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

NCT ID: NCT02396381

Last Updated: 2023-01-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1039 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-12
• Study Completion Date: 2017-08-01

Brief 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.

Detailed Description

The clinical, biological and functional endpoints to be measured in this study ("smoker's health profile") may characterize the modification of risk of smoking-related diseases.

Clinical risk endpoint to be assessed are selected based on a) their association to smoking-related diseases b) their association to smoking status, c) their reversibility upon smoking cessation, and d) their suitability to be measured with valid and robust methods in clinical studies.

The biological markers, functional markers and biomarkers of exposure (BoExp) with the strongest scientific evidence will constitute the 'smoker's health profile' and will be measured as the primary objective of the study.

Additional endpoints involved in the mechanistic of smoking-related diseases will be studied to provide additional scientific evidence to strengthen the primary objective.

The study will provide a perspective of product usage in a "real world setting" where smoking CC in addition to THS 2.2 may be expected.

Conditions

Smoking

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Current healthy smoker as judged by the Principal Investigator(s) or designee(s)
• Minimum age: 30 years old
• Have smoked for the last 10 years
• Have smoked more than 10 non menthol CC/day on average (no brand restriction) over the past year

Exclusion Criteria

• Clinically relevant medical conditions that in the opinion of the investigators would jeopardize the safety of the participant.
• Subject who has (FEV1/FVC) < 0.7 and FEV1 < 80% predicted value at post-bronchodilator spirometry
• Subject with asthma condition (post-bronchodilator FEV1/FVC < 0.75 and reversibility in FEV1 ≥ 12% and > 200 mL from pre- to post-bronchodilator values)
• Subject who took or is taking concomitant medication which may have an impact on the "smoker's heath profile"
• 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

Philip Morris Products S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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

Lon Lynn, MD

Role: PRINCIPAL_INVESTIGATOR

Clinical Research West Florida

David Subich, MD

Role: PRINCIPAL_INVESTIGATOR

Compass Research

Isabel Kuhare-Arcure, MD

Role: PRINCIPAL_INVESTIGATOR

Midwest Clinical Research

Keith Scott, MD

Role: PRINCIPAL_INVESTIGATOR

National Clinical Research

Locations

Celerion Arizona

Tempe, Arizona, United States

Clinical Research West Florida

Clearwater, Florida, United States

Covance, Inc

Daytona Beach, Florida, United States

Compass Research

Orlando, Florida, United States

Clinical Research West Florida

Tampa, Florida, United States

Compass Research

The Villages, Florida, United States

Central Kentucky Research Associate

Lexington, Kentucky, United States

Celerion Lincoln

Lincoln, Nebraska, United States

PMG Research of Cary

Cary, North Carolina, United States

PMG Research of Charlotte

Charlotte, North Carolina, United States

PMG Research of Raleigh

Raleigh, North Carolina, United States

PMG Research of Wilmington

Wilmington, North Carolina, United States

Midwest Clinical Research Center

Dayton, Ohio, United States

PMG Research of Bristol

Bristol, Tennessee, United States

NOCCR

Knoxville, Tennessee, United States

Benchmark

Austin, Texas, United States

Benchmark

Fort Worth, Texas, United States

Benchmark

San Angelo, Texas, United States

National Clinical Research

Richmond, Virginia, United States

Countries

United States

References

Ludicke F, Ansari SM, Lama N, Blanc N, Bosilkovska M, Donelli A, Picavet P, Baker G, Haziza C, Peitsch M, Weitkunat R. Effects of Switching to a Heat-Not-Burn Tobacco Product on Biologically Relevant Biomarkers to Assess a Candidate Modified Risk Tobacco Product: A Randomized Trial. Cancer Epidemiol Biomarkers Prev. 2019 Nov;28(11):1934-1943. doi: 10.1158/1055-9965.EPI-18-0915. Epub 2019 Jul 3.

Reference Type: RESULT

PMID: 31270101 (View on PubMed)

Ansari SM, Lama N, Blanc N, Bosilkovska M, Donelli A, Picavet P, Baker G, Haziza C, Ludicke F. Evaluation of Biological and Functional Changes in Healthy Smokers Switching to the Tobacco Heating System 2.2 Versus Continued Tobacco Smoking: Protocol for a Randomized, Controlled, Multicenter Study. JMIR Res Protoc. 2018 Aug 24;7(8):e11294. doi: 10.2196/11294.

Reference Type: DERIVED

PMID: 30143474 (View on PubMed)

Other Identifiers

ZRHR-ERS-09-US

Identifier Type: OTHER

Identifier Source: secondary_id

ZRHR-ERS-09-US

Identifier Type: -

Identifier Source: org_study_id