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Electronic Cigarette-derived Oxidants and Cardiopulmonary Effects

StatusActive, Not Recruiting
PhaseEarly Phase 1
Started
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Record History

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  1. Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Jun 30, 2025 to Jun 30, 2026
    • Site details revised
    v14
  2. Primary and study completion dates: Nov 2025 to Jun 30, 2025v13
  3. Phase: Not applicable to Early Phase 1
    • Primary and study completion dates: Nov 2024 to Nov 2025
    • Interventions: NJOY e-cigarette (Other) to NJOY e-cigarette (Drug)
    v12
  4. Primary and study completion dates: Feb 2024 to Nov 2024
    • Secondary endpoints: details revised at 4 of 4 entries
    • Site contact updated
    v11
  5. Eligibility criteria shortened, about 8 wordsv10
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  1. Start date changed from estimate of Nov 2022 to Nov 22, 2022v9
  2. Start date: Oct 2022 to Nov 2022v8
  3. Start date: Sep 2022 to Oct 2022v7
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Aug 2022 to Sep 2022
    • Interventions: JUUL e-cigarette (Other) to NJOY e-cigarette (Other)
    • Site details revised
    v6
  5. Start date: Jun 2022 to Aug 2022v5
  6. Start date: Apr 2022 to Jun 2022v4
  7. Collaborators expanded, about 7 wordsv3
  8. Start date: Feb 2022 to Apr 2022v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05239793
Lead Sponsor Milton S. Hershey Medical Center
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Conditions
(from sponsor)		 Chronic Obstructive Pulmonary Disease
Related terms Pulmonary Disease, Chronic Obstructive
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov