ASpirin as a Treatment for ARDS (STAR): a Phase 2 Randomised Control Trial

NCT02326350 | Terminated Phase 2 DMC

• 1 other identifier: 14043DMcA-AS
• Study Type: interventional
• Target: 49
• Locations: 0 countries
• Sites: N/A

Brief Summary

Acute Respiratory Distress Syndrome (ARDS) causes the lungs to fail due to the collection of fluid in the lungs (pulmonary oedema). ARDS is common in severely ill patients in Intensive Care Units and is associated with a high mortality and a high morbidity in those who survive. There is a large economic burden with direct healthcare costs, but also indirectly due to the impact on the carer and patient through their inability to return to full time employment. There is little evidence for effective drug (pharmacological) treatment for ARDS. Blood cells called platelets have increasingly been recognized to play a key role in the development of ARDS. There is increasing information that aspirin, a drug which is widely used to treat heart disease, might be important in treating ARDS. We plan to test if aspirin will help in the treatment of ARDS. To do this we will divide patients suffering from ARDS into two groups, one of which will get aspirin and the other a harmless dummy (or placebo) tablet who will then be followed up to determine if lung function improves. If effective this may lead to further research to determine if aspirin is effective in patients with ARDS. This project will also provide new information about mechanisms in the development of ARDS leading, potentially, to other new treatments.

Conditions

Acute Respiratory Distress Syndrome

Keywords

Acute Respiratory Distress syndrome; Aspirin

Outcome Measures

Primary Outcomes (1)

• Oxygenation index (OI)

  OI is a physiological index of the severity of ARDS and measures both impaired oxygenation and the amount of mechanical ventilation delivered.

  Day 7

Secondary Outcomes (5)

• Oxygenation index

  Days 4 and 14

• Sequential organ failure assessment (SOFA) score

  Days 4, 7 and 14

• Respiratory compliance (Crs)

  Days 4, 7 and 14

• Partial pressure of arterial oxygen to the fraction of inspired oxygen ratio (P/F ratio)

  Days 4, 7 and 14

• Safety and tolerability as assessed by the occurrence of serious adverse events and suspected unexpected serious adverse reactions

  Up to 28 days after completion of study drug

Study Arms (2)

Aspirin 75mg

EXPERIMENTAL

Aspirin 75mg enterally once daily for a maximum of 14 days

Drug: Aspirin 75mg

Placebo

PLACEBO COMPARATOR

Lactose powder placebo enterally once daily for a maximum of 14 days

Drug: Lactose powder

Interventions

Aspirin 75mg DRUG

Active treatment

Aspirin 75mg

Lactose powder DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients receiving invasive mechanical ventilation.
• ARDS as defined by the Berlin definition.
• Onset within 1 week of identified insult.
• Within the same 24 hours
• Hypoxic respiratory failure (PaO2/ FiO2 ratio ≤ 40kPa on PEEP ≥ 5 cmH20),
• Bilateral infiltrates on chest X-ray consistent with pulmonary oedema not explained by another pulmonary pathology,
• No evidence of heart failure or volume overload

You may not qualify if:

• More than 72 hours from the onset of ARDS.
• Age \< 16 years.
• Patient is known to be pregnant.
• Participation in a clinical trial of an investigational medicinal product within 30 days.
• Current treatment with aspirin or within the past 4 weeks.
• Platelet count \< 50 x 109/l.
• Haemophilia or other haemorrhagic disorder or concurrent therapeutic anticoagulant therapy.
• History of aspirin sensitive asthma or nasal polyps associated with asthma.
• Active or history of recurrent peptic ulcer and/ or gastric/ intestinal haemorrhage or other kinds of bleeding such as cerebrovascular haemorrhage.
• Traumatic brain injury.
• Active gout.
• Currently receiving methotrexate.
• Severe chronic liver disease with Child-Pugh score \> 12.
• Known hypersensitivity or previous adverse reaction to salicylic acid compounds or prostaglandin synthetase inhibitors.
• Physician decision that aspirin is required for proven indication.

Sponsors & Collaborators

• Belfast Health and Social Care Trust: lead
• Queen's University, Belfast: collaborator
• Northern Ireland Clinical Trials Unit: collaborator

Related Publications (2)

• Toner P, Boyle AJ, McNamee JJ, Callaghan K, Nutt C, Johnston P, Trinder J, McFarland M, Verghis R, McAuley DF, O'Kane CM. Aspirin as a Treatment for ARDS: A Randomized, Placebo-Controlled Clinical Trial. Chest. 2022 May;161(5):1275-1284. doi: 10.1016/j.chest.2021.11.006. Epub 2021 Nov 14.

  PMID: 34785236 DERIVED

• 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.

  PMID: 26494395 DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Danny F McAuley, Professor

  Belfast Health and Social Care Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and consultant of Intensive Care Medicine

Study Record Dates

• First Submitted: December 16, 2014
• First Posted: December 29, 2014
• Study Start: February 6, 2015
• Primary Completion: November 23, 2018
• Study Completion: November 23, 2018
• Last Updated: March 13, 2019

Record last verified: 2019-03