticipated to enroll both smoking and non-smoking asthma subjects. Anticipated to enroll both smoking and non-smoking COPD subjects. NO smoking asthmatic subjects enrolled. NO non-smoking COPD subjects enrolled. There are only two groups.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Asthma, Non-Smokers', 'description': 'No active smoking defined as never smoking or having stopped smoking for 5 years or greater.'}, {'id': 'BG001', 'title': 'COPD, Smokers', 'description': 'Active smoking will be defined as daily use of cigarettes, pipes, cigarillos or cigars at time of entry into the study and through duration of study.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'The overall participants was a total of 9.'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}, 'targetDuration': '1 Week', 'patientRegistry': True}, 'statusModule': {'whyStopped': 'NIH Funded Grant Expired', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-14', 'studyFirstSubmitDate': '2015-02-12', 'resultsFirstSubmitDate': '2017-04-12', 'studyFirstSubmitQcDate': '2015-06-26', 'lastUpdatePostDateStruct': {'date': '2023-04-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-04-14', 'studyFirstPostDateStruct': {'date': '2015-07-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Exhaled Breath Condensate Protein Concentration', 'timeFrame': '1 year through study completion', 'description': 'Protein concentrations were below the limit of detectability and are not scientifically robust.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Asthma', 'COPD']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to better understand proteomics of asthma and COPD, and response to therapy. There are two Phases to this study broken into two arms. In Phase I, we propose is to use discovery proteomics and techniques to identify protein expression signatures. Subjects who complete Phase I are eligible, but not required, to enroll in Phase II. In Phase II, we propose to establish and validate the predictive value of protein signatures for treatment responses using inhaled corticosteroids.', 'detailedDescription': 'There are two Phases to this study broken into two arms. In Phase I, our propose to use discovery proteomics and high throughput techniques to identify protein expression signatures. The total planned size of Phase I is 100 patients. Patients will be divided into two arms based on disease status (COPD or asthma). Active smoking will be defined as daily use of cigarettes, pipes, cigarillos or cigars at time of entry into the study and through duration of study. No active smoking defined as never smoking or having stopped smoking for 5 years or greater.\n\nIn the Phase II, we aim to establish and validate the predictive value of proteomic signatures for therapeutic responses using inhaled corticosteroids. For Phase II, subjects who completed Phase I are eligible, but not required to participate in Phase II.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients will be divided into two identical arms based on smoking status. One arm will contain subjects who are active smokers and the other arm will contain subjects with no active smoking.\n\nEach arm will contain 50 subjects, 26 with COPD (Stage II and III with 13 subjects in each) along with 24 asthmatics (Mild to Moderate disease with 12 subjects in each).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Criteria for Asthma\n\nINCLUSION\n\n* History consistent with asthma: episodic wheezing, shortness of breath, or cough\n* Airway lability recognized by at least 12% improvement in Forced Expiratory Volume (FEV1) after 2 puffs of beta2 agonist Age \\>18yrs\n* FEV1 \\>40% predicted\n* Never smoker, current smoker, or quit smoking ≥5 years ago Criteria for COPD\n\nINCLUSION\n\n* History consistent with COPD: dyspnea with exertion, productive cough, progressive course\n* Smoking history of at least 20 pack years\n* Current smoker or quit smoking ≥5 years ago\n* Age \\>18yrs\n* FEV1: Forced Vital Capacity (FVC) ratio \\< 0.70 following 2 puffs of albuterol\n* FEV1 greater than 50% predicted\n\nExclusion Criteria:\n\n* Exclusion for Asthma EXCLUSION\n\n * Other respiratory illness other than asthma\n * Chronic infectious process\n * Significant other medical illness\n * Inability to consent\n * Pregnancy Exclusion for COPD EXCLUSION\n * Other respiratory illness other than COPD\n * Chronic infectious process\n * Significant other medical illness\n * Inability to consent\n * Pregnancy'}, 'identificationModule': {'nctId': 'NCT02487394', 'acronym': 'Proteomics', 'briefTitle': 'Protein Biomarker Discovery and Validation in Chronic Obstructive Pulmonary Disease (COPD) And Asthma', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Medical Branch, Galveston'}, 'officialTitle': 'Protein Biomarker Discovery and Validation in COPD And Asthma', 'orgStudyIdInfo': {'id': '13-0462'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'COPD Smoker Subjects', 'description': 'Smokers Active smoking will be defined as daily use of cigarettes, pipes, cigarillos or cigars at time of entry into the study and through duration of study.', 'interventionNames': ['Procedure: Exhaled Breath Condensate (EBC)']}, {'label': 'Asthma Non-Smoker Subjects', 'description': 'Non-Smokers Subjects with no active smoking. No active smoking defined as never smoking or having stopped smoking for 5 years or greater.', 'interventionNames': ['Procedure: Exhaled Breath Condensate (EBC)']}], 'interventions': [{'name': 'Exhaled Breath Condensate (EBC)', 'type': 'PROCEDURE', 'description': 'Collection of EBC condensate', 'armGroupLabels': ['Asthma Non-Smoker Subjects', 'COPD Smoker Subjects']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77555', 'city': 'Galveston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Medical Branch', 'geoPoint': {'lat': 29.30135, 'lon': -94.7977}}], 'overallOfficials': [{'name': 'William Calhoun, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UTMB'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Medical Branch, Galveston', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}