Effect of Supplemental Oral Curcumin in Patients With Atopic Asthma (CURCUMIN)

This study has been completed.
Sponsor:
Information provided by:
University of South Florida
ClinicalTrials.gov Identifier:
NCT01179256
First received: August 9, 2010
Last updated: August 10, 2010
Last verified: August 2009
  Purpose

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).


Condition Intervention
Atopic Asthma
Dietary Supplement: CURCUMIN
Other: no intervention other than stopping study

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Supplemental Oral Curcumin in Patients With Atopic Asthma

Resource links provided by NLM:


Further study details as provided by University of South Florida:

Primary Outcome Measures:
  • Improvement in post-bronchodilator FEV1 [ Time Frame: NOT SPECIFIED ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvement in Asthma Control Test (ACT) Score Decreased frequency of asthma exacerbation [ Time Frame: NOT SPECIFIED ] [ Designated as safety issue: No ]
  • 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) [ Time Frame: NOT SPECIFIED ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 16
Study Start Date: March 2009
Study Completion Date: March 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CURCUMIN
oral supplementation of curcumin 2000mg
Dietary Supplement: CURCUMIN
oral supplementation of curcumin 2000mg
Placebo Comparator: PLACEBO
oral PLACEBO TABLET
Other: no intervention other than stopping study
no intervention other than stopping study

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01179256

Locations
United States, Florida
Usf Asthma Allergy and Immunology Cru
Tampa, Florida, United States, 33613
Sponsors and Collaborators
University of South Florida
Investigators
Principal Investigator: RICHARD LOCKEY, MD USF
  More Information

No publications provided

Responsible Party: RICHARD F. LOCKEY, MD, UNIVERSITY OF SOUTH FLORIDA
ClinicalTrials.gov Identifier: NCT01179256     History of Changes
Other Study ID Numbers: curcumin
Study First Received: August 9, 2010
Last Updated: August 10, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of South Florida:
ASTHMA

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Curcumin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 20, 2014