Effect of Curcumin on Lung Inflammation

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Effect of Curcumin on Lung Inflammation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01514266
• Other study ID #: H-17419
• Status: Completed
• Phase: N/A
• First received: January 12, 2012
• Last updated: January 20, 2012
• Start date: April 2005
• Est. completion date: August 2010

Study information

• Verified date: January 2012
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: August 2010
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pneumonia
• Pulmonary Disease, Chronic Obstructive

Intervention

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

Locations

Country	Name	City	State
United States	VA Medical Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Baylor College of Medicine	M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in sputum dysplasia	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.	3 months	No
Secondary	Number of subjects with adverse events in each arm of the study.		3 months	No