Ignite Creation Date:
2025-12-25 @ 1:17 AM
Ignite Modification Date:
2025-12-28 @ 11:24 PM
Study NCT ID:
NCT05239793
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-27
First Post:
2022-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Electronic Cigarette-derived Oxidants and Cardiopulmonary Effects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-11-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-23', 'studyFirstSubmitDate': '2022-02-04', 'studyFirstSubmitQcDate': '2022-02-04', 'lastUpdatePostDateStruct': {'date': '2025-10-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cigarettes per day', 'timeFrame': '3 months', 'description': 'Self reported cigarettes per day'}, {'measure': 'Number of exacerbations', 'timeFrame': '3 months', 'description': 'Number of COPD exacerbations'}], 'secondaryOutcomes': [{'measure': 'Lung function tests (spirometry)', 'timeFrame': '3 months', 'description': 'FEV1'}, {'measure': 'COPD Assessment Test (CAT) scores', 'timeFrame': '3 months', 'description': "8-item scale with range of scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life."}, {'measure': '6-min walk distance (6MWD)', 'timeFrame': '3 months', 'description': 'This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes.'}, {'measure': 'Tobacco exposure', 'timeFrame': '3 months', 'description': 'Measure by cotinine (ng/ml)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'descriptionModule': {'briefSummary': 'This is a pilot study on the impact of switching from cigarettes to Electronic Cigarettes (EC) on disease-related clinical symptoms and biomarkers of harm in smokers with preexisting Chronic Obstructive Pulmonary Disease (COPD). The researchers hypothesize that the smokers who switch to EC completely or significantly will experience reduced COPD symptoms, risks of exacerbations, and decreased levels of oxidative stress and inflammation.', 'detailedDescription': 'Smokers with COPD have a higher pack-year history and nicotine dependence compared to regular smokers as exemplified by the relatively large proportion of patients diagnosed with COPD that continue to smoke (95%).\n\nThis is a translational project which addresses the changing profile of tobacco product use in the United States (US) and the need for data regarding toxicity pathways for new nicotine products such as EC. In particular it focuses on critical scientific and clinically relevant gaps relating to oxidants in EC and their potential long-term cardiopulmonary effects. The study will obtain new information regarding the potential cardiopulmonary toxicity resulting from exposure to EC-derived oxidants that may lead to long-term disease development.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Mild to moderate COPD\n* Smokes a popular brand of cigarette\n* Willing to use an e-cigarette to reduce cigarette smoking down to 75% of their daily baseline cigarette use\n* Ability to read, write and understand English\n* Ability to provide informed consent and attend study visits\n\nExclusion Criteria:\n\n* History of active, chronic drug abuse or alcohol abuse problems\n* Actively changing smoking behavior\n* Unwilling or unable to provide blood samples\n* Pregnant, planning to become pregnant, or nursing\n* Use of tobacco products other than cigarettes in the past 30 days\n* Recent history (\\< 6 months) of myocardial infarction (MI)\n* Any unstable or life threatening cardiac arrhythmia or cardiac arrhythmia requiring intervention or drug therapy within the past year. Antiarrhythmic drugs include amiodarone, flecainide, IV ibutilide, IV lidocaine, procainamide, propafenone, quinidine, tocainide\n* Hospitalization for heart failure (NY Heart Association III or IV) within the past year\n* Uncontrolled hypertension\n* Known allergy to vegetable glycerin and propylene glycol\n* History of seizures or medications to prevent seizures'}, 'identificationModule': {'nctId': 'NCT05239793', 'briefTitle': 'Electronic Cigarette-derived Oxidants and Cardiopulmonary Effects', 'organization': {'class': 'OTHER', 'fullName': 'Milton S. Hershey Medical Center'}, 'officialTitle': 'Translational Studies on Electronic Cigarette-derived Oxidants and Their Long-term Cardiopulmonary Effects', 'orgStudyIdInfo': {'id': 'STUDY00015514'}, 'secondaryIdInfos': [{'id': '1R01HL152436', 'link': 'https://reporter.nih.gov/quickSearch/1R01HL152436', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'NJOY e-cigarette', 'description': 'NJOY e-cigarette containing 5% nicotine strength pods', 'interventionNames': ['Drug: NJOY e-cigarette']}], 'interventions': [{'name': 'NJOY e-cigarette', 'type': 'DRUG', 'description': 'NJOY e-cigarette with Virginia Tobacco flavored 5% nicotine pods', 'armGroupLabels': ['NJOY e-cigarette']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Penn State Health Milton S. Hershey Medical Center', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}], 'overallOfficials': [{'name': 'Rebecca Bascom, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Penn State Health Hershey Medical Center'}, {'name': 'Raghu Sinha, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Penn State Health Hershey Medical Center'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Data will be available within 3 years of the culmination of data collection activities.', 'ipdSharing': 'YES', 'description': 'We propose to make de-identified data, codebooks, documentation, and research protocols available to interested researchers after completion of the study.', 'accessCriteria': 'Any investigator interested in collaboration or in using the data collected in this study for their own work will be invited to submit a 1-page abstract of their proposed research, including purpose, analytical plan, and dissemination plans. The study leadership team will review these proposals and decide on each based on the individual merits. Review criteria and prioritization of projects include: potential of the proposed work to advance public health, qualifications of the applicant, the potential for publication, the potential for future funding, and enhancing the scientific, geographic, and demographic diversity of the research portfolio.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Milton S. Hershey Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Department of Medicine', 'investigatorFullName': 'Rebecca Bascom', 'investigatorAffiliation': 'Penn State Health Milton S Hershey Medical Center'}}}}