Curcumin in Management of Chronic Obstructive Pulmonary Disease

NCT04687449 | Unknown

• 1 other identifier: 19-1603
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

COPD

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 0 and 90

Secondary Outcomes (4)

• Performance on the 6-minute walk test (6MWT)

  Day 0 and 90

• Time to the first acute exacerbation of COPD

  6 months

• Relative risk of the acute COPD exacerbation

  6 months

• Relative risk of hospital admission for acute COPD exacerbation.

  6 months

Study Arms (2)

Active Comparator: Curcumin therapy added to standard COPD care

ACTIVE COMPARATOR

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.

Dietary Supplement: Curcumin therapy; Other: Standard care

Active Comparator: Placebo with Standard COPD care

ACTIVE COMPARATOR

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.

Other: Placebo; Other: Standard care

Interventions

Curcumin therapy DIETARY_SUPPLEMENT

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).

Active Comparator: Curcumin therapy added to standard COPD care

Placebo OTHER

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.

Active Comparator: Placebo with Standard COPD care

Standard care OTHER

The standard of care for COPD.

Active Comparator: Curcumin therapy added to standard COPD care; Active Comparator: Placebo with Standard COPD care

Eligibility Criteria

• Age: 40 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Danbury Hospital: lead

Study Sites (1)

Pulmonary and Sleep Medicine clinic

Danbury, Connecticut, 06810, United States

Location

Related Publications (16)

• Rabe KF, Watz H. Chronic obstructive pulmonary disease. Lancet. 2017 May 13;389(10082):1931-1940. doi: 10.1016/S0140-6736(17)31222-9. Epub 2017 May 11.

  PMID: 28513453 BACKGROUND

• Miravitlles M, Ribera A. Understanding the impact of symptoms on the burden of COPD. Respir Res. 2017 Apr 21;18(1):67. doi: 10.1186/s12931-017-0548-3.

  PMID: 28431503 BACKGROUND

• Shah T, Churpek MM, Coca Perraillon M, Konetzka RT. Understanding why patients with COPD get readmitted: a large national study to delineate the Medicare population for the readmissions penalty expansion. Chest. 2015 May;147(5):1219-1226. doi: 10.1378/chest.14-2181.

  PMID: 25539483 BACKGROUND

• Shishodia S, Potdar P, Gairola CG, Aggarwal BB. Curcumin (diferuloylmethane) down-regulates cigarette smoke-induced NF-kappaB activation through inhibition of IkappaBalpha kinase in human lung epithelial cells: correlation with suppression of COX-2, MMP-9 and cyclin D1. Carcinogenesis. 2003 Jul;24(7):1269-79. doi: 10.1093/carcin/bgg078. Epub 2003 May 9.

  PMID: 12807725 BACKGROUND

• Yuan J, Liu R, Ma Y, Zhang Z, Xie Z. Curcumin Attenuates Airway Inflammation and Airway Remolding by Inhibiting NF-kappaB Signaling and COX-2 in Cigarette Smoke-Induced COPD Mice. Inflammation. 2018 Oct;41(5):1804-1814. doi: 10.1007/s10753-018-0823-6.

  PMID: 29961171 BACKGROUND

• Suzuki M, Betsuyaku T, Ito Y, Nagai K, Odajima N, Moriyama C, Nasuhara Y, Nishimura M. Curcumin attenuates elastase- and cigarette smoke-induced pulmonary emphysema in mice. Am J Physiol Lung Cell Mol Physiol. 2009 Apr;296(4):L614-23. doi: 10.1152/ajplung.90443.2008. Epub 2009 Jan 23.

  PMID: 19168576 BACKGROUND

• Zhang M, Xie Y, Yan R, Shan H, Tang J, Cai Y, Yin J, Chen M, Zhang J, Yang X, Zhang Q, Li Y. Curcumin ameliorates alveolar epithelial injury in a rat model of chronic obstructive pulmonary disease. Life Sci. 2016 Nov 1;164:1-8. doi: 10.1016/j.lfs.2016.09.001. Epub 2016 Sep 4.

  PMID: 27600540 BACKGROUND

• Vecchi Brumatti L, Marcuzzi A, Tricarico PM, Zanin V, Girardelli M, Bianco AM. Curcumin and inflammatory bowel disease: potential and limits of innovative treatments. Molecules. 2014 Dec 16;19(12):21127-53. doi: 10.3390/molecules191221127.

  PMID: 25521115 BACKGROUND

• Daily JW, Yang M, Park S. Efficacy of Turmeric Extracts and Curcumin for Alleviating the Symptoms of Joint Arthritis: A Systematic Review and Meta-Analysis of Randomized Clinical Trials. J Med Food. 2016 Aug;19(8):717-29. doi: 10.1089/jmf.2016.3705.

  PMID: 27533649 BACKGROUND

• Jones PW. Interpreting thresholds for a clinically significant change in health status in asthma and COPD. Eur Respir J. 2002 Mar;19(3):398-404. doi: 10.1183/09031936.02.00063702.

  PMID: 11936514 BACKGROUND

• ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available.

  PMID: 12091180 BACKGROUND

• Solway S, Brooks D, Lacasse Y, Thomas S. A qualitative systematic overview of the measurement properties of functional walk tests used in the cardiorespiratory domain. Chest. 2001 Jan;119(1):256-70. doi: 10.1378/chest.119.1.256.

  PMID: 11157613 BACKGROUND

• Singh D, Agusti A, Anzueto A, Barnes PJ, Bourbeau J, Celli BR, Criner GJ, Frith P, Halpin DMG, Han M, Lopez Varela MV, Martinez F, Montes de Oca M, Papi A, Pavord ID, Roche N, Sin DD, Stockley R, Vestbo J, Wedzicha JA, Vogelmeier C. Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Lung Disease: the GOLD science committee report 2019. Eur Respir J. 2019 May 18;53(5):1900164. doi: 10.1183/13993003.00164-2019. Print 2019 May.

  PMID: 30846476 BACKGROUND

• Rennard S, Thomashow B, Crapo J, Yawn B, McIvor A, Cerreta S, Walsh J, Mannino D. Introducing the COPD Foundation Guide for Diagnosis and Management of COPD, recommendations of the COPD Foundation. COPD. 2013 Jun;10(3):378-89. doi: 10.3109/15412555.2013.801309.

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• Fung FY, Wong WH, Ang SK, Koh HL, Kun MC, Lee LH, Li X, Ng HJ, Tan CW, Zhao Y, Linn YC. A randomized, double-blind, placebo- controlled study on the anti-haemostatic effects of Curcuma longa, Angelica sinensis and Panax ginseng. Phytomedicine. 2017 Aug 15;32:88-96. doi: 10.1016/j.phymed.2017.04.004. Epub 2017 Apr 10.

  PMID: 28732813 BACKGROUND

• Liu AC, Zhao LX, Lou HX. Curcumin alters the pharmacokinetics of warfarin and clopidogrel in Wistar rats but has no effect on anticoagulation or antiplatelet aggregation. Planta Med. 2013 Jul;79(11):971-7. doi: 10.1055/s-0032-1328652. Epub 2013 Jun 27.

  PMID: 23807811 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Oleg Sostin, MD

  Danbury Hospital, Nuvance Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rakhee Agarwal, PhD

CONTACT

203-739-4932; rakhee.agarwal@nuvancehealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 10, 2020
• First Posted: December 29, 2020
• Study Start: January 1, 2022
• Primary Completion: December 15, 2023
• Study Completion: December 15, 2023
• Last Updated: July 9, 2021

Record last verified: 2021-07

Locations

US (1)