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

NCT02396381 | Completed Results

• 1 other identifier: ZRHR-ERS-09-US
• Study Type: interventional
• Target: 1,039
• Locations: 1 country
• Sites: 19

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.

Conditions

Smoking

Keywords

Candidate modified risk tobacco product; Conventional cigarette; Exposure response; Smoking; Tobacco Heating System

Outcome Measures

Primary Outcomes (8)

• Levels of High Density Lipoprotein C (HDL-C).

  Concentrations measured in serum. Geometric Least Squares means are provided as descriptive statistics.

  26 Weeks

• Levels of White Blood Cells (WBC).

  Concentrations measured in blood. Geometric Least Squares means are provided as descriptive statistics.

  26 Weeks

• Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1).

  FEV1 post-bronchodilator and expressed as percentage predicted (FEV1 %pred). Geometric Least Squares means are provided as descriptive statistics.

  26 Weeks

• Concentrations of Soluble Intercellular Adhesion Molecule 1 (sICAM-1).

  Concentrations measured in serum. Geometric Least Squares means are provided as descriptive statistics.

  26 Weeks

• Concentrations of 11-dehydrothromboxane B2 (11-DTXB2).

  Concentrations measured in urine and expressed as concentration adjusted for creatinine. Geometric Least Squares means are provided as descriptive statistics.

  26 Weeks

• Concentrations of 8-epi-prostaglandin F2α (8-epi-PGF2α).

  Concentrations measured in urine and expressed as concentration adjusted for creatinine. Geometric Least Squares means are provided as descriptive statistics.

  26 Weeks

• Concentrations of Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL).

  Concentrations measured in urine and expressed as concentration adjusted for creatinine. Geometric Least Squares means are provided as descriptive statistics.

  26 Weeks

• Percent Change From Baseline of Carboxyhemoglobin (COHb)

  Carboxyhemoglobin (COHb) is assayed from whole blood. Geometric Least Squares means are provided as descriptive statistics. Expressed as % of saturation of hemoglobin.

  26 Weeks

Study Arms (2)

THS 2.2

EXPERIMENTAL

Ad libitum use of THS 2.2

Other: THS 2.2

CC

ACTIVE COMPARATOR

Ad libitum use of CC

Other: CC

Interventions

THS 2.2 OTHER

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

THS 2.2

CC OTHER

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

CC

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Philip Morris Products S.A.: lead

Study Sites (19)

Celerion Arizona

Tempe, Arizona, 85283, United States

Location

Clinical Research West Florida

Clearwater, Florida, 33765, United States

Location

Covance, Inc

Daytona Beach, Florida, 32117, United States

Location

Compass Research

Orlando, Florida, 32806, United States

Location

Clinical Research West Florida

Tampa, Florida, 33603, United States

Location

Compass Research

The Villages, Florida, 32162, United States

Location

Central Kentucky Research Associate

Lexington, Kentucky, 40509, United States

Location

Celerion Lincoln

Lincoln, Nebraska, 68502, United States

Location

PMG Research of Cary

Cary, North Carolina, 27518, United States

Location

PMG Research of Charlotte

Charlotte, North Carolina, 28209, United States

Location

PMG Research of Raleigh

Raleigh, North Carolina, 27609, United States

Location

PMG Research of Wilmington

Wilmington, North Carolina, 28401, United States

Location

Midwest Clinical Research Center

Dayton, Ohio, 45417, United States

Location

PMG Research of Bristol

Bristol, Tennessee, 37620, United States

Location

NOCCR

Knoxville, Tennessee, 37920, United States

Location

Benchmark

Austin, Texas, 78705, United States

Location

Benchmark

Fort Worth, Texas, 76135, United States

Location

Benchmark

San Angelo, Texas, 76904, United States

Location

National Clinical Research

Richmond, Virginia, 23294, United States

Location

Related Publications (2)

• 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.

  PMID: 31270101 RESULT

• 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.

  PMID: 30143474 DERIVED

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

• Title: Christelle Haziza
• Organization: Philip Morris Products S.A.

ClinicalTrials.PMI@pmi.com

+41 58 242 11 11

Study Officials

• Christelle Haziza, PhD

  Philip Morris Products S.A.

  STUDY CHAIR

• Danielle Armas, MD

  Celerion Arizona

  PRINCIPAL INVESTIGATOR

• Leonard Dunn, MD

  Clinical Research West Florida

  PRINCIPAL INVESTIGATOR

• Hugh Coleman, MD

  Covance

  PRINCIPAL INVESTIGATOR

• George Stoica, MD

  Compass Research

  PRINCIPAL INVESTIGATOR

• Mark Adams, MD

  Central Kentucky Research Associate

  PRINCIPAL INVESTIGATOR

• Peter Davidson, MD

  Celerion Lincoln

  PRINCIPAL INVESTIGATOR

• John Rubino, MD

  PMG Research of Raleigh

  PRINCIPAL INVESTIGATOR

• George Raad, MD

  PMG Research of Charlotte

  PRINCIPAL INVESTIGATOR

• Kevin Cannon, MD

  PMG Research of Wilmington

  PRINCIPAL INVESTIGATOR

• Derek Schroder, MD

  PMG Research of Cary

  PRINCIPAL INVESTIGATOR

• Stephanie Powell, MD

  PMG Research of Bristol

  PRINCIPAL INVESTIGATOR

• William Smith, MD

  NOCCR

  PRINCIPAL INVESTIGATOR

• Darrell Herrington, MD

  Benchmark

  PRINCIPAL INVESTIGATOR

• Laurence Chu, MD

  Benchmark

  PRINCIPAL INVESTIGATOR

• William Seger, MD

  Benchmark

  PRINCIPAL INVESTIGATOR

• Lon Lynn, MD

  Clinical Research West Florida

  PRINCIPAL INVESTIGATOR

• David Subich, MD

  Compass Research

  PRINCIPAL INVESTIGATOR

• Isabel Kuhare-Arcure, MD

  Midwest Clinical Research

  PRINCIPAL INVESTIGATOR

• Keith Scott, MD

  National Clinical Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2015
• First Posted: March 24, 2015
• Study Start: March 12, 2015
• Primary Completion: September 13, 2016
• Study Completion: August 1, 2017
• Last Updated: January 26, 2023
• Results First Posted: August 21, 2019

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (19)