N/A
Completed N=857
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
Source: ClinicalTrials.gov NCT02649556 ↗Enrolled (actual)
857
Serious AEs
3.1%
Results posted
Dec 2020
Primary outcomePrimary: Levels of High Density Lipoprotein C (HDL-C). — 52.2; 50.6; 54.0; 54.7 mg/dL
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Levels of High Density Lipoprotein C (HDL-C). |
52.2; 50.6; 54.0; 54.7 | — |
| PRIMARY Levels of White Blood Cells (WBC). |
6.73; 7.31; 7.28; 7.57 | — |
| PRIMARY Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1). |
93.2; 92.3; 91.1; 95.2 | — |
| PRIMARY Concentrations of Soluble Intercellular Adhesion Molecule 1 (sICAM-1). |
246; 258; 269; 255 | — |
| PRIMARY Concentrations of 11-dehydrothromboxane B2 (11-DTXB2). |
582; 586; 595; 536 | — |
| PRIMARY Concentrations of 8-epi-prostaglandin F2α (8-epi-PGF2α). |
307; 327; 326; 364 | — |
| PRIMARY Concentrations of Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL). |
133; 269; 253; 304 | — |
| PRIMARY Levels of Carboxyhemoglobin (COHb). |
2.59; 4.06; 3.92; 5.22 | — |
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.
Data sourced from ClinicalTrials.gov (NCT02649556). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.