NCT02649556

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
672

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2015

Typical duration for not_applicable

Geographic Reach
1 country

19 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 30, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 5, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 7, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 13, 2017

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2017

Completed
3 years until next milestone

Results Posted

Study results publicly available

December 4, 2020

Completed
Last Updated

December 4, 2020

Status Verified

November 1, 2020

Enrollment Period

1.5 years

First QC Date

January 5, 2016

Results QC Date

May 25, 2020

Last Update Submit

November 10, 2020

Conditions

Smoking

Keywords

Modified risk tobacco productConventional cigaretteExposure responseSmokingTobacco Heating System

Outcome Measures

Primary Outcomes (8)

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

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

    52 weeks

  • Levels of White Blood Cells (WBC).

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

    52 weeks

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

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

    52 weeks

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

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

    52 weeks

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

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

    52 weeks

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

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

    52 weeks

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

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

    52 weeks

  • Levels of Carboxyhemoglobin (COHb).

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

    52 weeks

Study Arms (2)

THS 2.2

EXPERIMENTAL

Ad libitum use of THS 2.2

Other: THS 2.2

CC

ACTIVE COMPARATOR

Ad libitum use of CC

Other: CC

Interventions

THS 2.2OTHER

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

THS 2.2
CCOTHER

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.

CC

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

Celerion Arizona

Tempe, Arizona, 85283, United States

Location

Clinical Research West Florida

Clearwater, Florida, 33765, United States

Location

Covance, Inc

Daytona Beach, Florida, 32117, United States

Location

Compass Research

Orlando, Florida, 32806, United States

Location

Clinical Research West Florida

Tampa, Florida, 33603, United States

Location

Compass Research

The Villages, Florida, 32162, United States

Location

Central Kentucky Research Associate

Lexington, Kentucky, 40509, United States

Location

Celerion Lincoln

Lincoln, Nebraska, 68502, United States

Location

PMG Research of Cary

Cary, North Carolina, 27518, United States

Location

PMG Research of Charlotte

Charlotte, North Carolina, 28209, United States

Location

PMG Research of Raleigh

Raleigh, North Carolina, 27609, United States

Location

PMG Research of Wilmington

Wilmington, North Carolina, 28401, United States

Location

Midwest Clinical Research

Dayton, Ohio, 45417, United States

Location

PMG Research of Bristol

Bristol, Tennessee, 37620, United States

Location

NOCCR

Knoxville, Tennessee, 37920, United States

Location

Benchmark

Austin, Texas, 78705, United States

Location

Benchmark

Fort Worth, Texas, 76135, United States

Location

Benchmark

San Angelo, Texas, 76904, United States

Location

National Clinical Research

Richmond, Virginia, 23294, United States

Location

Related Publications (1)

  • Ansari SM, Hession PS, David M, Blanc N, de La Bourdonnaye G, Pouly S, Haziza C. Impact of switching from cigarette smoking to tobacco heating system use on biomarkers of potential harm in a randomized trial. Biomarkers. 2024 Jul;29(5):298-314. doi: 10.1080/1354750X.2024.2358318. Epub 2024 Jun 7.

    PMID: 38804903DERIVED

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

Title
Christelle Haziza
Organization
Philip Morris Products S.A.
christelle.haziza@pmi.com
+41 58 242 11 11

Study Officials

  • Christelle Haziza, PhD

    Philip Morris Products S.A.

    STUDY CHAIR

  • 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

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2016

First Posted

January 7, 2016

Study Start

September 30, 2015

Primary Completion

March 13, 2017

Study Completion

December 20, 2017

Last Updated

December 4, 2020

Results First Posted

December 4, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

US(19)