The intended indication for the product under development is that of acute lung injury. MedDRA version: 14.1 Level: PT Classification code 10069351 Term: Acute lung injury System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Product Name: Aspirin 75mg
Pharmaceutical Form: Capsule
INN or Proposed INN: Aspirin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 75mg-
INN or Proposed INN: Aspi
Sponsors
Belfast Health and Social Care Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria: 1. Healthy non-smoking subjects Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: Exclusion criteria: 1. Age < 18 years 2. Pregnancy or breast feeding or woman of childbearing potential not using adequate contraception. 3. Participation in a clinical trial of an investigational medicinal product within 30 days 4. Consent declined 5. Aspirin or non steroidal anti-inflammatory (NSAID) use in the past 4 weeks 6. History of asthma 7. Known aspirin or NSAID hypersensitivity 8. History of peptic ulcer disease 9. Platelet count < 150 x 106/ml 10. Aspirin resistance Aspirin resistance is uncommon and therefore it is not anticipated that it will have a significant impact on the study. However subjects who do not show a change in measures of aspirin responsiveness following aspirin will be excluded. Aspirin responsiveness will be measured by Optical Platelet Aggregometry
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main aim of this study is to look at the effects of a drug called aspirin at reducing inflammation in the lungs compared to a placebo(dummy) drug in healthy volunteers after inhalation of a substance which causes a low level of inflammation in the lungs without any adverse effects.;Secondary Objective: The secondary aims of this study are to examine other important mechanisms by which aspirin may work in reducing lung inflammation and injury. If a beneficial effect was confirmed, a phase 2/3 clinical trial to determine effectiveness and safety of aspirin in patients with ALI/ARDS would be required.;Primary end point(s): The primary outcome for this study is BAL IL-8 concentration at 6 hours following LPS administration. This endpoint was chosen as dysregulated alveolar inflammation is important in the development of lung injury and aspirin has a range of anti-inflammatory effects. Specifically IL-8 is a potent neutrophil chemoattractant present in the alveolar space early in course of ALI , treatment with anti-IL-8 monoclonal antibody in experimental animal models of lung injury has been shown to attenuate injury and increased plasma IL-8 is associated with mortality in ALI suggesting that it is important in the pathophysiology of lung injury. ;Timepoint(s) of evaluation of this end point: BAL IL-8 concentration will be measured at 6 hours following LPS administration, following 7 days treatment with aspirin or placebo. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary outcomes are to investigate if pre-treatment with aspirin will modulate: 1. Alveolar inflammatory response 2. Plasma inflammatory response 3. Intracellular signalling activity in the alveolar space 4. Indices of alveolar epithelial and endothelial function and injury 5. Lipid inflammatory mediators ;Timepoint(s) of evaluation of this end point: These secondary endpoints will be measured in BAL at 6 hours and in plasma at 24 hours following LPS administration, following 7 days treatment with aspirin or placebo. | — |
Countries
United Kingdom
Outcome results
None listed