Trial | NCT01659307  Report issue

Official Title

The Effect of Aspirin on REducing iNflammation in Human in Vivo Model of Acute Lung Injury

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    33
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.
Study Started
Sep 30
2012
Primary Completion
Sep 09
2022
Study Completion
Sep 09
2022
Last Update
Sep 13
2022

Drug Aspirin 75mg

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.

Drug Lactose powder

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.

Drug Aspirin 1200mg

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.

Aspirin 75mg Active Comparator

Aspirin 75mg once daily for 7 days. Administered by mouth.

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.

Criteria 

Inclusion Criteria:

Healthy subjects

Exclusion Criteria:

Age < 18 years
Pregnancy or breast feeding or woman of childbearing potential not using
adequate contraception.
Participation in a clinical trial of an investigational medicinal product within 30 days
Consent declined Aspirin or non steroidal anti-inflammatory (NSAID) use in the past 4 weeks
History of asthma
Known aspirin or NSAID hypersensitivity
History of peptic ulcer disease
Platelet count < 150 x 106/ml
Aspirin resistance
No Results Posted