In this double-blind, placebo-controlled trial, 120 patients with a diagnosis of COPD will be randomized to receive either a daily curcumin preparation or placebo for 90 days, in addition to the standard of care treatment. The outcomes will be compared between the study arms. No dose escalation will be used.
Chronic obstructive pulmonary disease (COPD) kills more than 3 million people worldwide every year. COPD is managed mainly by pharmacological therapy during the stable stage. Research illustrates many proven beneficial outcomes associated with the use of bronchodilators (beta-agonists and anticholinergics), inhaled and oral steroids to decrease the bronchial tree inflammation, some antibiotics, such as azithromycin, which have not only antibacterial but also some anti-inflammatory properties. However, these remedies have many limitations due to the development of adverse effects and resistance. Despite the treatment, symptoms related to COPD negatively affect patients' quality of life and limit their essential physical abilities, such as walking. Although achievements have been made in the management of COPD, exacerbation (worsening or flare up) remains a leading cause for hospital admission. COPD exacerbation adversely affects patients' quality of and creates a significant financial burden on the healthcare system nationally and on a local level. Hospitals with excess readmission ratios for COPD are penalized financially by the Centers for Medicare and Medicaid Services. In Danbury Hospital, about 15% of patients admitted for COPD exacerbation are readmitted within 30 days on average. Therefore, there is an urgent need for continued development of maintenance drugs for the treatment of COPD. Aside from the ordinary accepted pharmacological therapy approved for treatment of this chronic respiratory illness, some alternatives have pharmacologic properties that may potentially target the pathophysiologic processes involved in COPD. Curcumin, a well-known polyphenol, is an active component of a plant Curcuma longa, commonly known as turmeric. Turmeric has been used for centuries as a spice and has recently become a widely used dietary supplement. Curcumin is reported to have anti-inflammatory properties by inhibiting NF-κB activation and IL-8,4,5 which are known to promote white blood cell activity and expression of COX-2 (enzyme responsible for production of inflammatory cytokines) involved in the pathophysiology of COPD. It has also been associated with the inhibition of cigarette smoke-induced NF-κB activation in bronchial epithelium in mice; in addition, it has been shown to revitalize steroid response in human cells. The data on the effects of curcumin on inflammatory cytokines, as described above, has been derived from in vitro cell line and animal studies. While curcumin has been studied in humans for other inflammatory conditions (arthritis, gastrointestinal conditions, etc) to our knowledge, no human studies to explore its role in the management of COPD are available. As bronchial inflammation plays a key role in pathophysiology of COPD and curcumin has been shown to exhibit significant anti-inflammatory properties, we hypothesize that use of curcumin is associated with improvement in outcomes in patients with COPD. Primary objective 1\. To study if daily oral consumption of a curcumin preparation is associated with decreased health impairment in patients with COPD. Secondary objectives 1. To study if daily oral consumption of a curcumin preparation is associated with improved functional exercise capacity among patients with COPD. 2. To study if daily oral consumption of a curcumin preparation is associated with decreased risk of an acute COPD exacerbation, and related hospital admission, in patients with COPD.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
120
Clear capsules (made of vegetable cellulose) with turmeric extract (500 mg, 95% curcuminoids), Bioperine (5 mg, improves absorption), and inactive ingredients (microcrystalline cellulose, vegetable magnesium stearate, silicon dioxide).
Clear capsules (made of vegetable cellulose) with inactive ingredients (lactose monohydrate and food color); the capsules will be matched in size and color of the content to the preparation used in the Curcumin capsule.
The standard of care for COPD.
Pulmonary and Sleep Medicine clinic
Danbury, Connecticut, United States
St. George's Respiratory Questionnaire (SGRQ-C) score
Change in the 40-item version of the St. George's Respiratory Questionnaire (SGRQ-C) score: the score will be measured upon enrollment and at 90 days. It consists of 40 questions, and scored on 0 (no health impairment) to 100 (maximum health impairment) scale. The threshold for a clinically significant difference between groups of patients and for changes within groups of patients is four units.
Time frame: Day 0 and 90
Performance on the 6-minute walk test (6MWT)
Change in the 6-minute walk test (6MWT) result (in meters): the test will be administered upon enrollment and at 90 days.
Time frame: Day 0 and 90
Time to the first acute exacerbation of COPD
Difference in the time from initiation of the study medication to the first acute COPD exacerbation. Participants will be contacted over the phone 6 months after taking the first dose of the study medication, to inquire about outpatient and inpatient encounters for acute worsening of COPD occurred after the 90-day follow-up appointment; the participants' medical records will also be reviewed to determine if the reported encounters occurred due to acute COPD exacerbation as diagnosed by a medical provider and also to determine if COPD exacerbation occurred in those participants who could not be reached over the phone.
Time frame: 6 months
Relative risk of the acute COPD exacerbation
Relative risk of the acute COPD exacerbation occurred during the study will be analyzed descriptively by calculating average occurrence (number of incidences in population over the 6-month period) in both study groups. Participants will be contacted over the phone 6 months after taking the first dose of the study medication, to inquire about outpatient and inpatient encounters for acute worsening of COPD occurred after the 90-day follow-up appointment; the participants' medical records will also be reviewed to determine if the reported encounters occurred due to acute COPD exacerbation as diagnosed by a medical provider and also to determine if COPD exacerbation occurred in those participants who could not be reached over the phone.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 6 months
Relative risk of hospital admission for acute COPD exacerbation.
Relative risk of hospital admission for acute COPD exacerbation occurred during the study will be analyzed descriptively by calculating average occurrence (number of incidences in population over the 6-month period) in both study groups. Participants will be contacted over the phone 6 months after taking the first dose of the study medication, to inquire about outpatient and inpatient encounters for acute worsening of COPD occurred after the 90-day follow-up appointment; the participants' medical records will also be reviewed to determine if the reported encounters occurred due to acute COPD exacerbation as diagnosed by a medical provider and also to determine if COPD exacerbation occurred in those participants who could not be reached over the phone.
Time frame: 6 months