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

NCT05536375 | Completed

• 1 other identifier: 2022/2149
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• No of participant with IL-11 detected in EBC and/or blood

  A pilot study to optimize the feasibility of detection of IL-11 in EBC and blood, and other interleukins in blood of healthy volunteers.

  2 years

Study Arms (1)

Healthy volunteers

OTHER

Other: Exhaled breath condensate collection and blood draw

Interventions

Exhaled breath condensate collection and blood draw OTHER

Venepuncture- 10mls of blood to be collected and Exhaled breath condensate (EBC) collection method- this involved breathing in and out through a disposable device (akin to breathing onto cold glass to produce condensate) with an external cooler device. The R Tube starter kit is a complete disposable EBC collection kit and It has been used in many research clinical investigations.

Healthy volunteers

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 21-65 years old with no pre-existing medical condition
• Not on any long term medication
• Non smoker

You may not qualify if:

• Previous myocardial infarction (MI), inclusive of ST-elevation MI (STEMI) and non-ST-elevation MI (NSTEMI)
• Known coronary artery disease or known flow limiting CAD (\>75% stenosis)
• Prior cardiac surgery (including but not limited to PCI, CABG, ICD/PPM implant etc)
• BMI\>35
• Alcohol intake \>10 units per week
• Known definite diabetes mellitus or on treatment for diabetes mellitus
• Asthma or chronic obstructive pulmonary disease
• Subject who is pregnant.
• Smoker (including ex-smoker and social smoker)
• Chronic infective disease, including tuberculosis, hepatitis B and C; and HIV
• Prior history of cancer (excludes pre-cancerous lesions)
• Expected life expectancy less than 1 year
• Known documented peripheral arterial disease
• Known autoimmune disease or genetic disease
• Known endocrine disease on treatment

Sponsors & Collaborators

• National Heart Centre Singapore: lead

Study Sites (1)

National Heart Centre Singapore

Singapore, Singapore, 169609, Singapore

Location

Related Publications (7)

• Serum interleukin-10 and interleukin-11 in patients in acute pancreatitis

  BACKGROUND

• Ng B, Dong J, D'Agostino G, Viswanathan S, Widjaja AA, Lim WW, Ko NSJ, Tan J, Chothani SP, Huang B, Xie C, Pua CJ, Chacko AM, Guimaraes-Camboa N, Evans SM, Byrne AJ, Maher TM, Liang J, Jiang D, Noble PW, Schafer S, Cook SA. Interleukin-11 is a therapeutic target in idiopathic pulmonary fibrosis. Sci Transl Med. 2019 Sep 25;11(511):eaaw1237. doi: 10.1126/scitranslmed.aaw1237.

  PMID: 31554736 BACKGROUND

• Ng B, Cook SA, Schafer S. Interleukin-11 signaling underlies fibrosis, parenchymal dysfunction, and chronic inflammation of the airway. Exp Mol Med. 2020 Dec;52(12):1871-1878. doi: 10.1038/s12276-020-00531-5. Epub 2020 Dec 1.

  PMID: 33262481 BACKGROUND

• Ng B, Dong J, Viswanathan S, Widjaja AA, Paleja BS, Adami E, Ko NSJ, Wang M, Lim S, Tan J, Chothani SP, Albani S, Schafer S, Cook SA. Fibroblast-specific IL11 signaling drives chronic inflammation in murine fibrotic lung disease. FASEB J. 2020 Sep;34(9):11802-11815. doi: 10.1096/fj.202001045RR. Epub 2020 Jul 12.

  PMID: 32656894 BACKGROUND

• Role of interleukins in the pathogenesis of pulmonary fibrosis

  BACKGROUND

• Wu J, Chen J, Lv X, Yang Q, Yao S, Zhang D, Chen J. Clinical value of serum and exhaled breath condensate inflammatory factor IL-11 levels in non-small cell lung cancer: Clinical value of IL-11 in non-small cell lung cancer. Int J Biol Markers. 2021 Jun;36(2):64-76. doi: 10.1177/17246008211023515. Epub 2021 Jun 18.

  PMID: 34142593 BACKGROUND

• She YX, Yu QY, Tang XX. Role of interleukins in the pathogenesis of pulmonary fibrosis. Cell Death Discov. 2021 Mar 15;7(1):52. doi: 10.1038/s41420-021-00437-9.

  PMID: 33723241 BACKGROUND

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Chua Yang Chong, Principal Investigator

  National Heart Centre Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Participant will be assigned a research ID which will be used for sample and data analysis.
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 25 healthy adult volunteers who are:- 1. Aged 21-65 years old with no pre-existing medical condition 2. Not on any long term medication 3. Non smoker

Study Record Dates

• First Submitted: September 7, 2022
• First Posted: September 10, 2022
• Study Start: September 20, 2022
• Primary Completion: February 21, 2023
• Study Completion: February 21, 2023
• Last Updated: April 20, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)