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

Smoking Clinical Trial

Official title:

A Randomized, Controlled, 2-arm Parallel Group, Multi-center Study, to Evaluate Biological and Functional Changes in Healthy Smokers Switching to Tobacco Heating System 2.2 (THS 2.2) Compared to Continuing Smoking Conventional Cigarettes for 26 Weeks in an Ambulatory Setting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02396381
• Other study ID #: ZRHR-ERS-09-US
• Secondary ID: ZRHR-ERS-09-US
• Status: Completed
• Phase: N/A
• Start date: March 12, 2015
• Est. completion date: August 1, 2017

Study information

• Verified date: January 2023
• Source: Philip Morris Products S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1039
• Est. completion date: August 1, 2017
• Est. primary completion date: September 13, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Smoking

Intervention

Other:
• THS 2.2
Ad libitum use of THS 2.2 in an ambulatory setting for 26 weeks
• CC
Ad libitum use of CC in an ambulatory setting for 26 weeks

Locations

Country	Name	City	State
United States	Benchmark	Austin	Texas
United States	PMG Research of Bristol	Bristol	Tennessee
United States	PMG Research of Cary	Cary	North Carolina
United States	PMG Research of Charlotte	Charlotte	North Carolina
United States	Clinical Research West Florida	Clearwater	Florida
United States	Midwest Clinical Research Center	Dayton	Ohio
United States	Covance, Inc	Daytona Beach	Florida
United States	Benchmark	Fort Worth	Texas
United States	NOCCR	Knoxville	Tennessee
United States	Central Kentucky Research Associate	Lexington	Kentucky
United States	Celerion Lincoln	Lincoln	Nebraska
United States	Compass Research	Orlando	Florida
United States	PMG Research of Raleigh	Raleigh	North Carolina
United States	National Clinical Research	Richmond	Virginia
United States	Benchmark	San Angelo	Texas
United States	Clinical Research West Florida	Tampa	Florida
United States	Celerion Arizona	Tempe	Arizona
United States	Compass Research	The Villages	Florida
United States	PMG Research of Wilmington	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Philip Morris Products S.A.

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Levels of High Density Lipoprotein C (HDL-C).	Concentrations measured in serum.; Geometric Least Squares means are provided as descriptive statistics.	26 Weeks
Primary	Levels of White Blood Cells (WBC).	Concentrations measured in blood.; Geometric Least Squares means are provided as descriptive statistics.	26 Weeks
Primary	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
Primary	Concentrations of Soluble Intercellular Adhesion Molecule 1 (sICAM-1).	Concentrations measured in serum.; Geometric Least Squares means are provided as descriptive statistics.	26 Weeks
Primary	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
Primary	Concentrations of 8-epi-prostaglandin F2a (8-epi-PGF2a).	Concentrations measured in urine and expressed as concentration adjusted for creatinine.; Geometric Least Squares means are provided as descriptive statistics.	26 Weeks
Primary	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
Primary	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