Atopic AsthmaCURCUMINNCT01179256
Effect of Supplemental Oral Curcumin in Patients With Atopic Asthma
A study testing CURCUMIN in people with Atopic Asthma, run by University of South Florida at 1 site in United States.
Trial summary
Curcumin has antioxidant properties and in animal models has numerous molecular targets, many of which are intracellular, such as transcription factors AP-1 and NF. As such, it inhibits the secretion of both pro-inflammatory (TNF-, IL-6) and anti-inflammatory (IL-10) cytokines, possibly by inhibiting transcription… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Atopic Asthma
- What is being tested?
- CURCUMIN
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Mar 2010
- Phase
- Interventional
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Males and non-breastfeeding, non-pregnant females
- Aged 18-60 years
- History of physician-diagnosed asthma for 1 year or longer FEV1 60% pre-bronchodilator
- Currently on low or medium dose inhaled corticosteroids (see Appendix 1)
- Use of short-acting β-agonist ≥ 1 in the past 30 days (except for exercise) A ≥ 2+ skin-prick test prick-puncture test to Dermatophagoides pteronyssinus or Dermatophagoidesfarinae with appropriate positive/negative controls (historical is acceptable within 10 years)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Usf Asthma Allergy and Immunology Cru
Tampa, Florida, 33613
About this study
Curcumin has antioxidant properties and in animal models has numerous molecular targets, many of which are intracellular, such as transcription factors AP-1 and NF. As such, it inhibits the secretion of both pro-inflammatory (TNF-, IL-6) and anti-inflammatory (IL-10) cytokines, possibly by inhibiting transcription factors such as nuclear factor-B (NF-B) and activator protein-1 (AP-1) (Wong et al).
Read the detailed description
Research Design This is a randomized, double-blinded, placebo-controlled pilot study to evaluate the effects of oral supplementation of curcumin 2000mg, versus placebo, on patients with a history of stable persistent asthma and allergic sensitization.
Ng et al investigated mini-mental status exam (MMSE) scores in 1010 patients without dementia who reported ingesting varying quantities of curry. The authors found a statistically significant improvement in MMSE among patients who reported consuming curry "occasionally", "often, or "very often" (Ng et al). Curcumin is theorized to aid patients with dementia by improving innate immunity and by acting as an anti-inflammatory, antioxidant agent. In a double-blind, placebo-controlled trial of 34 elderly patients with Alzheimer's disease, patients were randomized to receive 0, 1, or 4 grams PO curcumin. While the study did not show significant slowing in cognitive decline over a 6 month period, the dosages were tolerated up to 4 grams without significant adverse effects (Baum et al).
Wong et al demonstrated an inhibitory effect of curcumin on cytokines produced by human cells stimulated by the addition of Dermatophagoides pteronynssinus (Der p1), the major allergen derived from this dust mite. The authors investigated the cytokine changes that occur in bronchial epithelial cells and eosinophils upon activation by Der p1 (increased IL-10, TNF-, IL-6, GM-CSF, and IL-1). Curcumin inhibited such activation. For example, the addition of curcumin decreased the production of IL-10 in Der p1-activated human epithelial/eosinophil co-culture cell lines. Additionally, the addition of curcumin to Der p1-activated eosinophil cell cultures decreased the release of IL-10, TNF-, and IL-1. of NF-B and AP-1 induced by addition of Der p1 in the control group. The authors theorized this occurred via inhibition of AP-1 (Wong et al).
Several additional studies highlight the effect of curcumin in vitro. Curcumin decreases the expression and release of eotaxin, MCP-1, and MCP-3 from IL-1-stimulated human airway smooth muscle cells (Wuyts et al). Additionally, curcumin added to Der f-stimulated lymphocyte cell cultures from allergic asthmatics inhibits Der f-induced lymphocyte proliferation and production of IL-2, IL-4, IL-5, and GM-CSF (Kobayashi et al). Ram et al sensitized guinea pigs with ovalbumin to establish airway hyperresponsiveness. There was a significant decrease in airway constriction and hyperreactivity when curcumin (20mg/kg) was added during the sensitization phase.
There are no clinical studies which have evaluated the effect of oral curcumin supplementation on asthma severity in allergic asthmatics or any in vivo studies in humans with asthma. Therefore, this is a pilot study to evaluate the effects of oral supplementation with curcumin on patients with persistent atopic asthma.
- Conditions
- Atopic Asthma
- Being tested
- CURCUMIN, no intervention other than stopping study
- Keywords
- ASTHMA
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CURCUMINDietary supplement
oral supplementation of curcumin 2000mg
no intervention other than stopping studyOther
no intervention other than stopping study
| Study group | Role | What they receive |
|---|---|---|
| CURCUMIN | Experimental | oral supplementation of curcumin 2000mg Receives: Dietary Supplement: CURCUMIN |
| PLACEBO | Placebo comparator | oral PLACEBO TABLET Receives: Other: no intervention other than stopping study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in post-bronchodilator FEV1
Secondary outcomes (2)
Improvement in Asthma Control Test (ACT) Score Decreased frequency of asthma exacerbation
Decreased blood eosinophil count Decreased serum total IgE Decreased in cumulative dose of daily inhaled corticosteroid Decrease serum-specific IgE to Dp and Df Changes in sputum intracellular cytokine profiles (TNF-α, IL-1β, IL-10, IL-4, and IL-5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2010 (estimated)
- Study startMar 2009
- Primary completionDec 2009
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic AsthmaStudies of the same condition, open and under way.
- More trials run by University of South FloridaThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Investigators
- RICHARD LOCKEY, MD, Principal investigator, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01179256
- Sponsor's protocol ID
- curcumin
- Acronym
- CURCUMIN
- Status last verified
- Aug 2009
- First submitted
- 9 Aug 2010
- Last updated
- 11 Aug 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Supplemental Oral Curcumin in Patients With Atopic Asthma
- ClinicalTrials.gov ID
- NCT01179256
- Acronym / sponsor ID
- CURCUMIN / curcumin
- Conditions
- Atopic Asthma
- Keywords
- ASTHMA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 11 Aug 2010 (estimated)
- 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.
Curcumin has antioxidant properties and in animal models has numerous molecular targets, many of which are intracellular, such as transcription factors AP-1 and NF. As such, it inhibits the secretion of both pro-inflammatory (TNF-, IL-6) and anti-inflammatory (IL-10) cytokines, possibly by inhibiting transcription factors such as nuclear factor-B (NF-B) and activator protein-1 (AP-1) (Wong et al).
Detailed description
Research Design This is a randomized, double-blinded, placebo-controlled pilot study to evaluate the effects of oral supplementation of curcumin 2000mg, versus placebo, on patients with a history of stable persistent asthma and allergic sensitization.
Ng et al investigated mini-mental status exam (MMSE) scores in 1010 patients without dementia who reported ingesting varying quantities of curry. The authors found a statistically significant improvement in MMSE among patients who reported consuming curry "occasionally", "often, or "very often" (Ng et al). Curcumin is theorized to aid patients with dementia by improving innate immunity and by acting as an anti-inflammatory, antioxidant agent. In a double-blind, placebo-controlled trial of 34 elderly patients with Alzheimer's disease, patients were randomized to receive 0, 1, or 4 grams PO curcumin. While the study did not show significant slowing in cognitive decline over a 6 month period, the dosages were tolerated up to 4 grams without significant adverse effects (Baum et al).
Wong et al demonstrated an inhibitory effect of curcumin on cytokines produced by human cells stimulated by the addition of Dermatophagoides pteronynssinus (Der p1), the major allergen derived from this dust mite. The authors investigated the cytokine changes that occur in bronchial epithelial cells and eosinophils upon activation by Der p1 (increased IL-10, TNF-, IL-6, GM-CSF, and IL-1). Curcumin inhibited such activation. For example, the addition of curcumin decreased the production of IL-10 in Der p1-activated human epithelial/eosinophil co-culture cell lines. Additionally, the addition of curcumin to Der p1-activated eosinophil cell cultures decreased the release of IL-10, TNF-, and IL-1. of NF-B and AP-1 induced by addition of Der p1 in the control group. The authors theorized this occurred via inhibition of AP-1 (Wong et al).
Several additional studies highlight the effect of curcumin in vitro. Curcumin decreases the expression and release of eotaxin, MCP-1, and MCP-3 from IL-1-stimulated human airway smooth muscle cells (Wuyts et al). Additionally, curcumin added to Der f-stimulated lymphocyte cell cultures from allergic asthmatics inhibits Der f-induced lymphocyte proliferation and production of IL-2, IL-4, IL-5, and GM-CSF (Kobayashi et al). Ram et al sensitized guinea pigs with ovalbumin to establish airway hyperresponsiveness. There was a significant decrease in airway constriction and hyperreactivity when curcumin (20mg/kg) was added during the sensitization phase.
There are no clinical studies which have evaluated the effect of oral curcumin supplementation on asthma severity in allergic asthmatics or any in vivo studies in humans with asthma. Therefore, this is a pilot study to evaluate the effects of oral supplementation with curcumin on patients with persistent atopic asthma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CURCUMIN | Experimental | Dietary Supplement: CURCUMINoral supplementation of curcumin 2000mg |
| PLACEBO | Placebo comparator | Other: no intervention other than stopping studyoral PLACEBO TABLET |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Males and non-breastfeeding, non-pregnant females
- Aged 18-60 years
- History of physician-diagnosed asthma for 1 year or longer FEV1 60% pre-bronchodilator
- Currently on low or medium dose inhaled corticosteroids (see Appendix 1)
- Use of short-acting β-agonist ≥ 1 in the past 30 days (except for exercise) A ≥ 2+ skin-prick test prick-puncture test to Dermatophagoides pteronyssinus or Dermatophagoidesfarinae with appropriate positive/negative controls (historical is acceptable within 10 years)
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| CURCUMINoral supplementation of curcumin 2000mg | Dietary supplement | CURCUMIN |
| no intervention other than stopping studyno intervention other than stopping study | Other | PLACEBO |
Primary outcome
Improvement in post-bronchodilator FEV1
2 secondary outcomes
Improvement in Asthma Control Test (ACT) Score Decreased frequency of asthma exacerbation
Decreased blood eosinophil count Decreased serum total IgE Decreased in cumulative dose of daily inhaled corticosteroid Decrease serum-specific IgE to Dp and Df Changes in sputum intracellular cytokine profiles (TNF-α, IL-1β, IL-10, IL-4, and IL-5)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2010.
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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.
RICHARD LOCKEY, MD principal investigator
University of South Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CURCUMIN in people with Atopic Asthma, run by University of South Florida 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 5 inclusion and 0 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: finished, as of the sponsor's last update on 11 Aug 2010. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in post-bronchodilator FEV1. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Aug 2010.