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.
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.
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.
Parallel
Quercetin (dietary supplement)
Dietary supplementQuercetin tab 500mg, daily
Usual treatment
DrugAntifibrotic or/and immunomodulatory treatment
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.
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.
Change in FVC (mL)
Changes from baseline in forced vital capacity (FVC), expressed in milliliters (mL) will be assessed at 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.
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.
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.
Change in FEV1 (mL)
Change from baseline in forced expiratory volume in one second (FEV1), expressed in milliliters (mL).
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.
Change in TLC (mL)
Change from baseline in total lung capacity (TLC) expressed in mililiters(ml) will be evaluated at Week 32.
Change in TLC%
Change from baseline in total lung capacity (TLC) expressed in percent predicted (%), will be evaluated at 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.
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.
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Katerina M. Antoniou
Lead sponsor
University of Crete
Sponsor institution
