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
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|ClinicalTrials.gov Identifier: NCT02649556|
Recruitment Status : Completed
First Posted : January 7, 2016
Results First Posted : December 4, 2020
Last Update Posted : December 4, 2020
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|Condition or disease||Intervention/treatment||Phase|
|Smoking||Other: THS 2.2 Other: CC||Not Applicable|
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||672 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||September 30, 2015|
|Actual Primary Completion Date :||March 13, 2017|
|Actual Study Completion Date :||December 20, 2017|
Experimental: THS 2.2
Ad libitum use of THS 2.2
Other: THS 2.2
Ad libitum use of THS 2.2 in an ambulatory setting for 26 weeks.
Active Comparator: CC
Ad libitum use of 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.
- 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.
- Levels of White Blood Cells (WBC). [ Time Frame: 52 weeks ]Total count in blood (GI/L). Mean values are provided as descriptive statistics.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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|Ages Eligible for Study:||30 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02649556
|Study Chair:||Christelle Haziza, PhD||Philip Morris Products S.A.|
|Principal Investigator:||Danielle Armas, MD||Celerion Arizona|
|Principal Investigator:||Leonard Dunn, MD||Clinical Research West Florida|
|Principal Investigator:||Hugh Coleman, MD||Covance|
|Principal Investigator:||George Stoica, MD||Compass Research|
|Principal Investigator:||Mark Adams, MD||Central Kentucky Research Associate|
|Principal Investigator:||Peter Davidson, MD||Celerion Lincoln|
|Principal Investigator:||John Rubino, MD||PMG Research of Raleigh|
|Principal Investigator:||George Raad, MD||PMG Research of Charlotte|
|Principal Investigator:||Kevin Cannon, MD||PMG Research of Wilmington|
|Principal Investigator:||Derek Schroder, MD||PMG Research of Cary|
|Principal Investigator:||Stephanie Powell, MD||PMG Research of Bristol|
|Principal Investigator:||William Smith, MD||NOCCR|
|Principal Investigator:||Darrell Herrington, MD||Benchmark|
|Principal Investigator:||Laurence Chu, MD||Benchmark|
|Principal Investigator:||William Seger, MD||Benchmark|
|Principal Investigator:||David Subich, MD||Compass Research|
|Principal Investigator:||Lon Lynn, MD||Clinical Research West Florida|
|Principal Investigator:||Isabel Kuhare-Arcure, MD||Midwest Clinical Research|
|Principal Investigator:||Keith Scott, MD||National Clinical Research|
Documents provided by Philip Morris Products S.A.:
|Responsible Party:||Philip Morris Products S.A.|
|Other Study ID Numbers:||
ZRHR-ERS-09-EXT-US ( Other Identifier: Philip Morris Products S.A. )
|First Posted:||January 7, 2016 Key Record Dates|
|Results First Posted:||December 4, 2020|
|Last Update Posted:||December 4, 2020|
|Last Verified:||November 2020|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Modified risk tobacco product
Tobacco Heating System