Clinical Studies

      Comparison of Abdominal Aortic Aneurysm Growth in Adult Smoking Patients Who Either Switch to IQOS, Continue Smoking, or Quit Smoking

      First posted
      Feb 12, 2019
      Identifier
      NCT03837704
      Publication Site URL
      Topic
      Official Title

      A Controlled, Open-label, 3-arm Parallel Group, Multi-center Study to Evaluate the Abdominal Aortic Aneurysm (AAA) Growth Rate in Adult Smoking Patients Randomized to Either Cigarette Smoking or IQOS Use and to Compare With the AAA Growth Rate in Patients Who Had Stopped Smoking

      Brief Summary

      The abdominal aortic aneurysm (AAA) study was an exploratory effort designed to assess the annual growth rate of abdominal aortic aneurysms in (1) smokers who continue to smoke cigarettes, (2) smokers who stop smoking altogether, and (3) smokers who switched to the Tobacco Heating System (THS), commercially known as IQOS. Due to recruitment and enrollment challenges, recruitment stopped before reaching the target sample size (48 of the planned 114 patients were enrolled into the study). Recognizing the smaller-than-planned cohort would not yield sufficient data for substantive (meaningful/credible/interpretative/reliable) analysis, the follow-up period was also shortened. While these adjustments limited the study's ability to provide credible insights, it provided valuable learnings on conducting postmarket studies on tobacco products and highlighted some of the evolving nature of research and the commitment to resource optimization in scientific research. While the results are limited due to the adjustments in the study design, the results are shared openly and transparently in the video below and have been submitted for publication on clinicaltrial.gov.

      Abstract

      Recruitment: Completed

      Study Results: See video

      Enrollment: Planned 114, actual 48

      Study Type: Interventional

      Other IDs: P1-AAA-02-JP

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