Smoke-related Lung DiseasesPhase 1NCT00908362
Impact of Fluticasone and Salmeterol on Airway Dendritic Cells (DCs) in Smokers
A Phase 1 study testing fluticasone and fluticasone/salmeterol in people with Smoke-related Lung Diseases and Chronic Obstructive Pulmonary Disease, run by University of Rostock at 1 site in Germany.
Trial summary
Airway dendritic cells (DCs) play a key role in smoke-related lung diseases. In this study, the researchers investigate the effects of fluticasone and salmeterol on human airway DCs in smokers. Read more about this study
- Who is it for?
- Ages 30 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Smoke-related Lung Diseases, Chronic Obstructive Pulmonary Disease
- What is being tested?
- fluticasone and fluticasone/salmeterol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteGermany
- Study dates
- May 2009to Dec 2009
- Phase
- Phase 1
- 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 30 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men aged 30 - 60 years
- At least 15 years of smoking
- Current smoker, at least 10 cigarettes per day
Who cannot join
- Any acute or chronic disease (except COPD oder hypertension)
- Any regular medication (except drugs against hypertension)
- FEV1 < 80% predicted
- Oxygen saturation < 90%
- Acute infections of the lower respiratory tract in the last 7 days before the first day of the study
Trial locations and contacts
1 site in 1 country.
Germany1 site
Dep. of Pneumology, University of Rostock
Rostock, Mecklenburg-Vorpommern, 18057
About this study
Official title: Investigator Initiated, Placebo Controlled, Randomized Pilot Trial on the Influence of Fluticasone and Salmeterol on Airway Dendritic Cells (DCs) in Smokers With COPD Stage GOLD 0 or 1.
Airway dendritic cells (DCs) play a key role in smoke-related lung diseases. In this study, the researchers investigate the effects of fluticasone and salmeterol on human airway DCs in smokers. The researchers hypothesize that fluticasone and salmeterol impact on the number and the characteristics of airway DCs in smokers.
- Being tested
- fluticasone, fluticasone/salmeterol, placebo
- Keywords
- Dendritic cells, Airway, Smoker, COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluticasoneDrug
Participants inhale fluticasone (250 µg) via discus. Before and after this therapy, a bronchoalveolar lavage is performed.
fluticasone/salmeterolDrug
Participants inhale fluticasone/salmeterol (250/50µg) via discus. Before and after this therapy, a bronchoalveolar lavage is performed.
placeboDrug
Participants inhale placebo twice daily via discus. Before and after this therapy, a bronchoalveolar lavage is performed.
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Inhalation of Fluticasone (via discus) twice daily for 28 days Receives: Drug: fluticasone |
| B | Active comparator | Inhalation of Fluticasone and Salmeterol (via discus) twice daily for 28 days Receives: Drug: fluticasone/salmeterol |
| C | Placebo comparator | Inhalation of Placebo (via discus) twice daily for 28 days. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number and the CCR7 expression of DCs in bronchoalveolar lavage fluid before and after therapy with fluticasone or fluticasone/salmeterol, as compared to placebo.
Measured: 2 time points (A and B). Time point A: day 0 (directly before the inhalation therapy). Time point B: day 29 (directly after the inhalation therapy).
Secondary outcomes (1)
The expression of other surface molecules on DCs in bronchoalveolar lavage fluid before and after therapy with fluticasone or fluticasone/salmeterol, as compared to placebo.
Measured: 2 time points (A and B). Time point A: day 0 (directly before the inhalation therapy). Time point B: day 29 (directly after the inhalation therapy).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2009 (estimated)
- Study startMay 2009
- Primary completionOct 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Smoke-related Lung DiseasesStudies 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rostock
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00908362
- Sponsor's protocol ID
- LO-0003
- Status last verified
- May 2009
- First submitted
- 20 May 2009
- Last updated
- 13 Jan 2010
- 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 18203971Lommatzsch M, Kraeft U, Troebs L, Garbe K, Bier A, Stoll P, Klammt S, Kuepper M, Bratke K, Virchow JC. Fluticasone impact on airway dendritic cells in smokers: a randomized controlled trial. Respir Res. 2013 Oct 29;14(1):114. doi: 10.1186/1465-9921-14-114.
PubMed 24168756
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigator Initiated, Placebo Controlled, Randomized Pilot Trial on the Influence of Fluticasone and Salmeterol on Airway Dendritic Cells (DCs) in Smokers With COPD Stage GOLD 0 or 1.
- ClinicalTrials.gov ID
- NCT00908362
- Acronym / sponsor ID
- LO-0003
- Keywords
- Dendritic cells, Airway, Smoker, COPD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University of RostockUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- May 2009
- Primary completion
- Oct 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 25 May 2009 (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 (DCs) play a key role in smoke-related lung diseases. In this study, the researchers investigate the effects of fluticasone and salmeterol on human airway DCs in smokers. The researchers hypothesize that fluticasone and salmeterol impact on the number and the characteristics of airway DCs in smokers.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: fluticasoneInhalation of Fluticasone (via discus) twice daily for 28 days |
| B | Active comparator | Drug: fluticasone/salmeterolInhalation of Fluticasone and Salmeterol (via discus) twice daily for 28 days |
| C | Placebo comparator | Drug: placeboInhalation of Placebo (via discus) twice daily for 28 days. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Men aged 30 - 60 years
- At least 15 years of smoking
- Current smoker, at least 10 cigarettes per day
Key exclusion criteria (5 listed)
- Any acute or chronic disease (except COPD oder hypertension)
- Any regular medication (except drugs against hypertension)
- FEV1 < 80% predicted
- Oxygen saturation < 90%
- Acute infections of the lower respiratory tract in the last 7 days before the first day of the study
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 |
|---|---|---|
| fluticasoneParticipants inhale fluticasone (250 µg) via discus. Before and after this therapy, a bronchoalveolar lavage is performed. | Drug | A |
| fluticasone/salmeterolParticipants inhale fluticasone/salmeterol (250/50µg) via discus. Before and after this therapy, a bronchoalveolar lavage is performed. | Drug | B |
| placeboParticipants inhale placebo twice daily via discus. Before and after this therapy, a bronchoalveolar lavage is performed. | Drug | C |
Primary outcome
The number and the CCR7 expression of DCs in bronchoalveolar lavage fluid before and after therapy with fluticasone or fluticasone/salmeterol, as compared to placebo.
Time frame: 2 time points (A and B). Time point A: day 0 (directly before the inhalation therapy). Time point B: day 29 (directly after the inhalation therapy).
1 secondary outcome
The expression of other surface molecules on DCs in bronchoalveolar lavage fluid before and after therapy with fluticasone or fluticasone/salmeterol, as compared to placebo.
Time frame: 2 time points (A and B). Time point A: day 0 (directly before the inhalation therapy). Time point B: day 29 (directly after the inhalation therapy).
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 13 Jan 2010.
- 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.
- Derived from this study: PubMed 24168756Lommatzsch M, Kraeft U, Troebs L, Garbe K, Bier A, Stoll P, Klammt S, Kuepper M, Bratke K, Virchow JC. Fluticasone impact on airway dendritic cells in smokers: a randomized controlled trial. Respir Res. 2013 Oct 29;14(1):114. doi: 10.1186/1465-9921-14-114.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing fluticasone and fluticasone/salmeterol in people with Smoke-related Lung Diseases and Chronic Obstructive Pulmonary Disease, 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 3 inclusion and 5 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 13 Jan 2010. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The number and the CCR7 expression of DCs in bronchoalveolar lavage fluid before and after therapy with fluticasone or fluticasone/salmeterol, as compared to placebo. (time frame: 2 time points (A and B). Time point A: day 0 (directly before the inhalation therapy). Time point B: day 29 (directly after the inhalation therapy).). 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 NCT00908362, which also lists 2 linked publications.
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 13 Jan 2010.