Effect of Curcumin on Lung Inflammation

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Curcumin on Lung Inflammation

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Drug: Curcumin+Bioprine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Curcumin+bioprine<br>The study involves active arm of Curcumin+Bioprine | Drug: Curcumin+Bioprine<br>* 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.<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with adverse events in each arm of the study. |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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proven diagnosis, COPD, sputum