ClinicalTrials.gg
RecruitingNCT06003270polyphenolsUpdated Apr 8, 2024

Biological Effects of Quercetin in COPD Phase II

A Phase 2 interventional study of Quercetin 1000 mg and Quercetin 500 MG in Chronic Obstructive Pulmonary Disease, Emphysema and Chronic Bronchitis With Airway Obstruction, sponsored by Temple University. Recruiting at 1 site in United States. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-04-08.

Sponsored by Temple University · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Feb 2025, 1 year 8 months ago, but the record still lists the study as recruiting.
  • Started Nov 2023; still recruiting 3 years later.
Phase
Phase 2
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
40 Years to 80 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 12 studies in Pulmonary Disease, Chronic Obstructive by Temple University — 5 open to participants now, 5 under way, none of them phase 3. Pulmonary Disease, Chronic Obstructive · Temple University.

Planned enrollment
6th of 10
30 · median 35
Started
2023
with 2 others
Phase 2
3 of 12
2 open now
Registered
11th of 12
by date

Among the 12 studies in Pulmonary Disease, Chronic Obstructive by Temple University, this one is the 6th largest by planned enrollment of the 10 interventional ones that give a count, is one of 3 that started in 2023, is one of 3 in phase 2, and was the 11th registered.

Pulmonary Disease, Chronic Obstructive

5,520 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 856 are open to participants now.

Browse Pulmonary Disease, Chronic Obstructive studies →

Open to participants now

5 of the 12 studies in Pulmonary Disease, Chronic Obstructive by Temple University are open now, in 2 countries. Recruiting first, the newest first:

By country, each count listing its studies:

All 5 open studies →

Where they have run

Who these studies take

Of the 555 Pulmonary Disease, Chronic Obstructive studies recruiting now, 305 (55%) set no upper age limit and 82 (15%) stop at 75 or younger; 29 take children under 18; 87 take healthy volunteers.

This study: 40 Years to 80 Years · all sexes · no healthy volunteers.

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02

Study 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 receiving quercetin 1000 mg/day, 8 patients receiving 500 mg/day and 4 subjects receive placebo.

Read the 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-understood, the general consensus is that oxidative stress and inflammation induced by exposure to cigarette smoke or other environmental or occupational hazards are responsible for development of COPD. Therefore, therapies aimed at decreasing oxidative stress and inflammation constitutes an important component of treating COPD.

The current pharmacological therapies may provide temporary symptom relief, reduce acute exacerbations and hospitalizations, but are associated with side effects. Therefore complementary method of treatment with potentially fewer side effects and relatively well-tolerated provide promising alternative. One such compound is quercetin, which is plant polyphenol and is present in variety of foods that we consume. Quercetin has potent antioxidant and anti-inflammatory properties and reduces oxidative stress and inflammation in a preclinical model of COPD. Quercetin exerts it antioxidant properties not only by neutralizing free radical species, but also by enhancing the expression of antioxidant enzymes. Similarly, quercetin inhibits various protein and lipid kinases by competing for adenosine triphosphate (ATP) binding sites thus reducing the inflammatory pathways.

03

Conditions studied

  • Chronic Obstructive Pulmonary Disease
  • Emphysema
  • Chronic Bronchitis With Airway Obstruction

Keywords

  • COPD, quercetin, polyphenol, mucus, airway obstruction
04

Who can participate

Ages eligible
40 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Subjects with , 40 - 80 yrs of age
  • Post-bronchodilator forced expiratory volume (FEV)1/forced vital capacity (FVC) ratio 0.7, % 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 criteria

Exclusion Criteria:

  • 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 or abstain during the course of the study.
  • Pregnant or lactating mothers
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

FEV1

From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
30 participants (estimated)

Study arms

  • Active comparator
    Quercetin 1000 mg/day

    Quercetin 1000 mg/day Quercetin is provided as caplet and each caplet will have 500 mg of quercetin Quercetin will be administered orally twice daily, one half dose (1 caplet) in the morning after breakfast and one half dose (1 caplet) in the evening after dinner for six months.

    Drug: Quercetin 1000 mg

  • Active comparator
    Quercetin 500mg/day

    Quercetin 500 mg/day Quercetin is provided as caplet and each caplet will have 500 mg of quercetin Quercetin will be administered orally once daily, (1 caplet) in the morning after breakfast and matching placebo in the evening after dinner for six months. The placebo is added to match the number of caplets with 1000 mg/day arm

    Drug: Quercetin 500 MG

  • Placebo comparator
    Placebo

    Placebo is also provided as caplets that is similar to quercetin in color, taste and texture and will contain all the stabilizers and the inactive ingredients that is present in the quercetin chews. Placebo will be administered orally twice daily, one half dose (1caplet) in the morning after breakfast and one half dose (1 caplet) in the evening after dinner for six months.

    Drug: Placebo

Interventions

06

What researchers measure

Primary outcomes

  1. C-reactive protein (CRP), and surfactant protein (SP)-D in serum

    The levels of these inflammatory markers will be measured at the time of recruitment (baseline) and after treatment with placebo or quercetin 500 g/day or 1000 mg/day in all the patients and

    Time frame: six months

  2. Club cell protein 16 (CC16) pg/ml

    The level of this anti-inflammatory marker in the serum will be measured at the time of recruitment (baseline) and after treatment with placebo, 500mg/day quercetin or 1000 mg/day quercetin

    Time frame: six months

Secondary outcomes

  1. Quercetin

    Concentration of quercetin in plasma will be determined at baseline and after treatment with study drugs

    Time frame: six months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • Ganesan S, Faris AN, Comstock AT, Chattoraj SS, Chattoraj A, Burgess JR, Curtis JL, Martinez FJ, Zick S, Hershenson MB, Sajjan US. Quercetin prevents progression of disease in elastase/LPS-exposed mice by negatively regulating MMP expression. Respir Res. 2010 Sep 28;11(1):131. doi: 10.1186/1465-9921-11-131. PubMed 20920189 ↗
  • Farazuddin M, Mishra R, Jing Y, Srivastava V, Comstock AT, Sajjan US. Quercetin prevents rhinovirus-induced progression of lung disease in mice with COPD phenotype. PLoS One. 2018 Jul 5;13(7):e0199612. doi: 10.1371/journal.pone.0199612. eCollection 2018. PubMed 29975735 ↗
  • Ganesan S, Faris AN, Comstock AT, Wang Q, Nanua S, Hershenson MB, Sajjan US. Quercetin inhibits rhinovirus replication in vitro and in vivo. Antiviral Res. 2012 Jun;94(3):258-71. doi: 10.1016/j.antiviral.2012.03.005. Epub 2012 Mar 23. PubMed 22465313 ↗
  • Han MK, Barreto TA, Martinez FJ, Comstock AT, Sajjan US. Randomised clinical trial to determine the safety of quercetin supplementation in patients with chronic obstructive pulmonary disease. BMJ Open Respir Res. 2020 Feb;7(1):e000392. doi: 10.1136/bmjresp-2018-000392. PubMed 32071149 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Nov 2023 (actual). Primary completion is estimated for Feb 2025, 15 months after the start.

Of 47 non-industry phase 2 interventional studies under Pulmonary Disease, Chronic Obstructive, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 63. This study's planned 15 months is below that.

Counting every sponsor, half of 165 studies reached it within 17 months; a quarter within 10 and three quarters within 31.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 15, 2023
First posted
Aug 21, 2023
StartActual
Nov 1, 2023
Primary completionEst.
Feb 15, 2025
CompletionEst.
Jul 31, 2025
Last update
Apr 8, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 8, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06003270
Lead sponsor
Temple University
Responsible party
Umadevi Sajjan (Associate Professor, Temple University) — Principal investigator
First posted
Aug 21, 2023
Start date
Nov 1, 2023
Primary completion
Feb 15, 2025 (estimated)
Completion
Jul 31, 2025 (estimated)
Last update
Apr 8, 2024

Study contacts

Umadevi Sajjan
Contact
uma.sajjan@temple.edu
2157077139
Nathaniel Marchetti
principal investigator · Temple University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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