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Recruiting NCT07625111

Effect of Smoking and Time of Day on Eosinophils

No phase Interventional Healthy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Smoking for 4 hours.
Who it may be relevant to
Registry conditions: Healthy. Basic parameters: 18 years — 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Effects of Acute Smoking and Time of Day on Blood Eosinophils in Humans

Overview

The study investigates the effect of acute smoking and time of day on blood eosinophils in chronic smokers. Chronic cigarette smokers without chronic respiratory diseases smoking at least 8 cigarettes per day and never-smoking controls are examined. Blood eosinophil counts and surface molecules are measured at 8 and 12 am in both groups. In smokers, two measurements are performed (at least 4 weeks apart): one measurement with no smoking between 8 and 12 am, and another measurement with smoking of 8 cigarettes between 8 and 12 am.

Detailed description

20 chronic cigarette smokers without chronic respiratory diseases smoking at least 8 cigarettes per day and 20 never-smoking controls are recruited. Blood eosinophil counts and surface molecules are measured at 8 and 12 am in both groups. In smokers, two measurements are performed (at least 4 weeks apart, cross-over design): one measurement with no smoking between 8 and 12 am, and another measurement with smoking of 8 cigarettes between 8 and 12 am. The effects of the time of day (comparing 8 and 12 am) and the effects of acute smoking (comparing the effects of no smoking or acute smoking at 12 am) on blood eosinophil counts and surface molecules (using flow cytometry) are analyzed. Additional parameters examined: lung function, exhaled nitric oxide, total and specific IgE in serum.

Interventions

  • Other Smoking for 4 hours
    Smoking of 8 cigarettes in 4 hours

Primary outcome measures

  • Blood eosinophil counts [Time frame: 8 am (baseline) and 12 am (follow-up after intervention)]
Secondary outcome measures (1)
  • Blood eosinophil surface molecules [Time frame: 8 am (baseline) and 12 am (follow-up after intervention)]

Eligibility criteria

Inclusion criteria

  • Healthy current smokers
  • Age between 18-50 years
  • Smoking of at least 8 cigarettes/day

Exclusion criteria

  • Chronic respiratory diseases
  • Any treatment with corticosteroids or other immunosuppressants
  • Any acute illness

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Basic science

Study locations

Germany · 1 center
  • University of Rostock — Rostock

Identifiers

NCT: NCT07625111 · Smoke-Time-Eosinophils

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗