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NCT Number: 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

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.

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Key information

Conditions

Smoking Behavior

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Celerion Arizona, Tempe, Arizona, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

THS 2.2

Other

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

CC

Other

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.

Primary outcomes

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

    Time frame: 52 weeks

    Concentrations (mg/dL) measured in serum. Mean values are provided as descriptive statistics.

  2. Levels of White Blood Cells (WBC).

    Time frame: 52 weeks

    Total count in blood (GI/L). Mean values are provided as descriptive statistics.

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

    Time frame: 52 weeks

    FEV1 post-bronchodilator and expressed as percentage predicted (FEV1 %pred). Mean values are provided as descriptive statistics.

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

    Time frame: 52 weeks

    Concentrations (ng/mL) measured in serum. Geometric Mean values are provided as descriptive statistics.

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

    Time frame: 52 weeks

    Concentrations measured in urine and expressed as concentration adjusted for creatinine (pg/mg creat). Geometric Mean values are provided as descriptive statistics.

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

    Time frame: 52 weeks

    Concentrations measured in urine and expressed as concentration adjusted for creatinine (pg/mg creat). Geometric Mean values are provided as descriptive statistics.

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

    Time frame: 52 weeks

    Concentrations measured in urine and expressed as concentration adjusted for creatinine (pg/mg creat). Geometric Mean values are provided as descriptive statistics.

  8. Levels of Carboxyhemoglobin (COHb).

    Time frame: 52 weeks

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

Sponsors and collaborators

Lead sponsor

Philip Morris Products S.A.

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jan 7, 2016
Registry last updated
Dec 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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