Study on the Efficacy of Quercetin Intake in Patients With Fibrotic Interstitial Lung Diseases.

NCT07466420 | Recruiting

• 1 other identifier: 247/23-12-2025
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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 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

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  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.

  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.

  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.

  Baseline, Week 32

Secondary Outcomes (7)

• Lung Oscillometry R5-R20 measurement

  Baseline, Week 32

• Change in X5 measurement

  Baseline, Week 32

• Change in FEV1 (mL)

  Baseline, Week 32

• Change in FEV1%

  Baseline, Week 32

• Change in KCO

  Baseline, Week 32

Other Outcomes (4)

• Change in TLC (mL)

  Baseline, Week 32

• Change in TLC%

  Baseline, Week 32

• Living with Pulmonary Fibrosis (L-PF) Questionnaires

  Baseline, Week 32

Study Arms (2)

Standard of care (SOC) treatment

ACTIVE COMPARATOR

Standard of care based on the specific ILD

Drug: Usual treatment

Quercetin (dietary supplement)

EXPERIMENTAL

Dietary Supplement: Quercetin (dietary supplement)

Interventions

Quercetin (dietary supplement) DIETARY_SUPPLEMENT

Quercetin tab 500mg, daily

Quercetin (dietary supplement)

Usual treatment DRUG

Antifibrotic or/and immunomodulatory treatment

Standard of care (SOC) treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Katerina M. Antoniou: lead

Study Sites (1)

Respiratory Department, University Hospital of Heraklion, School of Medicine, University of Crete

Heraklion, Crete, 71500, Greece

RECRUITING

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

Quercetin; Dietary Supplements

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Flavonols; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Katerina M. Antoniou, MD PhD, Professor

  Department of Respiratory Medicine, University Hospital of Heraklion, School of Medicine, University of Crete

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ioanna Argyriou, MSc

CONTACT

+302810371966; ioannaar07@gmail.com

Eirini Vasarmidi, MD MSc PhD, Ass. Professor

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Respiratory Medicine

Study Record Dates

• First Submitted: February 2, 2026
• First Posted: March 12, 2026
• Study Start: January 26, 2026
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): January 31, 2029
• Last Updated: March 12, 2026

Record last verified: 2026-03

Locations

GR (1)