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Effect of Curcumin on Lung Inflammation

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Curcumin+Bioprine

Placebo

About this trial

This is an interventional prevention trial for Chronic Obstructive Pulmonary Disease focused on measuring proven diagnosis, COPD, sputum

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

VA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Curcumin+bioprine

Placebo

Arm Description

The study involves active arm of Curcumin+Bioprine

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

NCT ID

NCT01514266

First Posted

January 12, 2012

Last Updated

January 20, 2012

Sponsor

Baylor College of Medicine

Collaborators

M.D. Anderson Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT01514266

Brief Title

Effect of Curcumin on Lung Inflammation

Official Title

Effect of Curcumin on Lung Inflammation

Study Type

Interventional

2. Study Status

Record Verification Date

January 2012

Overall Recruitment Status

Completed

Study Start Date

April 2005 (undefined)

Primary Completion Date

May 2007 (Actual)

Study Completion Date

August 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Baylor College of Medicine

Collaborators

M.D. Anderson Cancer Center

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Obstructive Pulmonary Disease

Keywords

proven diagnosis, COPD, sputum

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

57 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Curcumin+bioprine

Arm Type

Experimental

Arm Description

The study involves active arm of Curcumin+Bioprine

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Curcumin+Bioprine

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Change in sputum dysplasia

Description

Time Frame

3 months

Secondary Outcome Measure Information:

Title

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

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

VA Medical Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

12. IPD Sharing Statement

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Effect of Curcumin on Lung Inflammation

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