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History of Changes for Study: NCT01179256
Effect of Supplemental Oral Curcumin in Patients With Atopic Asthma (CURCUMIN)
Latest version (submitted August 10, 2010) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 August 10, 2010 None (earliest Version on record)
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Study NCT01179256
Submitted Date:  August 10, 2010 (v1)

Open or close this module Study Identification
Unique Protocol ID: curcumin
Brief Title: Effect of Supplemental Oral Curcumin in Patients With Atopic Asthma (CURCUMIN)
Official Title: Effect of Supplemental Oral Curcumin in Patients With Atopic Asthma
Secondary IDs:
Open or close this module Study Status
Record Verification: August 2009
Overall Status: Completed
Study Start: March 2009
Primary Completion: December 2009 [Actual]
Study Completion: March 2010 [Actual]
First Submitted: August 9, 2010
First Submitted that
Met QC Criteria:
August 10, 2010
First Posted: August 11, 2010 [Estimate]
Last Update Submitted that
Met QC Criteria:
August 10, 2010
Last Update Posted: August 11, 2010 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: University of South Florida
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
Brief 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 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.

Open or close this module Conditions
Conditions: Atopic Asthma
Keywords: ASTHMA
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 16 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: CURCUMIN
oral supplementation of curcumin 2000mg
Dietary Supplement: CURCUMIN
oral supplementation of curcumin 2000mg
Placebo Comparator: PLACEBO
oral PLACEBO TABLET
no intervention other than stopping study
no intervention other than stopping study
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Improvement in post-bronchodilator FEV1
Secondary Outcome Measures:
1. Improvement in Asthma Control Test (ACT) Score Decreased frequency of asthma exacerbation
2. 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)
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 60 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • 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)

Exclusion Criteria:

Open or close this module Contacts/Locations
Study Officials: RICHARD LOCKEY, MD
Principal Investigator
University of South Florida
Locations: United States, Florida
Usf Asthma Allergy and Immunology Cru
Tampa, Florida, United States, 33613
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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