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Terminated NCT05598125

Study of Vascular Function Before vs After Smoking an E-cigarette as Compared to a Normal Cigarette

Conditions: Endothelial Function

Sex: Male
Ages: 22 Years – 35 Years
Healthy volunteers: 1
Enrollment: 64
Sponsor: GWT-TUD GmbH

Summary

Investigation of the effect of one-time use of an electronic e-cigarette in comparison to smoking a conventional cigarette on in vivo conduit endothelial function in healthy long-term smokers

Eligibility Criteria

Inclusion Criteria:• Subjects must be males between 22 and 35 years of age, inclusive.Subjects must be able to comprehend, sign and date a written informed consent prior to entering the study.Subjects must be willing and able to comply with the protocol requirements for the duration of the study.Subjects must have experienced one of the following:Smoked for at least the last 4 years and at least 5 cigarettes a day or 1 pack-years,Never having regularly smoked, i.e. < 20 cigarettes in their lifetime and not in last 5 years.Exclusion Criteria:Consumption of cigars, other tobacco and nicotine products and light-cigarettes (less than 8 mg ISO tar).Exhaled CO levels < 10 ppm (smokers) and ≥ 10 ppm (never smokers).Urinary cotinine < 200 ng/ml for smoker groupTreatment for arterial hypertension, or clinic blood pressure ≥140/90 mmHg.Body mass index ≥ 30 kg/m2Ocular diseases, glaucoma.Convulsive disorder/epilepsy or intake of anticonvulsant drugs.Subjects with a clinically significant or unstable medical or surgical condition that would preclude safe and complete study participation, as determined by medical history, physical exams, ECG, abnormal laboratory tests. Such conditions may include hepatic, renal or metabolic diseases, systemic disease, acute infection, current malignancy or recent history (5 years) of malignancy, major psychiatric disorder, history of drug and/or alcohol abuse and allergies that could be detrimental according to the investigator's judgment.Prior participation in a clinical study in last 4 weeks.Intake of drugs with potential impact on the endothelial function resp. autonomic nervous system.Known intolerance against salbutamol, nitroglycerin and/or propylene glycol.Regular intake of vitamins and mineral supplements.Heavy exercisers and trained athletes (> 5 hours physical activity / week).

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05598125). StuddyBuddy aggregates publicly available trial information.