Chronic Obstructive Pulmonary Disease
Conditions
Keywords
proven diagnosis, COPD, sputum
Brief 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.
Interventions
DRUGCurcumin+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.
DRUGPlacebo
Sponsors
M.D. Anderson Cancer Center
Baylor College of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in sputum dysplasia | 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
| Measure | Time frame |
|---|---|
| Number of subjects with adverse events in each arm of the study. | 3 months |
Countries
United States
Outcome results
None listed