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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator | Inhalation of Fluticasone (via discus) twice daily for 28 days |
|
| B | Active Comparator | Inhalation of Fluticasone and Salmeterol (via discus) twice daily for 28 days |
|
| C | Placebo Comparator | Inhalation of Placebo (via discus) twice daily for 28 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fluticasone | Drug | Participants inhale fluticasone (250 µg) via discus. Before and after this therapy, a bronchoalveolar lavage is performed. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dep. of Pneumology, University of Rostock | Rostock | Mecklenburg-Vorpommern | 18057 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18203971 | Background | 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. | |
| 24168756 | Derived | Lommatzsch 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. |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D000068298 | Fluticasone |
| D000068297 | Fluticasone-Salmeterol Drug Combination |
| ID | Term |
|---|---|
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 |
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| fluticasone/salmeterol | Drug | Participants inhale fluticasone/salmeterol (250/50µg) via discus. Before and after this therapy, a bronchoalveolar lavage is performed. |
|
| placebo | Drug | Participants inhale placebo twice daily via discus. Before and after this therapy, a bronchoalveolar lavage is performed. |
|
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D000068299 | Salmeterol Xinafoate |
| D000420 | Albuterol |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |