The main aim of this study is to look at the effects of a drug called aspirin at reducing inflammation in the lungs

• Conditions: The intended indication for the product under development is that of acute lung injury.; MedDRA version: 14.1Level: PTClassification code 10069351Term: Acute lung injurySystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2012-001589-13-GB
• Lead Sponsor: Belfast Health and Social Care Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05-18
• Last Update Posted: 24 July 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified