- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07625111
Effect of Smoking and Time of Day on Eosinophils
June 1, 2026 updated by: Marek Lommatzsch
Effects of Acute Smoking and Time of Day on Blood Eosinophils in Humans
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Estimated)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Marek Prof. Lommatzsch, Prof.
- Phone Number: +49-381-494-7461
- Email: marek.lommatzsch@med.uni-rostock.de
Study Contact Backup
- Name: Johann C. Virchow, Prof.
- Phone Number: +49-381-494-7461
Study Locations
-
-
-
Rostock, Germany, 18057
- Recruiting
- University of Rostock
-
Contact:
- Marek Prof. Lommatzsch, Prof.
- Phone Number: +49-381-494-7461
- Email: marek.lommatzsch@med.uni-rostock.de
-
Contact:
- Johann C Virchow, Prof.
- Phone Number: +49-381-494-7461
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: A: Smoking of 8 cigarettes in 4 hours
Smoking
|
Smoking of 8 cigarettes in 4 hours
|
|
No Intervention: B: No smoking for 4 hours
No Smoking
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Blood eosinophil counts
Time Frame: 8 am (baseline) and 12 am (follow-up after intervention)
|
Blood eosinophil counts in cells/µl blood
|
8 am (baseline) and 12 am (follow-up after intervention)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Blood eosinophil surface molecules
Time Frame: 8 am (baseline) and 12 am (follow-up after intervention)
|
Blood eosinophil surface molecules (such as CD62L or CD294), measured using flow cytometry
|
8 am (baseline) and 12 am (follow-up after intervention)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 7, 2026
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
December 6, 2026
Study Registration Dates
First Submitted
May 26, 2026
First Submitted That Met QC Criteria
June 1, 2026
First Posted (Actual)
June 4, 2026
Study Record Updates
Last Update Posted (Actual)
June 4, 2026
Last Update Submitted That Met QC Criteria
June 1, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Smoke-Time-Eosinophils
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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