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NCT Number: NCT07466420

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

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.

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Key information

Conditions

Fibrotic Interstitial Lungs Diseases Idiopathic Pulmonary Fibrosis Idiopathic Pulmonary Fibrosis (IPF) Lung Diseases Lung Diseases, Interstitial Progressive Pulmonary Fibrosis Pulmonary Fibrosis Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Heraklion, Crete, 71500, Greece

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Quercetin (dietary supplement)

Dietary Supplement

Quercetin tab 500mg, daily

Usual treatment

Drug

Antifibrotic or/and immunomodulatory treatment

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Secondary outcomes

  1. Lung Oscillometry R5-R20 measurement

    Time frame: Baseline, Week 32

    R5-R20 reflects the peripheral (small airway) resistance. Changes in R5-R20 will be assessed at week 32 after administration of the intervention.

  2. Change in X5 measurement

    Time frame: Baseline, Week 32

    X5 (Reactance at 5 HZ) reflects lung elasticity and peripheral airway function. X5 change at week 32 will be assessed after quercetin administration.

  3. Change in FEV1 (mL)

    Time frame: Baseline, Week 32

    Change from baseline in forced expiratory volume in one second (FEV1), expressed in milliliters (mL).

  4. Change in FEV1%

    Time frame: Baseline, Week 32

    Change from baseline in forced expiratory volume in one second (FEV1), expressed in percent predicted (FEV1 %), will be assessed at Week 32.

  5. Change in KCO

    Time frame: Baseline, Week 32

    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.

  6. White blood cell (WBC) count

    Time frame: Baseline, Week 32

  7. Blood monocyte count

    Time frame: Baseline, Week 32

Other outcomes

  1. Change in TLC (mL)

    Time frame: Baseline, Week 32

    Change from baseline in total lung capacity (TLC) expressed in mililiters(ml) will be evaluated at Week 32.

  2. Change in TLC%

    Time frame: Baseline, Week 32

    Change from baseline in total lung capacity (TLC) expressed in percent predicted (%), will be evaluated at Week 32.

  3. Living with Pulmonary Fibrosis (L-PF) Questionnaires

    Time frame: Baseline, Week 32

    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.

  4. King's Brief Interstitial Lung Disease Questionnaire (KBILD) Questionnaire

    Time frame: Baseline, Week 32

    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.

Interested in participating?

Recruiting

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Katerina M. Antoniou

Other

Registry information

Official study 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.

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Mar 12, 2026
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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