Chronic Obstructive Pulmonary DiseasePhase 2polyphenolsNCT06003270
Biological Effects of Quercetin in COPD Phase II
A Phase 2 study testing Quercetin 1000 mg and Quercetin 500 MG in people with Chronic Obstructive Pulmonary Disease and Emphysema, run by Temple University at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Emphysema, Chronic Bronchitis With Airway Obstruction
- What is being tested?
- Quercetin 1000 mg and Quercetin 500 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2023to 31 Jul 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Nathaniel Marchetti
Philadelphia, Pennsylvania, 19140
NATHANIEL MARCHETTI, D.O., 215-707-9929, nathaniel.marchetti@tuhs.temple.edu
Umadevi Sajjan, Ph.D, 2157077139, uma.sajjan@temple.edu
About this study
Official title: Effects of Quercetin on the Oxidative Stress and Inflammatory Markers in COPD Phase II
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.
- Conditions
- Chronic Obstructive Pulmonary Disease, Emphysema, Chronic Bronchitis With Airway Obstruction
- Being tested
- Quercetin 1000 mg, Quercetin 500 MG, Placebo
- Keywords
- COPD, quercetin, polyphenol, mucus, airway obstruction
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Emphysema, Airway Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quercetin 1000 mgDrug
Active comparator
Quercetin 500 MGDrug
Active comparator
PlaceboDrug
Placebo comparator
| Study group | Role | What they receive |
|---|---|---|
| Quercetin 1000 mg/day | Active comparator | 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. Receives: Drug: Quercetin 1000 mg |
| Quercetin 500mg/day | Active comparator | 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 Receives: Drug: Quercetin 500 MG |
| Placebo | Placebo comparator | 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: six months
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
Measured: six months
Secondary outcomes (1)
Quercetin
Concentration of quercetin in plasma will be determined at baseline and after treatment with study drugs
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start1 Nov 2023
- Primary completion15 Feb 2025 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double blinded placebo controlled study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), Quercegen Pharmaceuticals
- Responsible party
- Principal investigator, Umadevi Sajjan, Temple University
- Investigators
- Nathaniel Marchetti, Principal investigator, Temple University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06003270
- Sponsor's protocol ID
- 20190727
- Other IDs
- R33AT009991
- Acronym
- polyphenols
- Status last verified
- Apr 2024
- First submitted
- 15 Aug 2023
- Last updated
- 8 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
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 20920189Farazuddin 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 29975735Ganesan 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 22465313Han 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
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Quercetin on the Oxidative Stress and Inflammatory Markers in COPD Phase II
- ClinicalTrials.gov ID
- NCT06003270
- Acronym / sponsor ID
- polyphenols / 20190727
- Conditions
- Chronic Obstructive Pulmonary Disease, Emphysema, Chronic Bronchitis With Airway Obstruction
- Keywords
- COPD, quercetin, polyphenol, mucus, airway obstruction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), Quercegen Pharmaceuticals
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 15 Feb 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 21 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Double blinded placebo controlled study
| Arm | Type | Receives |
|---|---|---|
| Quercetin 1000 mg/day | Active comparator | Drug: Quercetin 1000 mgQuercetin 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. |
| Quercetin 500mg/day | Active comparator | Drug: Quercetin 500 MGQuercetin 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 |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo 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. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quercetin 1000 mgActive comparator | Drug | Quercetin 1000 mg/day |
| Quercetin 500 MGActive comparator | Drug | Quercetin 500mg/day |
| PlaceboPlacebo comparator | Drug | Placebo |
Primary outcome
C-reactive protein (CRP), and surfactant protein (SP)-D in serum
Time frame: six months
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
Club cell protein 16 (CC16) pg/ml
Time frame: six months
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
1 secondary outcome
Quercetin
Time frame: six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2024.
- Results publication: PubMed 20920189Ganesan 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.
- Results publication: PubMed 29975735Farazuddin 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.
- Results publication: PubMed 22465313Ganesan 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.
- Results publication: PubMed 32071149Han 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.
- Phase I clinical trials to determine the safety of quercetin supplementation in COPDLink provided by the sponsor.
- Biological Effects of Quercetin in COPDLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nathaniel Marchetti principal investigator
Temple University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Quercetin 1000 mg and Quercetin 500 MG in people with Chronic Obstructive Pulmonary Disease and Emphysema, run by Temple University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Umadevi Sajjan (2157077139, uma.sajjan@temple.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
C-reactive protein (CRP), and surfactant protein (SP)-D in serum (time frame: six months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06003270, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2024.