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

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.

Overview

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.

Interventions

• Dietary supplement Quercetin (dietary supplement)
  Quercetin tab 500mg, daily
• Drug Usual treatment
  Antifibrotic or/and immunomodulatory treatment

Primary outcome measures

• Change in Blood Leukocyte Telomere length [Time frame: Baseline, Week 32]
• Change in FeNO measurement [Time frame: Baseline, Week 32]
• Change in FVC (mL) [Time frame: Baseline, Week 32]
• Change in FVC% [Time frame: Baseline, 32 weeks.]
• Change in Diffusion Capacity for Carbon Monoxide (DLCO) [Time frame: Baseline, Week 32]
• Change in the Senescence-Associated Secretory Phenotype (SASP) [Time frame: Baseline, Week 32]

Secondary outcome measures (7)

• 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Greece · 1 center

• Respiratory Department, University Hospital of Heraklion, School of Medicine, University o — Heraklion

Identifiers

NCT: NCT07466420 · 247/23-12-2025

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗