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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HL152436 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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%).
This 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NJOY e-cigarette | Other | NJOY e-cigarette containing 5% nicotine strength pods |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NJOY e-cigarette | Drug | NJOY e-cigarette with Virginia Tobacco flavored 5% nicotine pods |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cigarettes per day | Self reported cigarettes per day | 3 months |
| Number of exacerbations | Number of COPD exacerbations | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Lung function tests (spirometry) | FEV1 | 3 months |
| COPD Assessment Test (CAT) scores | 8-item scale with range of scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rebecca Bascom, MD | Penn State Health Hershey Medical Center | Principal Investigator |
| Raghu Sinha, PhD | Penn State Health Hershey Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn State Health Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
We propose to make de-identified data, codebooks, documentation, and research protocols available to interested researchers after completion of the study.
Data will be available within 3 years of the culmination of data collection activities.
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.
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| 3 months |
| 6-min walk distance (6MWD) | This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes. | 3 months |
| Tobacco exposure | Measure by cotinine (ng/ml) | 3 months |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |