Tobacco Use DisorderNCT00740896
Acute Effects of Smoking on Airway Dendritic Cells
A study testing Smoking in people with Tobacco Use Disorder, run by University of Rostock at 1 site in Germany.
Trial summary
Airway dendritic cells control pulmonary immune responses to inhaled particles. It is the aim of the present study to investigate the acute effects of smoking on the number and surface molecule expression of human airway dendritic cells. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use Disorder
- What is being tested?
- Smoking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2008to Dec 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Active smoking (at least 10 cigarettes per day)
- Age > 18 years
Who cannot join
- Any chronic diseases
- Any regular medication
- Any signs or symptoms of an acute infection
Trial locations and contacts
1 site in 1 country.
About this study
Airway dendritic cells control pulmonary immune responses to inhaled particles. It is the aim of the present study to investigate the acute effects of smoking on the number and surface molecule expression of human airway dendritic cells.
- Conditions
- Tobacco Use Disorder
- Being tested
- Smoking
- Keywords
- Cigarette Smoking, Airway dendritic cells
- Medical subject headings
- Tobacco Use Disorder, Cigarette Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SmokingBehavioural
Active Comparator: Participants smoke 8 cigarettes in 4 hours.
SmokingBehavioural
Sham Comparator: Participants are not allowed to smoke for 4 hours.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Participants smoke 8 cigarettes in 4 hours. Receives: Behavioral: Smoking |
| 2 | Sham comparator | Participants are not allowed to smoke for 4 hours. Receives: Behavioral: Smoking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total number of dendritic cells in bronchoalveolar lavage fluid
Measured: June - September 2008
Secondary outcomes (1)
Surface molecule expression on dendritic cells in bronchoalveolar lavage fluid
Measured: June - September 2008
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2008 (estimated)
- Study startJun 2008
- Primary completionNov 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tobacco Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rostock
- Sponsor type
- University, hospital or other
- Collaborators
- German Research Foundation
- Investigators
- Johann C. Virchow, Professor, MD, FRCP, FCCP, Study chair, University of Rostock
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00740896
- Sponsor's protocol ID
- LO-2222
- Status last verified
- Apr 2009
- First submitted
- 22 Aug 2008
- Last updated
- 8 Apr 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Bratke K, Klug M, Bier A, Julius P, Kuepper M, Virchow JC, Lommatzsch M. Function-associated surface molecules on airway dendritic cells in cigarette smokers. Am J Respir Cell Mol Biol. 2008 Jun;38(6):655-60. doi: 10.1165/rcmb.2007-0400OC. Epub 2008 Jan 18.
PubMed 18203971
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Smoking on Airway Dendritic Cells
- ClinicalTrials.gov ID
- NCT00740896
- Acronym / sponsor ID
- LO-2222
- Conditions
- Tobacco Use Disorder
- Keywords
- Cigarette Smoking, Airway dendritic cells
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of RostockUniversity, hospital or other
- Collaborators
- German Research Foundation
- Study start
- Jun 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 25 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Airway dendritic cells control pulmonary immune responses to inhaled particles. It is the aim of the present study to investigate the acute effects of smoking on the number and surface molecule expression of human airway dendritic cells.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: SmokingParticipants smoke 8 cigarettes in 4 hours. |
| 2 | Sham comparator | Behavioral: SmokingParticipants are not allowed to smoke for 4 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Active smoking (at least 10 cigarettes per day)
- Age > 18 years
Key exclusion criteria (3 listed)
- Any chronic diseases
- Any regular medication
- Any signs or symptoms of an acute infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SmokingActive Comparator: Participants smoke 8 cigarettes in 4 hours. | Behavioural | 1 |
| SmokingSham Comparator: Participants are not allowed to smoke for 4 hours. | Behavioural | 2 |
Primary outcome
Total number of dendritic cells in bronchoalveolar lavage fluid
Time frame: June - September 2008
1 secondary outcome
Surface molecule expression on dendritic cells in bronchoalveolar lavage fluid
Time frame: June - September 2008
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2009.
- Background: PubMed 18203971Bratke K, Klug M, Bier A, Julius P, Kuepper M, Virchow JC, Lommatzsch M. Function-associated surface molecules on airway dendritic cells in cigarette smokers. Am J Respir Cell Mol Biol. 2008 Jun;38(6):655-60. doi: 10.1165/rcmb.2007-0400OC. Epub 2008 Jan 18.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johann C. Virchow, Professor, MD, FRCP, FCCP study chair
University of Rostock
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smoking in people with Tobacco Use Disorder, run by University of Rostock at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total number of dendritic cells in bronchoalveolar lavage fluid (time frame: June - September 2008). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00740896, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2009.