Effect of Supplemental Oral Curcumin in Patients With Atopic Asthma

NCT01179256 | Completed DMC

• 1 other identifier: curcumin
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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).

Conditions

Atopic Asthma

Keywords

ASTHMA

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (2)

CURCUMIN

EXPERIMENTAL

oral supplementation of curcumin 2000mg

Dietary Supplement: CURCUMIN

PLACEBO

PLACEBO COMPARATOR

oral PLACEBO TABLET

Other: no intervention other than stopping study

Interventions

CURCUMIN DIETARY_SUPPLEMENT

oral supplementation of curcumin 2000mg

CURCUMIN

no intervention other than stopping study OTHER

no intervention other than stopping study

PLACEBO

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

Sponsors & Collaborators

• University of South Florida: lead

Study Sites (1)

Usf Asthma Allergy and Immunology Cru

Tampa, Florida, 33613, United States

Location

MeSH Terms

Conditions

Asthma

Interventions

Curcumin

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Study Officials

• RICHARD LOCKEY, MD

  University of South Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 9, 2010
• First Posted: August 11, 2010
• Study Start: March 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: March 1, 2010
• Last Updated: August 11, 2010

Record last verified: 2009-08

Locations

US (1)