Evaluation of Biological and Functional Changes in Healthy Smokers After Switching to THS 2.2 for 26 Weeks

Summary

The aim of the study is to demonstrate clinical, biological and functional health changes in smokers switching to the candidate modified risk tobacco product: Tobacco Heating System 2.2 (THS 2.2) as compared to smokers continuing smoking their conventional cigarettes (CC) over a 26-week period.

To characterize the study as successful, at least 5 clinical risk endpoints should move in the direction of smoking cessation and these results would be statistically significant. The main analysis will be defined a priori (using the Hailperin-Ruger approach) and will be made between THS 2.2 use and CC use as "per actual product used" and product use categories.

Conditions

• Smoking

Interventions

OTHER

THS 2.2

Ad libitum use of THS 2.2 in an ambulatory setting for 26 weeks

OTHER

CC

Ad libitum use of CC in an ambulatory setting for 26 weeks

Sponsors & Collaborators

• Philip Morris Products S.A.

  lead INDUSTRY

Principal Investigators

• Christelle Haziza, PhD · Philip Morris Products S.A.

• Danielle Armas, MD · Celerion Arizona

• Leonard Dunn, MD · Clinical Research West Florida

• Hugh Coleman, MD · Covance

• George Stoica, MD · Compass Research

• Mark Adams, MD · Central Kentucky Research Associate

• Peter Davidson, MD · Celerion Lincoln

• John Rubino, MD · PMG Research of Raleigh

• George Raad, MD · PMG Research of Charlotte

• Kevin Cannon, MD · PMG Research of Wilmington

• Derek Schroder, MD · PMG Research of Cary

• Stephanie Powell, MD · PMG Research of Bristol

• William Smith, MD · NOCCR

• Darrell Herrington, MD · Benchmark

• Laurence Chu, MD · Benchmark

• William Seger, MD · Benchmark

• Lon Lynn, MD · Clinical Research West Florida

• David Subich, MD · Compass Research

• Isabel Kuhare-Arcure, MD · Midwest Clinical Research

• Keith Scott, MD · National Clinical Research

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

30 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2015-03-12

Primary Completion

2016-09-13

Completion

2017-08-01

Countries

• United States

Study Locations