Effect of Curcumin on Lung Inflammation

Overview

Chronic obstructive pulmonary disease (COPD) and lung cancer are leading causes of death and health care use. Diffuse airways inflammation is seen in COPD and is thought to be the reason for deterioration of lung function in COPD. Currently there is no medication available that can modify or reduce this inflammation. Furthermore, from literature review it has been shown that chronic inflammation can result in cancerous changes. Curcumin is a food additive used for centuries. Several studies showed that curcumin suppress the different inflammatory pathways. Specially, the TNF-alpha and the NF kappa-b are down regulated by this substance. This study was designed to evaluate effect of combination of curcumin+Bioprine on sputum cytology in patients with COPD. This is double-blind randomized pilot study.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: May 2007

Interventions

  • Drug: Curcumin+Bioprine
    • The intervention arm is Curcumin+Bioprine at escalating doses of 1 gram of Curcumin and 5 mg of Bioprine bid for one month, then 1.5 grams of Curcumin and 5 mg of bioprine bid for one month, and finally 2 grams of curcumin with 5 mg of bioprine bid for additional one month.
  • Drug: Placebo

Arms, Groups and Cohorts

  • Experimental: Curcumin+bioprine
    • The study involves active arm of Curcumin+Bioprine
  • Placebo Comparator: Placebo

Clinical Trial Outcome Measures

Primary Measures

  • Change in sputum dysplasia
    • Time Frame: 3 months
    • We evaluated presence of moderate or worse dysplasia at baseline and each subsequent visits. The primary endpoint of this study is change in sputum cytological abnormality (moderate or worse dysplasia). The change will be comparison of 3-month follow up compared to baseline.

Secondary Measures

  • Number of subjects with adverse events in each arm of the study.
    • Time Frame: 3 months

Participating in This Clinical Trial

Inclusion Criteria

  • Age equal or more than 45 with moderate COPD: FEV1/FVC ratio less than 70 percent; post bronchodilator FEV1 less than 50 percent – 20 pack year cigarette smoking – Stable clinical course (symptoms/ medications) for 8 weeks – Fixed address/Not planning to leave – Being able to perform spirometry – Able to understand and consent Exclusion Criteria:

  • Other chronic respiratory diseases such as asthma, interstitial fibrosis, sarcoidosis – Heart failure NYH III & IV; symptomatic liver or renal failure – Dementia or other neurocognitive deficit preventing completion of symptom diary – Use of inhaled or systemic corticosteroids within 8 weeks of enrollment in the study

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Baylor College of Medicine
  • Collaborator
    • M.D. Anderson Cancer Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: Amir Sharafkhaneh, Associate Professor of Medicine – Baylor College of Medicine

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