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Effect of Curcumin on Lung Inflammation

This study has been completed.
Sponsor:
Collaborator:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
Amir Sharafkhaneh, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT01514266
First received: January 12, 2012
Last updated: January 20, 2012
Last verified: January 2012
History of Changes
  Purpose

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.


Condition Intervention
Chronic Obstructive Pulmonary Disease
 Drug: Curcumin+Bioprine
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Effect of Curcumin on Lung Inflammation

Resource links provided by NLM:

Drug Information available for: Curcumin
U.S. FDA Resources

Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:
  • Change in sputum dysplasia [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Number of subjects with adverse events in each arm of the study. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 57
Study Start Date: April 2005
Study Completion Date: August 2010
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Curcumin+bioprine
The study involves active arm of Curcumin+Bioprine
 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.
Placebo Comparator: Placebo Drug: Placebo

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01514266

Locations
United States, Texas
VA Medical Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
M.D. Anderson Cancer Center
  More Information

No publications provided

Responsible Party: Amir Sharafkhaneh, Associate Professor of Medicine, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT01514266     History of Changes
Other Study ID Numbers: H-17419
Study First Received: January 12, 2012
Last Updated: January 20, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Baylor College of Medicine:
proven diagnosis
COPD
sputum

Additional relevant MeSH terms:
Inflammation
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Pneumonia
Lung Diseases, Obstructive
Pathologic Processes
Respiratory Tract Diseases
Respiratory Tract Infections
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 May 19, 2013