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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of care (SOC) treatment | Active Comparator | Standard of care based on the specific ILD |
|
| Quercetin (dietary supplement) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quercetin (dietary supplement) | Dietary Supplement | Quercetin tab 500mg, daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. | 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. | Baseline, Week 32 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Week 32 |
| Change in X5 measurement |
| Measure | Description | Time Frame |
|---|---|---|
| Change in TLC (mL) | Change from baseline in total lung capacity (TLC) expressed in mililiters(ml) will be evaluated at Week 32. | Baseline, Week 32 |
| Change in TLC% | Change from baseline in total lung capacity (TLC) expressed in percent predicted (%), will be evaluated at Week 32. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ioanna Argyriou, MSc | Contact | +302810371966 | ioannaar07@gmail.com | |
| Eirini Vasarmidi, MD MSc PhD, Ass. Professor | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Katerina M. Antoniou, MD PhD, Professor | Department of Respiratory Medicine, University Hospital of Heraklion, School of Medicine, University of Crete | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Respiratory Department, University Hospital of Heraklion, School of Medicine, University of Crete | Recruiting | Heraklion | Crete | 71500 | Greece |
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| Usual treatment | Drug | Antifibrotic or/and immunomodulatory treatment |
|
X5 (Reactance at 5 HZ) reflects lung elasticity and peripheral airway function. X5 change at week 32 will be assessed after quercetin administration.
| Baseline, Week 32 |
| Change in FEV1 (mL) | Change from baseline in forced expiratory volume in one second (FEV1), expressed in milliliters (mL). | 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. | 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. | Baseline, Week 32 |
| White blood cell (WBC) count | Baseline, Week 32 |
| Blood monocyte count | Baseline, Week 32 |
| Baseline, 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. | Baseline, Week 32 |
| 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. | Baseline, Week 32 |
| ID | Term |
|---|---|
| D054990 | Idiopathic Pulmonary Fibrosis |
| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D011794 | Quercetin |
| D019587 | Dietary Supplements |
| ID | Term |
|---|---|
| D044948 | Flavonols |
| D005419 | Flavonoids |
| D002867 | Chromones |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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