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A Pilot Feasibility Study of Detection of IL-11 and Other Cytokines in the Exhaled Breath Condensate (EBC) and Blood of Healthy Volunteers

Sponsored by National Heart Centre Singapore

About this trial

Last updated 2 years ago

Study ID

2022/2149

Status

Recruiting

Type

Interventional

Phase

N/A

Placebo

No

Accepting

18-75 Years
21 to 65 Years
All
All

Trial Timing

Ended a year ago

What is this trial about?

IL-11 is a receptor previously proven to be highly expressed in human lungs with idiopathic lung fibrosis, and in animal model, IL-11 receptor neutralizing antibody has been shown to prevent the process of fibrosis in bleomycin-induced lung fibrosis in rats. Separately, investigators know the expression of IL-11 can be detected in human by measuring its expression in the exhaled breath condensate (EBC) and serum. With the sera obtained, investigators will examine a whole range of other interleukins which had been implicated in mammalian lung fibrosis. Investigators aim to measure IL-11 in a pilot of human volunteers (healthy). This is important to subsequently see if IL-11 expression is increased in patients with a range of fibrotic diseases, with the potential to be used as diagnostic tool as well and to select patients who may benefit from IL-11 neutralizing antibody to delay/ cure their lung fibrosis including patients with idiopathic pulmonary fibrosis (IPF), drug/ radiation induced fibrosis and possibly even lung fibrosis as a chronic sequelae of COVID infection. IL-11 also has been shown to be highly relevant in cardiac patients- including chronic heart failure patients. Having reference ranges for IL-11 in the blood and EBC of healthy human volunteers will also be useful in future drug trials for IL-11 antibodies for future cardiac studies.

What are the participation requirements?

Yes

Inclusion Criteria

1. Aged 21-65 years old with no pre-existing medical condition

2. Not on any long term medication

3. Non smoker

No

Exclusion Criteria

1. Previous myocardial infarction (MI), inclusive of ST-elevation MI (STEMI) and non-ST-elevation MI (NSTEMI)

2. Known coronary artery disease or known flow limiting CAD (>75% stenosis)

3. Prior cardiac surgery (including but not limited to PCI, CABG, ICD/PPM implant etc)

4. BMI>35

5. Alcohol intake >10 units per week

6. Known definite diabetes mellitus or on treatment for diabetes mellitus

7. Asthma or chronic obstructive pulmonary disease

8. Subject who is pregnant.

9. Smoker (including ex-smoker and social smoker)

10. Chronic infective disease, including tuberculosis, hepatitis B and C; and HIV

11. Prior history of cancer (excludes pre-cancerous lesions)

12. Expected life expectancy less than 1 year

13. Known documented peripheral arterial disease

14. Known autoimmune disease or genetic disease

15. Known endocrine disease on treatment

16. Psychiatric illness

17. Previous stroke

18. Inability to comply with study protocol

Locations

Location

Status

Recruiting