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Investigating potential treatments for human lung injury in healthy volunteers

Inhaled lipopolysaccharide challenge as a human model to investigate potential therapies in Acute Respiratory Distress Syndrome

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN16086655
Enrollment
30
Registered
2024-04-26
Start date
2024-10-01
Completion date
Unknown
Last updated
2025-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Distress Syndrome (ARDS) Respiratory

Interventions

Participants will be randomised to intervention or comparator by computer programme. The intervention will be Baricitinib (Olumiant) 4 mg orally, once daily for 3 days. Comparator is no interventi

Sponsors

Belfast Health and Social Care Trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Healthy non-smoking adults aged 18-45 years old

Exclusion criteria

Exclusion criteria: 1. Age 45 years 3. BMI >30 kg/m² 4. On concomitant medications including over-the-counter medications excluding hormonal contraception and paracetamol 5. Previous adverse reactions to LPS, lignocaine or sedative agents 6. Pregnant or breast-feeding 7. Participation in a clinical trial of an investigational medicinal product within 30 days 8. Consent declined 9. History of asthma or other respiratory conditions 10. Smoking or e-cigarette use 11. Marijuana use or other inhaled products (with or without nicotine) in the last 3 months 12. Alcohol abuse, as defined by the Alcohol Use Disorders Identification Test (AUDIT) 13. Subjects with history of prior conventional cigarette (> 100 cigarettes lifetime and smoking within 6 months) or electronic cigarette use. 14. Live vaccine with in preceeding 4 weeks 15. Abnormal blood count, renal function or liver function tests identified at screening 16. History of shingles 17. History of Hepatitis B/C 18. Allergy to Baricitinib

Design outcomes

Primary

MeasureTime frame
Broncho-alveolar lavage neutrophil count during bronchoscopy at day 4

Secondary

MeasureTime frame
Broncho-alveolar lavage fluid/Plasma/Urine: cytokines including but not limited to Il-6, IL-10, IL-18, CXCL8, IL-1b, markers of epithelial and endothelial injury including but not limited to RAGE, SP-D, Ang2, single-cell RNA sequencing, plasma differential white cell count, BAL differential white cell count, plasma C-reactive protein

Countries

Northern Ireland, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026