A 26-week Extension of the ZRHR-ERS-09-US Study Evaluating Biological and Functional Changes in Healthy Smokers After Switching to THS 2.2

Summary

The objective of the ZRHR-ERS-09-EXT-US study is to further assess the effect of the Tobacco Heating System 2.2 (THS 2.2), a candidate Modified Risk Tobacco Product, compared to conventional cigarettes (CC) on the components of the "smokers' health profile" for a prolonged period of 26 weeks, providing additional information to the results of the original study ZRHR-ERS-09-US of 26-week exposure (NCT02396381). In total, the ZRHR-ERS-09-EXT-US study will extend the exposure period to 52 weeks.

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. The subject's own preferred brands of CC (no brand restriction) continue to be used as the reference product.

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

• David Subich, MD · Compass Research

• Lon Lynn, MD · Clinical Research West Florida

• 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

2015-09-30

Primary Completion

2017-03-13

Completion

2017-12-20

Countries

• United States

Study Locations