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

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.

Study Overview

• Status: Recruiting
• Conditions: Idiopathic Pulmonary Fibrosis (IPF); Progressive Pulmonary Fibrosis; Fibrotic Interstitial Lungs Diseases
• Intervention / Treatment: Drug: Usual treatment; Dietary supplement: Quercetin (dietary supplement)

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ioanna Argyriou, MSc; Phone Number: +302810371966; Email: ioannaar07@gmail.com
• Study Contact Backup: Name: Eirini Vasarmidi, MD MSc PhD, Ass. Professor

Study Locations

• Greece
  • Crete
    • Heraklion, Crete, Greece, 71500
      • Recruiting
      • Respiratory Department, University Hospital of Heraklion, School of Medicine, University of Crete
      • Contact: Ioanna Argyriou, MSc; Phone Number: +302810371966; Email: ioannaar07@gmail.com
      • Contact: Eirini Vasarmidi, Ass. Professor; Email: eirvasar@gmail.com
      • Principal Investigator: Katerina M. Antoniou, Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard of care (SOC) treatment; Standard of care based on the specific ILD	Drug: Usual treatment; Antifibrotic or/and immunomodulatory treatment
Experimental: Quercetin (dietary supplement)	Dietary supplement: Quercetin (dietary supplement); Quercetin tab 500mg, daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Baseline, Week 32
Change in FEV1 (mL)	Change from baseline in forced expiratory volume in one second (FEV1), expressed in milliliters (mL).	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.	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.	Baseline, Week 32
White blood cell (WBC) count		Baseline, Week 32
Blood monocyte count		Baseline, Week 32

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in TLC (mL)	Change from baseline in total lung capacity (TLC) expressed in mililiters(ml) will be evaluated at Week 32.	Baseline, Week 32
Change in TLC%	Change from baseline in total lung capacity (TLC) expressed in percent predicted (%), will be evaluated at Week 32.	Baseline, Week 32
Living with Pulmonary Fibrosis (L-PF) Questionnaires	L-PF questionnaire will be administered to the patients enrolled in the study at their baseline visit and during their 32 week visit. The questionnaire consist of 43 items covering both symptoms and impacts.	Baseline, Week 32
King's Brief Interstitial Lung Disease Questionnaire (KBILD) Questionnaire	The King's Brief Interstitial Lung Disease (KBILD) questionnaire is a 15-item, patient-completed measure of health-related quality of life in interstitial lung disease. It includes three domains-Psychological, Breathlessness and Activities, and Chest Symptoms-combined into a total score. Scores range from 0 to 100, with higher values indicating better health status.	Baseline, Week 32

Collaborators and Investigators

• Sponsor: Katerina M. Antoniou
• Investigators: Principal Investigator: Katerina M. Antoniou, MD PhD, Professor, Department of Respiratory Medicine, University Hospital of Heraklion, School of Medicine, University of Crete

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2026
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): January 31, 2029

Study Registration Dates

• First Submitted: February 2, 2026
• First Submitted That Met QC Criteria: March 9, 2026
• First Posted (Actual): March 12, 2026

Study Record Updates

• Last Update Posted (Actual): March 12, 2026
• Last Update Submitted That Met QC Criteria: March 9, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Interstitial; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pyrans; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Benzopyrans; Flavonols; Flavonoids; Chromones; Quercetin; Dietary Supplements
• Other Study ID Numbers: 247/23-12-2025

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No