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Completed

NCT Number: NCT02396381

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

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.

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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 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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

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

Primary outcomes

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

    Time frame: 26 Weeks

    Concentrations measured in serum.

    Geometric Least Squares means are provided as descriptive statistics.

  2. Levels of White Blood Cells (WBC).

    Time frame: 26 Weeks

    Concentrations measured in blood.

    Geometric Least Squares means are provided as descriptive statistics.

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

    Time frame: 26 Weeks

    FEV1 post-bronchodilator and expressed as percentage predicted (FEV1 %pred).

    Geometric Least Squares means are provided as descriptive statistics.

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

    Time frame: 26 Weeks

    Concentrations measured in serum.

    Geometric Least Squares means are provided as descriptive statistics.

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

    Time frame: 26 Weeks

    Concentrations measured in urine and expressed as concentration adjusted for creatinine.

    Geometric Least Squares means are provided as descriptive statistics.

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

    Time frame: 26 Weeks

    Concentrations measured in urine and expressed as concentration adjusted for creatinine.

    Geometric Least Squares means are provided as descriptive statistics.

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

    Time frame: 26 Weeks

    Concentrations measured in urine and expressed as concentration adjusted for creatinine.

    Geometric Least Squares means are provided as descriptive statistics.

  8. Percent Change From Baseline of Carboxyhemoglobin (COHb)

    Time frame: 26 Weeks

    Carboxyhemoglobin (COHb) is assayed from whole blood.

    Geometric Least Squares means are provided as descriptive statistics. Expressed as % of saturation of hemoglobin.

Sponsors and collaborators

Lead sponsor

Philip Morris Products S.A.

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Mar 24, 2015
Registry last updated
Jan 26, 2023

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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