Status:
RECRUITING
Biological Effects of Quercetin in COPD Phase II
Lead Sponsor:
Temple University
Collaborating Sponsors:
National Center for Complementary and Integrative Health (NCCIH)
Quercegen Pharmaceuticals
Conditions:
Chronic Obstructive Pulmonary Disease
Emphysema
Eligibility:
All Genders
40-80 years
Phase:
PHASE2
Brief Summary
This study determines whether quercetin supplementation reduces the inflammation and oxidative stress markers in patients with chronic obstructive pulmonary disease. It is small study with 8 subjects ...
Detailed Description
Chronic obstructive pulmonary disease (COPD) is a progressive lung disorder and affects millions of people globally. Although the exact mechanisms of pathogenesis of this disease are not well-understo...
Eligibility Criteria
Inclusion
- Subjects with COPD, 40 - 80 yrs of age
- Post-bronchodilator forced expiratory volume (FEV)1/forced vital capacity (FVC) ratio 0.7, FEV1% predicted between 40 to 70
- Both active and ex-smokers with at least 10 pack-years history of smoking
- COPD patients taking H2 antagonists, loperamide or loratadine and willing to stop during the study period
Exclusion
- Known allergy/sensitivity to quercetin
- Subjects with primary current diagnosis of asthma
- Upper respiratory tract infection within two weeks of the screening visit
- Acute bacterial infection requiring antibiotics within two weeks of screening
- Emergency treatment or hospitalization within one month of screening for any reasons
- Unwillingness to stop flavonoid supplementation
- Dietary intake exceeding or averaging 150 mg quercetin daily as assessed by Bioflavonoid Food and Supplement Screener
- Daily warfarin or cyclosporine (Neoral, Sandimmune)
- Subjects taking H2 antagonists (cimetidine, ranitidine), loperamide (Imodium) or loratadine and not willing to stop during study period
- Lung cancer history or undergoing chemo- or radiation therapy
- Inflammatory bowel disease
- Women of child-bearing age and unwilling to take pregnancy test
- Child-bearing age, who are unwilling to use adequate contraception or abstain during the course of the study.
- Pregnant or lactating mothers
Key Trial Info
Start Date :
November 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06003270
Start Date
November 1 2023
End Date
July 31 2025
Last Update
April 8 2024
Active Locations (1)
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1
Nathaniel Marchetti
Philadelphia, Pennsylvania, United States, 19140