Condition category
Injury, Occupational Diseases, Poisoning
Date applied
06/03/2009
Date assigned
10/03/2009
Last edited
11/01/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Chris Proctor

ORCID ID

Contact details

Chief Scientific Officer
British American Tobacco (Investments) Ltd
GR&D Centre
Regent's Park Road
Southampton
Hampshire
SO15 8TL
United Kingdom
+44 (0)2380 588279
christopher_proctor@bat.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RTP Study Protocol 3865

Study information

Scientific title

A single-blinded, controlled study to evaluate the effects of a novel cigarette on biomarkers of exposure, filter analysis and sensory tests, when used by healthy smokers

Acronym

Study hypothesis

When smokers switch from conventional cigarettes to novel cigarettes of equivalent International Organization for Standardization (ISO) tar yield but with lower levels of selected smoke toxicants as determined by smoking machines, there is a measurable change in level of exposure to those same toxicants, as determined by biomarkers of exposure and filter analysis methods.

Ethics approval

Ethics Committee of Arztekramer Hamburg, approved on 11/12/2008.

Study design

Interventional non-randomised single-centre single-blinded switching study

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a Subject Information Sheet

Condition

Exposure to cigarette toxicants

Intervention

The 6 weeks clinical trial will be conducted as per the principles of good clinical practice. The safety of the subjects participating in the study will be evaluated prior to and post study.

The study will be performed in two parts, commencing with the smokers of the 6 mg ISO tar yield cigarettes and the non-smokers in parallel (part 1), followed by the smokers of the 1 mg ISO tar yield cigarettes (part 2). During the first 2 weeks of their involvement in the study, smokers will smoke a supplied commercial brand with ISO tar yield equivalent to the novel cigarette. On day 15 of each study period, the 6 mg ISO tar yield smokers will be split into two cohorts and the 1 mg ISO tar yield smokers will be split into three cohorts. The allocation of the participants in the two groups into smaller cohorts will be done consecutively (non-randomised allocation). One cohort in each group will continue to smoke the supplied commercial brand while the other cohorts will be switched to smoke the novel cigarettes for subsequent 4 weeks. Participants will be instructed to smoke as per their normal smoking behaviour (no minimum or maximum limits on amount smoked) throughout the interventions.

Company identifiers of the novel cigarettes: German Reduced Toxicant Products F752, H671 and T562

During the 6 weeks study period the following procedures will be performed:
1. Urine collection for biomarkers of exposure, exhaled CO at 2, 4 and 6 weeks
2. Saliva collection for cotinine assay on all ambulatory visits and each day resident in the clinic.
3. Blood sample collection prior to switching for genotyping and gene expression, and at the end of 6th week for gene expression only
4. Cigarette filter tips collection every 7 days and on each day of stay in the clinic to assess mouth level exposure of whole smoke
5. Regular collection of all smoked cigarette butts for accountability
6. Sensory perception assessment prior to switching, immediately at the end of first day after switching, end 6th week
7. SF-36® health survey questionnaire prior to switching and at the end of 6th week
8. Smoking Behaviour assessment by means of Smoking Analyser (SA7) and life shirt jacket at 2 and 4 weeks
9. Medical history, physical examination, pulmonary function test, vital signs, ECG at screening, end of 2nd, 4th and 6th week
10. Alcohol breath test and urine drug screen at screening and every 2 weeks
11. Routine safety assessment at screening and at the end of study period
12. Adverse event recording will be done at regular intervals

Principal Investigator:
Dr. Ingo Meyer
Medical Director
Momentum Pharma Services GmbH

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

To estimate and compare cigarette smoke exposure in healthy adult smokers using both biomarkers of exposure and filter analysis and to quantify any changes in these exposure estimates following a switch from commercial to novel cigarettes. Data collection will be carried out as follows:
1. Urine collection for biomarkers of exposure, exhaled CO at 2, 4 and 6 weeks
2. Cigarette filter tips collection every 7 days and on each day of stay in the clinic to assess mouth level exposure of whole smoke

Secondary outcome measures

1. To determine changes in the following measures during consumption of novel cigarettes and commercial cigarettes:
1.1. Sensory perception questionnaire prior to switching, immediately at the end of first day after switching, end of 6th week
1.2. Smoking behaviour including puffing and inhalation behaviour, assessed by Smoking Analyser (SA7) and life shirt jacket at 2 and 4 weeks
1.3. Quality of life using SF-36® Health Survey prior to switching and at the end of 6th week
1.4. Basic physiological measures: medical history, physical examination, pulmonary function test, vital signs, ECG at screening, end of 2nd, 4th and 6th week

2. To analyse genotype and gene expression to support the interpretation of the biomarkers of exposure:
2.1. Blood sample collection prior to switching for genotyping and gene expression, and at the end of 6th week for gene expression only

Overall trial start date

01/02/2009

Overall trial end date

31/08/2009

Reason abandoned

Eligibility

Participant inclusion criteria

The study would enrol 250 healthy adult habitual smokers of 6-7 mg (N = 100) and 1-2 mg (N = 150) ISO tar yield cigarettes and 50 healthy adult non-smokers to take part in the study.

Inclusion criteria for all participants:
1. Subjects of either sex, of any ethnic origin, 21 years of age or older
2. No clinically significant abnormal findings, as judged by the Principal Investigator, on the physical examination, electrocardiogram (ECG), clinical laboratory test results, lung function tests or medical history during screening
3. Voluntarily provide written Informed Consent and demonstrate ability to comprehend the Informed Consent Form
4. Refrain from consuming methylxanthine-containing products (e.g. caffeine) within 24 hours of the first day of each confinement visit
5. Refrain from consuming alcohol from 72 hours prior to the first day of each confinement visit.
6. Female subjects must have negative urine pregnancy test at screening. Other acceptable criteria for including women would be sexual abstinence (provided it is the preferred and usual lifestyle of the subject); women not of child bearing potential (tubal occlusion, hysterectomy, bilateral salpingectomy)

Additional inclusion criteria for smoking groups:
7. Regular smokers whose chosen brand is both within one of the required ISO tar bands and have blend style/mechanics that are typical of the German market
8. Smokers smoking their chosen brand for a minimum of 6 months and have smoked for at least 3 years prior to screening
9. Typically smoke between 6 and 30 cigarettes per day
10. Subjects willing to switch to a novel cigarette

Additional inclusion criteria for non-smoking groups:
11. Individuals who have not smoked for at least five years and have a urinary continine level of <10 ng/ml

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

300 (250 smokers and 50 non-smokers)

Participant exclusion criteria

1. Clinically relevant gastrointestinal, renal, hepatic, neurologic, haematologic, endocrine, oncologic, urologic, pulmonary, immunologic, psychiatric, or cardiovascular disease or any other health condition
2. Clinically relevant abnormal findings on the physical examination, medical history, or clinical laboratory results unless deemed not clinically significant by the Principal Investigator
3. History of participation in clinical trial within 90 days prior to screening
4. History of 400 mL or more blood loss within 90 days prior to screening
5. Acute illness (e.g., upper respiratory tract infection, viral infection, etc.) requiring treatment within 4 weeks prior to enrolment
6. History of drug or alcohol abuse
7. Positive alcohol breath test and urine screen for drugs of abuse (amphetamines, barbiturates, benzodiazepines, cocaine, ecstasy, methamphetine, morphine, methadone, tricyclic antidepressants [TCA] and marijuana [THC]).
8. Positive HIV or hepatitis screen (checked only at screening)
9. History of use of bronchodilator medication (e.g., inhaled or oral beta-agonists) within the 12 months prior to study enrolment
10. History of chronic medication which interferes with the cyclooxygenase pathway (anti-inflammatory drugs such as aspirin or ibuprofen)
11. Any prescribed chronic systemic medication within 14 days of enrolment (except for hormonal contraceptive and hormone replacement therapy)
12. History of intake of drugs or substances known to be inducers of cytochrome P450 enzymes within 28 days prior to screening
13. Women of child bearing potential who fail to use any reliable contraception.
14. Pregnant or lactating women
15. Smokers of cigarettes that are not within the required ISO tar bands or smoke cigarettes that have been identified as atypical of the German Market with respect to blend style and mechanics
16. Smokers who smoke less than 6 and more than 30 cigarettes per day
17. Smokers consuming any nicotine or tobacco products other than filter cigarettes
18. Smokers who are known to only take puffs of smoke without inhaling or observed with similar smoking pattern during the study
19. Non-smokers with levels of cotinine >10 ng/ml in their urine test
20. Employees of the tobacco industry, journalism, TV and radio reporting, public relations, market research and advertising

Recruitment start date

01/02/2009

Recruitment end date

31/08/2009

Locations

Countries of recruitment

Germany

Trial participating centre

Chief Scientific Officer
Hampshire
SO15 8TL
United Kingdom

Sponsor information

Organisation

British American Tobacco (Investments) Ltd (UK)

Sponsor details

GR&D Centre
Regent's Park Road
Southampton
Hampshire
SO15 8TL
United Kingdom
+44 (0)2380 793715
christopher_proctor@bat.com

Sponsor type

Industry

Website

http://www.bat-science.com

Funders

Funder type

Industry

Funder name

British American Tobacco (Investments) Ltd (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes