Fibrotic Interstitial Lungs DiseasesNCT07466420
Study on the Efficacy of Quercetin Intake in Patients With Fibrotic Interstitial Lung Diseases.
A study testing Quercetin (dietary supplement) and Usual treatment in people with Fibrotic Interstitial Lungs Diseases and Idiopathic Pulmonary Fibrosis (IPF), run by Katerina M. Antoniou at 1 site in Greece.
Trial summary
Fibrotic interstitial lung diseases (F-ILDs), including both idiopathic pulmonary fibrosis (IPF) and non-IPF, are chronic and progressive lung diseases characterized by excessive scarring of lung tissue, leading to declining lung function, respiratory failure, and high mortality, despite the currently approved… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibrotic Interstitial Lungs Diseases, Idiopathic Pulmonary Fibrosis (IPF), Progressive Pulmonary Fibrosis
- What is being tested?
- Quercetin (dietary supplement) and Usual treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteGreece
- Study dates
- 26 Jan 2026to 31 Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with an established diagnosis of IPF and Fibrotic ILD and will be eligible to participate in the study.
- The use of the approved standard of care antifibrotic therapy, either nintedanib or pirfenidone, and immunosuppressive therapy will be allowed as standard of care.
Who cannot join
- Subjects with a result of FeNO>25 ppb will be excluded from the study to ensure that no other pulmonary diseases, such as asthma, are present.
- Patients who do not initiate quercetin within the first week after their baseline visit.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Eirini Vasarmidi, MD MSc PhD, Ass. Professor contact
Greece1 site, 1 recruiting
- Recruiting
Respiratory Department, University Hospital of Heraklion, School of Medicine, University of Crete
Heraklion, Crete, 71500
Ioanna Argyriou, MSc, +302810371966, ioannaar07@gmail.com
Eirini Vasarmidi, Ass. Professor, eirvasar@gmail.com
About this study
Official title: Study on the Efficacy of Quercetin Intake in Patients With Idiopathic Pulmonary Fibrosis and Non-Idiopathic Pulmonary Fibrosis. A Two-arm, Prospective Randomized Controlled Clinical Trial.
Fibrotic interstitial lung diseases (F-ILDs), including both idiopathic pulmonary fibrosis (IPF) and non-IPF, are chronic and progressive lung diseases characterized by excessive scarring of lung tissue, leading to declining lung function, respiratory failure, and high mortality, despite the currently approved antifibrotic treatment. While its exact cause remains unknown, pulmonary fibrosis is strongly linked to aging, genetic predisposition, environmental factors, and cellular senescence. Ongoing research aims to identify reliable biomarkers and develop targeted treatments to enhance patient outcomes.
This randomized controlled trial will examine the effects of quercetin supplementation (500 mg/day for two 12-week cycles, with one 8-week washout periods) on telomere length, senescence-associated secretory phenotype (SASP) factors, and lung function in patients with IPF and F-ILDs. A total of 100 patients will be recruited, with half receiving quercetin (despite their standard of care therapy) and the other half receiving standard care (SOC). Primary outcomes will include changes in telomere length, SASP protein levels (IL-6, MMPs), fractional exhaled nitric oxide (FeNO), spirometry (FVC decline), and oscillometry measurements. Additionally, quality of life will be assessed using the L-IPF Questionnaire.
This study aims to explore quercetin's potential to reduce fibrosis, decrease inflammation, and improve lung function in F-ILDs, offering new insights into potential novel strategies for F-ILD management.
- Conditions
- Fibrotic Interstitial Lungs Diseases, Idiopathic Pulmonary Fibrosis (IPF), Progressive Pulmonary Fibrosis
- Being tested
- Quercetin (dietary supplement), Usual treatment
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quercetin (dietary supplement)Dietary supplement
Quercetin tab 500mg, daily
Usual treatmentDrug
Antifibrotic or/and immunomodulatory treatment
| Study group | Role | What they receive |
|---|---|---|
| Standard of care (SOC) treatment | Active comparator | Standard of care based on the specific ILD Receives: Drug: Usual treatment |
| Quercetin (dietary supplement) | Experimental | Not described Receives: Dietary Supplement: Quercetin (dietary supplement) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Blood Leukocyte Telomere length
Blood leukocyte telomere length will be measured at baseline and after quercetin administration to assess changes associated with the intervention.
Measured: Baseline, Week 32
Change in FeNO measurement
Fractional exhaled nitric oxide (FeNO) level will be measured at baseline and at Week 32 to assess airway inflammation before and after quercetin administration.
Measured: Baseline, Week 32
Change in FVC (mL)
Changes from baseline in forced vital capacity (FVC), expressed in milliliters (mL) will be assessed at Week 32.
Measured: Baseline, Week 32
Change in FVC%
Change from baseline in forced vital capacity (FVC), expressed in percent predicted (FVC%pred), will be assessed at Week 32.
Measured: Baseline, 32 weeks.
Change in Diffusion Capacity for Carbon Monoxide (DLCO)
Change from baseline in DLCO, expressed as percent predicted (DLCO% pred), will be evaluated at Week 32.
Measured: Baseline, Week 32
Change in the Senescence-Associated Secretory Phenotype (SASP)
Changes in the Senescence-Associated Secretory Phenotype (SASP) will be assessed by measuring at baseline and at week 32, pro-inflammatory IL- 6, matrix metalloproteinase MMP-7 and KL-6.
Measured: Baseline, Week 32
Secondary outcomes (7)
Lung Oscillometry R5-R20 measurement
R5-R20 reflects the peripheral (small airway) resistance. Changes in R5-R20 will be assessed at week 32 after administration of the intervention.
Measured: Baseline, Week 32
Change in X5 measurement
X5 (Reactance at 5 HZ) reflects lung elasticity and peripheral airway function. X5 change at week 32 will be assessed after quercetin administration.
Measured: Baseline, Week 32
Change in FEV1 (mL)
Change from baseline in forced expiratory volume in one second (FEV1), expressed in milliliters (mL).
Measured: Baseline, Week 32
Change in FEV1%
Change from baseline in forced expiratory volume in one second (FEV1), expressed in percent predicted (FEV1 %), will be assessed at Week 32.
Measured: Baseline, Week 32
Change in KCO
Change from baseline in transfer coefficient of the lung for carbon monoxide (KCO), expressed as percent predicted (KCO % predicted), will be evaluated at Week 32.
Measured: Baseline, Week 32
White blood cell (WBC) count
Measured: Baseline, Week 32
Blood monocyte count
Measured: Baseline, Week 32
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start26 Jan 2026
- Primary completion31 Jan 2028 (estimated)
- Study completion31 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibrotic Interstitial Lungs DiseasesStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Katerina M. Antoniou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Katerina M. Antoniou, University of Crete
- Investigators
- Katerina M. Antoniou, MD PhD, Professor, Principal investigator, Department of Respiratory Medicine, University Hospital of Heraklion, School of Medicine, University of Crete
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07466420
- Sponsor's protocol ID
- 247/23-12-2025
- Status last verified
- Mar 2026
- First submitted
- 2 Feb 2026
- Last updated
- 12 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Efficacy of Quercetin Intake in Patients With Idiopathic Pulmonary Fibrosis and Non-Idiopathic Pulmonary Fibrosis. A Two-arm, Prospective Randomized Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT07466420
- Acronym / sponsor ID
- 247/23-12-2025
- Conditions
- Fibrotic Interstitial Lungs Diseases, Idiopathic Pulmonary Fibrosis (IPF), Progressive Pulmonary Fibrosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Katerina M. AntoniouUniversity, hospital or other
- Study start
- 26 Jan 2026 (actual)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 31 Jan 2029 (estimated)
- First posted
- 12 Mar 2026 (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.
Fibrotic interstitial lung diseases (F-ILDs), including both idiopathic pulmonary fibrosis (IPF) and non-IPF, are chronic and progressive lung diseases characterized by excessive scarring of lung tissue, leading to declining lung function, respiratory failure, and high mortality, despite the currently approved antifibrotic treatment. While its exact cause remains unknown, pulmonary fibrosis is strongly linked to aging, genetic predisposition, environmental factors, and cellular senescence. Ongoing research aims to identify reliable biomarkers and develop targeted treatments to enhance patient outcomes.
This randomized controlled trial will examine the effects of quercetin supplementation (500 mg/day for two 12-week cycles, with one 8-week washout periods) on telomere length, senescence-associated secretory phenotype (SASP) factors, and lung function in patients with IPF and F-ILDs. A total of 100 patients will be recruited, with half receiving quercetin (despite their standard of care therapy) and the other half receiving standard care (SOC). Primary outcomes will include changes in telomere length, SASP protein levels (IL-6, MMPs), fractional exhaled nitric oxide (FeNO), spirometry (FVC decline), and oscillometry measurements. Additionally, quality of life will be assessed using the L-IPF Questionnaire.
This study aims to explore quercetin's potential to reduce fibrosis, decrease inflammation, and improve lung function in F-ILDs, offering new insights into potential novel strategies for F-ILD management.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care (SOC) treatment | Active comparator | Drug: Usual treatmentStandard of care based on the specific ILD |
| Quercetin (dietary supplement) | Experimental | Dietary Supplement: Quercetin (dietary supplement) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with an established diagnosis of IPF and Fibrotic ILD and will be eligible to participate in the study.
- The use of the approved standard of care antifibrotic therapy, either nintedanib or pirfenidone, and immunosuppressive therapy will be allowed as standard of care.
Key exclusion criteria (2 listed)
- Subjects with a result of FeNO>25 ppb will be excluded from the study to ensure that no other pulmonary diseases, such as asthma, are present.
- Patients who do not initiate quercetin within the first week after their baseline visit.
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 |
|---|---|---|
| Quercetin (dietary supplement)Quercetin tab 500mg, daily | Dietary supplement | Quercetin (dietary supplement) |
| Usual treatmentAntifibrotic or/and immunomodulatory treatment | Drug | Standard of care (SOC) treatment |
Primary outcome
Change in Blood Leukocyte Telomere length
Time frame: Baseline, Week 32
Blood leukocyte telomere length will be measured at baseline and after quercetin administration to assess changes associated with the intervention.
Change in FeNO measurement
Time frame: Baseline, Week 32
Fractional exhaled nitric oxide (FeNO) level will be measured at baseline and at Week 32 to assess airway inflammation before and after quercetin administration.
Change in FVC (mL)
Time frame: Baseline, Week 32
Changes from baseline in forced vital capacity (FVC), expressed in milliliters (mL) will be assessed at Week 32.
Change in FVC%
Time frame: Baseline, 32 weeks.
Change from baseline in forced vital capacity (FVC), expressed in percent predicted (FVC%pred), will be assessed at Week 32.
Change in Diffusion Capacity for Carbon Monoxide (DLCO)
Time frame: Baseline, Week 32
Change from baseline in DLCO, expressed as percent predicted (DLCO% pred), will be evaluated at Week 32.
Change in the Senescence-Associated Secretory Phenotype (SASP)
Time frame: Baseline, Week 32
Changes in the Senescence-Associated Secretory Phenotype (SASP) will be assessed by measuring at baseline and at week 32, pro-inflammatory IL- 6, matrix metalloproteinase MMP-7 and KL-6.
7 secondary outcomes
Lung Oscillometry R5-R20 measurement
Time frame: Baseline, Week 32
Change in X5 measurement
Time frame: Baseline, Week 32
Change in FEV1 (mL)
Time frame: Baseline, Week 32
Change in FEV1%
Time frame: Baseline, Week 32
Change in KCO
Time frame: Baseline, Week 32
White blood cell (WBC) count
Time frame: Baseline, Week 32
Blood monocyte count
Time frame: Baseline, Week 32
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
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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.
Eirini Vasarmidi, MD MSc PhD, Ass. Professor contact
Katerina M. Antoniou, MD PhD, Professor principal investigator
Department of Respiratory Medicine, University Hospital of Heraklion, School of Medicine, University of Crete
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quercetin (dietary supplement) and Usual treatment in people with Fibrotic Interstitial Lungs Diseases and Idiopathic Pulmonary Fibrosis (IPF), run by Katerina M. Antoniou at 1 site in Greece.
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 2 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 12 Mar 2026. 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 Greece. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ioanna Argyriou, MSc (+302810371966, ioannaar07@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Blood Leukocyte Telomere length (time frame: Baseline, Week 32). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Mar 2026.