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OpenTrials
Completed

NCT Number: NCT01514266

Effect of Curcumin on Lung Inflammation

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.

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Key information

Conditions

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

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Medical Center

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Placebo

Drug

Primary outcomes

  1. Change in sputum dysplasia

    Time frame: 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 outcomes

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

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Baylor College of Medicine

Other

Collaborators

  • M.D. Anderson Cancer Center

Registry information

Important dates

Study start
2005
Primary completion
2007
Study completion
2010
First posted
Jan 23, 2012
Registry last updated
Jan 23, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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