Effect of Curcumin on Lung Inflammation

NCT01514266 | Completed

• 1 other identifier: H-17419
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

proven diagnosis; COPD; sputum

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of subjects with adverse events in each arm of the study.

  3 months

Study Arms (2)

Curcumin+bioprine

EXPERIMENTAL

The study involves active arm of Curcumin+Bioprine

Drug: Curcumin+Bioprine

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Curcumin+Bioprine DRUG

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.

Curcumin+bioprine

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age equal or more than 45 with moderate COPD: FEV1/FVC ratio less than 70 percent; post bronchodilator FEV1 less than 50 percent
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Baylor College of Medicine: lead
• M.D. Anderson Cancer Center: collaborator

Study Sites (1)

VA Medical Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: January 12, 2012
• First Posted: January 23, 2012
• Study Start: April 1, 2005
• Primary Completion: May 1, 2007
• Study Completion: August 1, 2010
• Last Updated: January 23, 2012

Record last verified: 2012-01

Locations

US (1)