Fibrotic Interstitial Lungs Diseases, Idiopathic Pulmonary Fibrosis (IPF), Progressive Pulmonary Fibrosis
Conditions
Brief summary
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_SUPPLEMENTQuercetin (dietary supplement)
Quercetin tab 500mg, daily
DRUGUsual treatment
Antifibrotic or/and immunomodulatory treatment
Sponsors
Katerina M. Antoniou
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Blood Leukocyte Telomere length | Baseline, Week 32 | Blood leukocyte telomere length will be measured at baseline and after quercetin administration to assess changes associated with the intervention. |
| Change in FeNO measurement | 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. |
| Change in FVC (mL) | Baseline, Week 32 | Changes from baseline in forced vital capacity (FVC), expressed in milliliters (mL) will be assessed at Week 32. |
| Change in FVC% | Baseline, 32 weeks. | Change from baseline in forced vital capacity (FVC), expressed in percent predicted (FVC%pred), will be assessed at Week 32. |
| Change in Diffusion Capacity for Carbon Monoxide (DLCO) | Baseline, Week 32 | Change from baseline in DLCO, expressed as percent predicted (DLCO% pred), will be evaluated at Week 32. |
| Change in the Senescence-Associated Secretory Phenotype (SASP) | 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
| Measure | Time frame | Description |
|---|---|---|
| Lung Oscillometry R5-R20 measurement | 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. |
| Change in X5 measurement | 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. |
| Change in FEV1 (mL) | Baseline, Week 32 | Change from baseline in forced expiratory volume in one second (FEV1), expressed in milliliters (mL). |
| Change in FEV1% | 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. |
| Change in KCO | 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. |
| White blood cell (WBC) count | Baseline, Week 32 | — |
| Blood monocyte count | Baseline, Week 32 | — |
Countries
Greece
Contacts
CONTACTIoanna Argyriou, MSc
CONTACTEirini Vasarmidi, MD MSc PhD, Ass. Professor
PRINCIPAL_INVESTIGATORKaterina M. Antoniou, MD PhD, Professor
Department of Respiratory Medicine, University Hospital of Heraklion, School of Medicine, University of Crete
Outcome results
None listed