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

Katerina M. Antoniou100 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Fibrotic Interstitial Lungs Diseases

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Baseline, Week 32

Secondary Outcomes

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.

Time frame: 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.

Time frame: Baseline, Week 32

Change in FEV1 (mL)

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

Time frame: 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.

Time frame: 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.

Time frame: Baseline, Week 32

White blood cell (WBC) count

Time frame: Baseline, Week 32

Blood monocyte count

Time frame: Baseline, Week 32

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts