NCT Number: NCT07466420
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Heraklion, Crete, 71500, Greece
Location status: Recruiting
Eirini Vasarmidi, Ass. Professor
CONTACT
Ioanna Argyriou, MSc
CONTACT
Katerina M. Antoniou, Professor
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Quercetin tab 500mg, daily
Antifibrotic or/and immunomodulatory treatment
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.
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.
Time frame: Baseline, Week 32
Changes from baseline in forced vital capacity (FVC), expressed in milliliters (mL) will be assessed at Week 32.
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.
Time frame: Baseline, Week 32
Change from baseline in DLCO, expressed as percent predicted (DLCO% pred), will be evaluated at Week 32.
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.
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.
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.
Time frame: Baseline, Week 32
Change from baseline in forced expiratory volume in one second (FEV1), expressed in milliliters (mL).
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.
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.
Time frame: Baseline, Week 32
Time frame: Baseline, Week 32
Time frame: Baseline, Week 32
Change from baseline in total lung capacity (TLC) expressed in mililiters(ml) will be evaluated at Week 32.
Time frame: Baseline, Week 32
Change from baseline in total lung capacity (TLC) expressed in percent predicted (%), will be evaluated at Week 32.
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.
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.
Contact information is provided by the study sponsor or research team.
Eirini Vasarmidi, MD MSc PhD, Ass. Professor
CONTACT
Ioanna Argyriou, MSc
CONTACT
Katerina M. Antoniou
Other
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.
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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