smoking
Conditions
Interventions
Group 1: The study was performed with 5 different groups of 10 subjects categorized based on their nicotine product use. Subjects received their individual products at a specific time point prior to r
Sponsors
ABF GmbH
Eligibility
Sex/Gender
All
Age
19 Years to 65 Years
Inclusion criteria
Inclusion criteria: Subjects meeting all of the criteria listed below will be included in the clinical trial: Between 19 and 65 years of age Males and females Physically and mentally healthy, without a legal guardian
Exclusion criteria
Exclusion criteria: Subjects were excluded from the clinical trial without further ado if any of the following criteria were met at screening or at Day -1: • Dual/multiple use of any other nicotine-containing product; • BMI: 33 kg/m2; • Pregnant and/or lactating women; • Drug abusers; • Chronic respiratory or cardiovascular disease like asthma, chronic obstructive pulmonary disease, chronic bronchitis, hypertension (either self-reported or diagnosed by the investigator); • Regular use of medication, excluding hormonal contraceptives and non-prescription pain medication, prior to study inclusion within the last three months or is intended to do so during the study conduct (The definition of regular use of medication will be based on individual physician discretion).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary goal of this research project is to identify suitable biomarkers or biomarker patterns for the evaluation of next-generation nicotine delivery product groups. In a second step, these bi-omarkers or biomarker patterns should be assessed in regard to their suitability for reliably discrim-inating between the different product categories. This aim must be accomplished through the de-velopment of novel untargeted screening methods, by means of chromatographic methods, which are coupled with high-resolution mass-spectrometric-systems. Biological matrices encompass blood, urine, saliva, sputum, exhaled breath and exhaled breath condensate. | — |
Secondary
| Measure | Time frame |
|---|---|
| The quantification of the identified biomarkers (primary objective) will be performed as a secondary objective. The quantification will be accomplished by using chromatographic methods, coupled with mass-spectrometric systems. For several biomarkers of tobacco exposure, targeted methods have already been developed at ABF. | — |
Countries
Germany
Contacts
Public ContactNikola Pluym
ABF GmbH
Outcome results
None listed