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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-001589-13 | EudraCT Number |
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| Name | Class |
|---|---|
| The Intensive Care Society United Kingdom | UNKNOWN |
| Northern Ireland Clinical Trials Unit | OTHER |
| Queen's University, Belfast | OTHER |
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This is a double-blind, placebo-controled, randomized trial to investigate if aspirin pre-treatment has anti-inflammatory effects in a model of acute lung injury induced by inhaled endotoxin (LPS) in healthy human volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aspirin 75mg | Active Comparator | Aspirin 75mg once daily for 7 days. Administered by mouth. |
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| Aspirin 1200mg | Active Comparator | Asprin 600mg twice daily for 7 days. Administered by mouth. |
|
| Lactose powder | Placebo Comparator | Placebo for 7 days. Administered by mouth. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aspirin 75mg | Drug | Subjects randomised to aspirin 75mg will receive 1 container containing aspirin 75mg and 1 container containing placebo for the morning and 2 containers containing placebo for the evening. Subjects will take one capsule from each container in the morning and one capsule from each container in the evening. |
| Measure | Description | Time Frame |
|---|---|---|
| Bronchoalveolar lavage IL-8 concentration | 6 hrs after LPS inhalation |
| Measure | Description | Time Frame |
|---|---|---|
| Alveolar inflammatory response biomarkers | 6 hrs after LPS inhalation | |
| Plasma inflammatory response biomarkers | 6 and 24 hrs after LPS inhalation | |
| Alveolar epithelial and endothelial function and injury biomarkers |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Danny McAuley | Queens University, Belfast | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Belfast Health and Social Care Trust | Belfast | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28082531 | Derived | Hamid U, Krasnodembskaya A, Fitzgerald M, Shyamsundar M, Kissenpfennig A, Scott C, Lefrancais E, Looney MR, Verghis R, Scott J, Simpson AJ, McNamee J, McAuley DF, O'Kane CM. Aspirin reduces lipopolysaccharide-induced pulmonary inflammation in human models of ARDS. Thorax. 2017 Nov;72(11):971-980. doi: 10.1136/thoraxjnl-2016-208571. Epub 2017 Jan 12. | |
| 26494395 |
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| ID | Term |
|---|---|
| D055371 | Acute Lung Injury |
| D012128 | Respiratory Distress Syndrome |
| ID | Term |
|---|---|
| D055370 | Lung Injury |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
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| ID | Term |
|---|---|
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
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| Lactose powder | Drug | Subjects randomised to placebo will receive 4 containers of placebo, 2 containers containing placebo for the morning and 2 containers containing placebo for the evening. Subjects will take one capsule from each container in the morning and one capsule from each container in the evening. |
|
| Aspirin 1200mg | Drug | Subjects randomised to aspirin 600mg 12 hourly will receive 2 containers of aspirin 300mg each for the morning and 2 containers of aspirin 300mg each for the evening. Subjects will take one capsule from each container in the morning and one capsule from each container in the evening. |
|
| 6 hrs after LPS inhalation |
| Lipid inflammatory mediators | 6 and 24 hrs after LPS inhalation |
| Toner P, McAuley DF, Shyamsundar M. Aspirin as a potential treatment in sepsis or acute respiratory distress syndrome. Crit Care. 2015 Oct 23;19:374. doi: 10.1186/s13054-015-1091-6. |
| 25486575 | Derived | Curley GF, McAuley DF. Stem cells for respiratory failure. Curr Opin Crit Care. 2015 Feb;21(1):42-9. doi: 10.1097/MCC.0000000000000171. |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |