Clinical trial NCT02649556: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Keywords: Modified risk tobacco product
Conventional cigarette
Exposure response
Smoking
Tobacco Heating System
Lead sponsor: Philip Morris Products S.A.
Sponsor class: INDUSTRY
First posted: 2016-01-07
Enrollment: 672
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Detailed 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Levels of High Density Lipoprotein C (HDL-C).
timeFrame: 52 weeks
measure: Levels of White Blood Cells (WBC).
timeFrame: 52 weeks
measure: Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1).
timeFrame: 52 weeks
measure: Concentrations of Soluble Intercellular Adhesion Molecule 1 (sICAM-1).
timeFrame: 52 weeks
measure: Concentrations of 11-dehydrothromboxane B2 (11-DTXB2).
timeFrame: 52 weeks
measure: Concentrations of 8-epi-prostaglandin F2α (8-epi-PGF2α).
timeFrame: 52 weeks
measure: Concentrations of Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL).
timeFrame: 52 weeks
measure: Levels of Carboxyhemoglobin (COHb).
timeFrame: 52 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Celerion Arizona
state: Arizona
city: Clearwater
country: United States
facility: Clinical Research West Florida
state: Florida
city: Daytona Beach
country: United States
facility: Covance, Inc
state: Florida
city: Orlando
country: United States
facility: Compass Research
state: Florida
city: Tampa
country: United States
facility: Clinical Research West Florida
state: Florida
city: The Villages
country: United States
facility: Compass Research
state: Florida
city: Lexington
country: United States
facility: Central Kentucky Research Associate
state: Kentucky
city: Lincoln
country: United States
facility: Celerion Lincoln
state: Nebraska
city: Cary
country: United States
facility: PMG Research of Cary
state: North Carolina
city: Charlotte
country: United States
facility: PMG Research of Charlotte
state: North Carolina
city: Raleigh
country: United States
facility: PMG Research of Raleigh
state: North Carolina
city: Wilmington
country: United States
facility: PMG Research of Wilmington
state: North Carolina
city: Dayton
country: United States
facility: Midwest Clinical Research
state: Ohio
city: Bristol
country: United States
facility: PMG Research of Bristol
state: Tennessee
city: Knoxville
country: United States
facility: NOCCR
state: Tennessee
city: Austin
country: United States
facility: Benchmark
state: Texas
city: Fort Worth
country: United States
facility: Benchmark
state: Texas
city: San Angelo
country: United States
facility: Benchmark
state: Texas
city: Richmond
country: United States
facility: National Clinical Research
state: Virginia
Study officials:
affiliation: Philip Morris Products S.A.
name: Christelle Haziza, PhD
role: STUDY_CHAIR
affiliation: Celerion Arizona
name: Danielle Armas, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical Research West Florida
name: Leonard Dunn, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Covance
name: Hugh Coleman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Compass Research
name: George Stoica, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Central Kentucky Research Associate
name: Mark Adams, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Celerion Lincoln
name: Peter Davidson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: PMG Research of Raleigh
name: John Rubino, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: PMG Research of Charlotte
name: George Raad, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: PMG Research of Wilmington
name: Kevin Cannon, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: PMG Research of Cary
name: Derek Schroder, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: PMG Research of Bristol
name: Stephanie Powell, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: NOCCR
name: William Smith, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Benchmark
name: Darrell Herrington, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Benchmark
name: Laurence Chu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Benchmark
name: William Seger, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Compass Research
name: David Subich, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical Research West Florida
name: Lon Lynn, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Midwest Clinical Research
name: Isabel Kuhare-Arcure, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Clinical Research
name: Keith Scott, MD
role: PRINCIPAL_INVESTIGATOR
References: