Curcumin in Management of Chronic Obstructive Pulmonary Disease

Danbury Hospital

Status

Unknown

Conditions

COPD

Treatments

Other: Standard care

Other: Placebo

Dietary Supplement: Curcumin therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT04687449

19-1603

Details and patient eligibility

About

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.

Full description

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

To study if daily oral consumption of a curcumin preparation is associated with decreased health impairment in patients with COPD.

Secondary objectives

To study if daily oral consumption of a curcumin preparation is associated with improved functional exercise capacity among patients with COPD.
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.

Enrollment

120 estimated patients

Sex

All

Ages

40 to 89 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Provision of signed and dated informed consent form by the subject.
Stated willingness to comply with all study procedures and availability for the duration of the study.
Clinical diagnosis of COPD, defined as having a smoking history of at least 10 pack-years, a ratio of post bronchodilator forced expiratory volume in 1 second [FEV1] to forced vital capacity of <70%, and a post bronchodilator FEV1 of <80% of the predicted value.
Patient has not had an acute exacerbation of COPD for at least 4 weeks of time of screening.

Exclusion criteria

Known allergic reactions to components of the study medication
Use of turmeric as a spice or a dietary supplement within 3 months prior to enrollment
Treatment with another investigational drug or other intervention at the time of enrollment
Pregnancy or lactation
Treatment with any chemotherapy agent, tacrolimus, talinolol, or sulfasalazine (due to the potential drug-drug interactions) at the time of enrolment
Short-term steroid course received, for any reason, within 4 weeks prior to enrollment
SGRQ-C is not available on the language preferred by the patient
Patient is not able to undergo 6-minute walk due to a non-COPD related reason

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

120 participants in 2 patient groups

Active Comparator: Curcumin therapy added to standard COPD care

Active Comparator group

Description:

Subjects will be given instructions to take 1 capsule twice daily for 90 days, 30 min before or 1 hour after meals, with a glass of water; if they develop upset stomach or diarrhea, then to take the medication with meals. This treatment will be in addition to the usual care that the hospital physician prescribe for them to treat the COPD.

Treatment:

Dietary Supplement: Curcumin therapy

Other: Standard care

Active Comparator: Placebo with Standard COPD care

Active Comparator group

Description:

Treatment:

Other: Placebo

Other: Standard care