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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

NCT ID: NCT02649556

Last Updated: 2020-12-04

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

672 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2017-12-20

Brief Summary

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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.

Detailed Description

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The ZRHR-ERS-09-EXT-US study is a 26-week extension of the original study ZRHR-ERS-09-US.

The subjects in the Full Analysis Set - As Exposed (FAS-EX) included subjects for combined analyses from the original six month study (ZRHR-ERS-09-US ) who did not enter the extension study (ZRHR-ERS-09-EXT-US).

This study was conducted as a separate investigation, as a follow-up of the randomized exposure period of the original study, extending the exposure from Week 26 (Visit 10 \[V10\]) to Week 52 (Visit 16 \[V16\]), and using the same sites.

Subjects continued to use the product they were randomized to in the original study ZRHR-ERS-09-US (THS 2.2 arm or CC arm).

Conditions

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Smoking

Keywords

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Modified risk tobacco product Conventional cigarette Exposure response Smoking Tobacco Heating System

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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THS 2.2

Ad libitum use of THS 2.2

Group Type EXPERIMENTAL

THS 2.2

Intervention Type OTHER

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

CC

Ad libitum use of CC

Group Type ACTIVE_COMPARATOR

CC

Intervention Type OTHER

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.

Interventions

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THS 2.2

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

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Subject completed V10 of the original study (ZRHR-ERS-09-US).
* The subject is willing to comply to study procedures and to continue to use the product he/she was allocated to during the original study (THS 2.2 or CC) for an additional 26 weeks at V10.
* Subject has given written informed consent to enter the 26-week extension study at V10.

Exclusion Criteria

* Clinically relevant medical conditions that in the opinion of the investigators would jeopardize the safety of the participant.
* As per judgment of the PI(s) or designee(s), the subject cannot participate in the study for any reason (e.g. medical, psychiatric and/or social reason).
* Subject has made an attempt to quit using tobacco-containing products (e.g. CC and THS 2.2) during the original study.
* Female subject is pregnant or breast feeding.
* Female subject who does not agree to use an acceptable method of effective contraception.
Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Philip Morris Products S.A.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christelle Haziza, PhD

Role: STUDY_CHAIR

Philip Morris Products S.A.

Danielle Armas, MD

Role: PRINCIPAL_INVESTIGATOR

Celerion Arizona

Leonard Dunn, MD

Role: PRINCIPAL_INVESTIGATOR

Clinical Research West Florida

Hugh Coleman, MD

Role: PRINCIPAL_INVESTIGATOR

Covance

George Stoica, MD

Role: PRINCIPAL_INVESTIGATOR

Compass Research

Mark Adams, MD

Role: PRINCIPAL_INVESTIGATOR

Central Kentucky Research Associate

Peter Davidson, MD

Role: PRINCIPAL_INVESTIGATOR

Celerion Lincoln

John Rubino, MD

Role: PRINCIPAL_INVESTIGATOR

PMG Research of Raleigh

George Raad, MD

Role: PRINCIPAL_INVESTIGATOR

PMG Research of Charlotte

Kevin Cannon, MD

Role: PRINCIPAL_INVESTIGATOR

PMG Research of Wilmington

Derek Schroder, MD

Role: PRINCIPAL_INVESTIGATOR

PMG Research of Cary

Stephanie Powell, MD

Role: PRINCIPAL_INVESTIGATOR

PMG Research of Bristol

William Smith, MD

Role: PRINCIPAL_INVESTIGATOR

NOCCR

Darrell Herrington, MD

Role: PRINCIPAL_INVESTIGATOR

Benchmark

Laurence Chu, MD

Role: PRINCIPAL_INVESTIGATOR

Benchmark

William Seger, MD

Role: PRINCIPAL_INVESTIGATOR

Benchmark

David Subich, MD

Role: PRINCIPAL_INVESTIGATOR

Compass Research

Lon Lynn, MD

Role: PRINCIPAL_INVESTIGATOR

Clinical Research West Florida

Isabel Kuhare-Arcure, MD

Role: PRINCIPAL_INVESTIGATOR

Midwest Clinical Research

Keith Scott, MD

Role: PRINCIPAL_INVESTIGATOR

National Clinical Research

Locations

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Celerion Arizona

Tempe, Arizona, United States

Site Status

Clinical Research West Florida

Clearwater, Florida, United States

Site Status

Covance, Inc

Daytona Beach, Florida, United States

Site Status

Compass Research

Orlando, Florida, United States

Site Status

Clinical Research West Florida

Tampa, Florida, United States

Site Status

Compass Research

The Villages, Florida, United States

Site Status

Central Kentucky Research Associate

Lexington, Kentucky, United States

Site Status

Celerion Lincoln

Lincoln, Nebraska, United States

Site Status

PMG Research of Cary

Cary, North Carolina, United States

Site Status

PMG Research of Charlotte

Charlotte, North Carolina, United States

Site Status

PMG Research of Raleigh

Raleigh, North Carolina, United States

Site Status

PMG Research of Wilmington

Wilmington, North Carolina, United States

Site Status

Midwest Clinical Research

Dayton, Ohio, United States

Site Status

PMG Research of Bristol

Bristol, Tennessee, United States

Site Status

NOCCR

Knoxville, Tennessee, United States

Site Status

Benchmark

Austin, Texas, United States

Site Status

Benchmark

Fort Worth, Texas, United States

Site Status

Benchmark

San Angelo, Texas, United States

Site Status

National Clinical Research

Richmond, Virginia, United States

Site Status

Countries

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United States

References

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Ansari SM, Hession PS, David M, Blanc N, de La Bourdonnaye G, Pouly S, Haziza C. Impact of switching from cigarette smoking to tobacco heating system use on biomarkers of potential harm in a randomized trial. Biomarkers. 2024 Jul;29(5):298-314. doi: 10.1080/1354750X.2024.2358318. Epub 2024 Jun 7.

Reference Type DERIVED
PMID: 38804903 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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ZRHR-ERS-09-EXT-US

Identifier Type: OTHER

Identifier Source: secondary_id

ZRHR-ERS-09-EXT-US

Identifier Type: -

Identifier Source: org_study_id