Acute Lung InjuryPhase 2ARENANCT01659307
The Effect of Aspirin on REducing iNflammation in Human in Vivo Model of Acute Lung Injury
A Phase 2 study testing Aspirin 75mg, Lactose powder and Aspirin 1200mg in people with Acute Lung Injury, run by Belfast Health and Social Care Trust at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Lung Injury
- What is being tested?
- Aspirin 75mg, Lactose powder and Aspirin 1200mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2012to 9 Sep 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy subjects
Who cannot join
- 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
Show all 10Show fewer
- Known aspirin or NSAID hypersensitivity
- History of peptic ulcer disease
- Platelet count < 150 x 106/ml
- Aspirin resistance
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Acute Lung Injury
- Being tested
- Aspirin 75mg, Lactose powder, Aspirin 1200mg
- Keywords
- Acute Lung Injury, Acute Respiratory Distress Syndrome, Aspirin
- Medical subject headings
- Acute Lung Injury, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aspirin 75mgDrug
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.
Lactose powderDrug
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 1200mgDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Aspirin 75mg | Active comparator | Aspirin 75mg once daily for 7 days. Administered by mouth. Receives: Drug: Aspirin 75mg |
| Aspirin 1200mg | Active comparator | Asprin 600mg twice daily for 7 days. Administered by mouth. Receives: Drug: Aspirin 1200mg |
| Lactose powder | Placebo comparator | Placebo for 7 days. Administered by mouth. Receives: Drug: Lactose powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bronchoalveolar lavage IL-8 concentration
Measured: 6 hrs after LPS inhalation
Secondary outcomes (4)
Alveolar inflammatory response biomarkers
Measured: 6 hrs after LPS inhalation
Plasma inflammatory response biomarkers
Measured: 6 and 24 hrs after LPS inhalation
Alveolar epithelial and endothelial function and injury biomarkers
Measured: 6 hrs after LPS inhalation
Lipid inflammatory mediators
Measured: 6 and 24 hrs after LPS inhalation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2012 (estimated)
- Study startSep 2012
- Primary completion9 Sep 2022
- Study completion9 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute Lung InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Belfast Health and Social Care Trust
- Sponsor type
- University, hospital or other
- Collaborators
- The Intensive Care Society United Kingdom, Northern Ireland Clinical Trials Unit, Queen's University, Belfast
- Responsible party
- Principal investigator, Professor Danny McAuley, Belfast Health and Social Care Trust
- Investigators
- Danny McAuley, Principal investigator, Queens University, Belfast
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01659307
- Sponsor's protocol ID
- 11127DMcA-AS
- Other IDs
- 2012-001589-13
- Acronym
- ARENA
- Status last verified
- Sep 2022
- First submitted
- 4 Aug 2012
- Last updated
- 13 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 28082531Toner 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.
PubMed 26494395Curley GF, McAuley DF. Stem cells for respiratory failure. Curr Opin Crit Care. 2015 Feb;21(1):42-9. doi: 10.1097/MCC.0000000000000171.
PubMed 25486575
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Aspirin on REducing iNflammation in Human in Vivo Model of Acute Lung Injury
- ClinicalTrials.gov ID
- NCT01659307
- Acronym / sponsor ID
- ARENA / 11127DMcA-AS
- Conditions
- Acute Lung Injury
- Keywords
- Acute Lung Injury, Acute Respiratory Distress Syndrome, Aspirin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Belfast Health and Social Care TrustUniversity, hospital or other
- Collaborators
- The Intensive Care Society United Kingdom, Northern Ireland Clinical Trials Unit, Queen's University, Belfast
- Study start
- Sep 2012
- Primary completion
- 9 Sep 2022 (actual)
- Study completion
- 9 Sep 2022 (actual)
- First posted
- 7 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aspirin 75mg | Active comparator | Drug: Aspirin 75mgAspirin 75mg once daily for 7 days. Administered by mouth. |
| Aspirin 1200mg | Active comparator | Drug: Aspirin 1200mgAsprin 600mg twice daily for 7 days. Administered by mouth. |
| Lactose powder | Placebo comparator | Drug: Lactose powderPlacebo for 7 days. Administered by mouth. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy subjects
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aspirin 75mgSubjects 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 | Aspirin 75mg |
| Lactose powderSubjects 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 | Lactose powder |
| Aspirin 1200mgSubjects 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. | Drug | Aspirin 1200mg |
Primary outcome
Bronchoalveolar lavage IL-8 concentration
Time frame: 6 hrs after LPS inhalation
4 secondary outcomes
Alveolar inflammatory response biomarkers
Time frame: 6 hrs after LPS inhalation
Plasma inflammatory response biomarkers
Time frame: 6 and 24 hrs after LPS inhalation
Alveolar epithelial and endothelial function and injury biomarkers
Time frame: 6 hrs after LPS inhalation
Lipid inflammatory mediators
Time frame: 6 and 24 hrs after LPS inhalation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2022.
- Derived from this study: PubMed 28082531Hamid 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.
- Derived from this study: PubMed 26494395Toner 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.
- Derived from this study: PubMed 25486575Curley GF, McAuley DF. Stem cells for respiratory failure. Curr Opin Crit Care. 2015 Feb;21(1):42-9. doi: 10.1097/MCC.0000000000000171.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Danny McAuley principal investigator
Queens University, Belfast
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Aspirin 75mg, Lactose powder and Aspirin 1200mg in people with Acute Lung Injury, run by Belfast Health and Social Care Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bronchoalveolar lavage IL-8 concentration (time frame: 6 hrs after LPS inhalation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01659307, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2022.