HealthyNCT05536375
A Pilot Feasibility Study of Detection of IL-11 and Other Cytokines in the Exhaled Breath Condensate (EBC) and Blood of Healthy Volunteers
A study testing Exhaled breath condensate collection and blood draw in people with Healthy, run by National Heart Centre Singapore at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Exhaled breath condensate collection and blood draw
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSingapore
- Study dates
- 20 Sep 2022to 21 Feb 2023
- Phase
- Interventional
- 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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 21-65 years old with no pre-existing medical condition
- Not on any long term medication
- Non smoker
Who cannot join
- 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
Show all 18Show fewer
- 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
- Psychiatric illness
- Previous stroke
- Inability to comply with study protocol
Trial locations and contacts
1 site in 1 country.
Singapore1 site
National Heart Centre Singapore
Singapore, Singapore, 169609
About this study
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.
Read the detailed description
IL-11 has been proven to be highly expressed in lungs of patients with idiopathic pulmonary fibrosis (IPF), a type of interstitial lung disease (ILD). An IL-11 neutralizing antibody has been shown to diminish lung inflammation and fibrosis in bleomycin induced lung fibrosis in mice model. In this study, IL-11 has also been shown to be expressed in samples of human lungs with IPF. The mechanism had been shown to be linked to reduction of fibroblast proliferation and activity.
The identification of individuals with different sub-types of lung fibrosis can be based on symptoms, lung function tests, radiology or even lung biopsies. However, all these methods are rather subjective and sometimes invasive but yet inconclusive. So to identify individual patients whom IL-11 may play a role in their disease processes, investigators propose to use IL-11 in EBC as a biomarker to identify these patients.
The design of this pilot study is; prospective, single arm, non-interventional study involving invasive investigations
- Procedures/ investigations
- Blood taking (venepuncture)
- 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 that is FDA approved in USA. It has been used in many research clinical investigations. Investigators prefer completely disposable kits (not just mouthpiece).
Laboratory method in detection and quantification of IL-11 (ELISA)- Investigators will use the Human IL-11 Quantikine ELISA kit (#D1100, R\&D Systems) to measure IL-11 concentrations in serum/ plasma, and EBC. This immunoassay has been used by Prof Cook's team for accurate quantification of IL-11 concentrations within the assay ranges of 31.2 - 2,000 pg/mL in studies, and possess a similar a detection range to that of another IL-11 ELISA kit used in a prior publication which quantified IL-11 concentrations in the serum and EBC. Each ELISA kit allows for simultaneous detection in up to 96 samples (including duplicates and standards). The assay employs the quantitative sandwich ELISA technique. Investigators may also use similar technique to examine the whole range of other interleukins which involved in lung fibrosis.
The use of EBC to detect IL-11 has been previously shown to be feasible and detectable in healthy volunteers. In that series, it was demonstrated that IL-11 levels were significantly increased in patients with NSCLC. Investigators first need to reproduce the feasibility of detection of IL-11 in EBC of healthy volunteers and use this as a reference range for levels of IL-11 in EBC of patients with fibrosis. IL-11 has previously been shown to be detectable in serum of human patients with pancreatitis by ELISA kits too. If this is the case, investigators can propose to use IL-11 as a screening tool, to identify patients who may benefit from IL-11 neutralizing antibody when this is available in humans.
Other interleukins which have been shown to contribute to lung fibrosis are IL-1B and IL-5, in rat animal models, by promoting inflammation. IL-9, IL-10, and IL-17 on the other hand are protective in lung fibrosis. IL-12 inhibits collagen synthesis. IL-2, IL-4, IL-6, IL-13, IL-18 and IL-37 have also been shown to contribute to lung fibrosis through cell proliferation and fibroblasts activation, rather than direct inflammation. More importantly, IL-2, IL-6, IL-8, IL-10, and IL-12 have been shown to be increased in sera of patients with IPF compared to healthy volunteers.
- Conditions
- Healthy
- Being tested
- Exhaled breath condensate collection and blood draw
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exhaled breath condensate collection and blood drawOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Other | Not described Receives: Other: Exhaled breath condensate collection and blood draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2022
- Study start20 Sep 2022
- Primary completion21 Feb 2023
- Study completion21 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Heart Centre Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chua Yang Chong, Principal Investigator, Principal investigator, National Heart Centre Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05536375
- Sponsor's protocol ID
- 2022/2149
- Status last verified
- Feb 2025
- First submitted
- 7 Sep 2022
- Last updated
- 20 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participants will be assigned a research ID that only research coordinator and team knows
Publications
Serum interleukin-10 and interleukin-11 in patients in acute pancreatitis
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.
PubMed 31554736Ng 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.
PubMed 33262481Ng 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.
PubMed 32656894Role of interleukins in the pathogenesis of pulmonary fibrosis
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.
PubMed 34142593She 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.
PubMed 33723241
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Feasibility Study of Detection of IL-11 and Other Cytokines in the Exhaled Breath Condensate (EBC) and Blood of Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05536375
- Acronym / sponsor ID
- 2022/2149
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- National Heart Centre SingaporeUniversity, hospital or other
- Study start
- 20 Sep 2022 (actual)
- Primary completion
- 21 Feb 2023 (actual)
- Study completion
- 21 Feb 2023 (actual)
- First posted
- 10 Sep 2022 (actual)
- 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.
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.
Detailed description
IL-11 has been proven to be highly expressed in lungs of patients with idiopathic pulmonary fibrosis (IPF), a type of interstitial lung disease (ILD). An IL-11 neutralizing antibody has been shown to diminish lung inflammation and fibrosis in bleomycin induced lung fibrosis in mice model. In this study, IL-11 has also been shown to be expressed in samples of human lungs with IPF. The mechanism had been shown to be linked to reduction of fibroblast proliferation and activity.
The identification of individuals with different sub-types of lung fibrosis can be based on symptoms, lung function tests, radiology or even lung biopsies. However, all these methods are rather subjective and sometimes invasive but yet inconclusive. So to identify individual patients whom IL-11 may play a role in their disease processes, investigators propose to use IL-11 in EBC as a biomarker to identify these patients.
The design of this pilot study is; prospective, single arm, non-interventional study involving invasive investigations
- Procedures/ investigations
- Blood taking (venepuncture)
- 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 that is FDA approved in USA. It has been used in many research clinical investigations. Investigators prefer completely disposable kits (not just mouthpiece).
Laboratory method in detection and quantification of IL-11 (ELISA)- Investigators will use the Human IL-11 Quantikine ELISA kit (#D1100, R\&D Systems) to measure IL-11 concentrations in serum/ plasma, and EBC. This immunoassay has been used by Prof Cook's team for accurate quantification of IL-11 concentrations within the assay ranges of 31.2 - 2,000 pg/mL in studies, and possess a similar a detection range to that of another IL-11 ELISA kit used in a prior publication which quantified IL-11 concentrations in the serum and EBC. Each ELISA kit allows for simultaneous detection in up to 96 samples (including duplicates and standards). The assay employs the quantitative sandwich ELISA technique. Investigators may also use similar technique to examine the whole range of other interleukins which involved in lung fibrosis.
The use of EBC to detect IL-11 has been previously shown to be feasible and detectable in healthy volunteers. In that series, it was demonstrated that IL-11 levels were significantly increased in patients with NSCLC. Investigators first need to reproduce the feasibility of detection of IL-11 in EBC of healthy volunteers and use this as a reference range for levels of IL-11 in EBC of patients with fibrosis. IL-11 has previously been shown to be detectable in serum of human patients with pancreatitis by ELISA kits too. If this is the case, investigators can propose to use IL-11 as a screening tool, to identify patients who may benefit from IL-11 neutralizing antibody when this is available in humans.
Other interleukins which have been shown to contribute to lung fibrosis are IL-1B and IL-5, in rat animal models, by promoting inflammation. IL-9, IL-10, and IL-17 on the other hand are protective in lung fibrosis. IL-12 inhibits collagen synthesis. IL-2, IL-4, IL-6, IL-13, IL-18 and IL-37 have also been shown to contribute to lung fibrosis through cell proliferation and fibroblasts activation, rather than direct inflammation. More importantly, IL-2, IL-6, IL-8, IL-10, and IL-12 have been shown to be increased in sera of patients with IPF compared to healthy volunteers.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | Other | Other: Exhaled breath condensate collection and blood draw |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 21-65 years old with no pre-existing medical condition
- Not on any long term medication
- Non smoker
Key exclusion criteria (18 listed)
- 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
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 |
|---|---|---|
| Exhaled breath condensate collection and blood drawVenepuncture- 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. | Other | Healthy volunteers |
Primary outcome
No of participant with IL-11 detected in EBC and/or blood
Time frame: 2 years
A pilot study to optimize the feasibility of detection of IL-11 in EBC and blood, and other interleukins in blood of healthy volunteers.
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 20 Apr 2025.
- BackgroundSerum interleukin-10 and interleukin-11 in patients in acute pancreatitis
- Background: PubMed 31554736Ng 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.
- Background: PubMed 33262481Ng 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.
- Background: PubMed 32656894Ng 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.
- BackgroundRole of interleukins in the pathogenesis of pulmonary fibrosis
- Background: PubMed 34142593Wu 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.
- Background: PubMed 33723241She 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.
- Individual participant dataSharing planned: No. Participants will be assigned a research ID that only research coordinator and team knows
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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.
Chua Yang Chong, Principal Investigator principal investigator
National Heart Centre Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exhaled breath condensate collection and blood draw in people with Healthy, run by National Heart Centre Singapore at 1 site in Singapore.
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 3 inclusion and 18 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 20 Apr 2025. 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 Singapore. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
No of participant with IL-11 detected in EBC and/or blood (time frame: 2 years). 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 NCT05536375, which also lists 7 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 20 Apr 2025.