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

Smoking Clinical Trial

Official title:

A 26-week Extension Study to Determine the Biological and Functional Changes in Healthy Smokers Who Switched From Conventional Cigarettes (CC) to Tobacco Heating System 2.2 (THS 2.2) Compared to Those Who Continued to Smoke CC in the ZRHR-ERS-09-US Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02649556
• Other study ID #: ZRHR-ERS-09-EXT-US
• Secondary ID: ZRHR-ERS-09-EXT-
• Status: Completed
• Phase: N/A
• Start date: September 30, 2015
• Est. completion date: December 20, 2017

Study information

• Verified date: November 2020
• Source: Philip Morris Products S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 672
• Est. completion date: December 20, 2017
• Est. primary completion date: March 13, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years and older

Eligibility

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.

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

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	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, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Levels of High Density Lipoprotein C (HDL-C).	Concentrations (mg/dL) measured in serum. Mean values are provided as descriptive statistics.	52 weeks
Primary	Levels of White Blood Cells (WBC).	Total count in blood (GI/L). Mean values are provided as descriptive statistics.	52 weeks
Primary	Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1).	FEV1 post-bronchodilator and expressed as percentage predicted (FEV1 %pred). Mean values are provided as descriptive statistics.	52 weeks
Primary	Concentrations of Soluble Intercellular Adhesion Molecule 1 (sICAM-1).	Concentrations (ng/mL) measured in serum. Geometric Mean values are provided as descriptive statistics.	52 weeks
Primary	Concentrations of 11-dehydrothromboxane B2 (11-DTXB2).	Concentrations measured in urine and expressed as concentration adjusted for creatinine (pg/mg creat). Geometric Mean values are provided as descriptive statistics.	52 weeks
Primary	Concentrations of 8-epi-prostaglandin F2a (8-epi-PGF2a).	Concentrations measured in urine and expressed as concentration adjusted for creatinine (pg/mg creat). Geometric Mean values are provided as descriptive statistics.	52 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 (pg/mg creat). Geometric Mean values are provided as descriptive statistics.	52 weeks
Primary	Levels of Carboxyhemoglobin (COHb).	Carboxyhemoglobin (COHb) is assayed from whole blood. Expressed as % of saturation of hemoglobin. Geometric Mean values are provided as descriptive statistics.	52 weeks