NCT04353310

Brief Summary

The purpose of this investigator-initiated study is to evaluate the effects of oral curcumin supplementation versus placebo in adult patients with moderate to severe asthma. Curcumin, a derivative of turmeric, has been shown in animal models to inhibit the secretion of pro-inflammatory cytokines and decrease airway constriction and hyperreactivity with only a few observational studies available in humans with discordant results.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2021

Shorter than P25 for phase_2 asthma

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 13, 2019

Completed
5 months until next milestone

First Posted

Study publicly available on registry

April 20, 2020

Completed
1.4 years until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 9, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 9, 2021

Completed
Last Updated

November 17, 2021

Status Verified

November 1, 2021

Enrollment Period

2 months

First QC Date

November 13, 2019

Last Update Submit

November 10, 2021

Conditions

Asthma

Keywords

asthmacurcumin

Outcome Measures

Primary Outcomes (1)

  • Asthma Control

    defined by the Asthma Control Test, which has a 5-point scale (for symptoms and activities: 1=all the time to 5= not at all; for asthma control rating: 1=not controlled at all to 5=completely controlled)

    3 months

Secondary Outcomes (6)

  • Number of Severe Asthma Exacerbations in 3 Months

    3 months

  • Cumulative Days Missed From School or Work in 3 Months

    3 months

  • Spirometry

    3 months

  • Exhaled nitric oxide

    3 months

  • Total IgE

    3 months

  • +1 more secondary outcomes

Study Arms (2)

Curcumin

EXPERIMENTAL
Drug: Curcumin

Placebo

PLACEBO COMPARATOR
Other: Placebo

Interventions

CurcuminDRUG

Curcumin 1500mg PO BID

Curcumin
PlaceboOTHER

identical in appearance to curcumin

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Provision of signed and dated informed consent form
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Male or female, aged 18 and older
  • Physician diagnosed moderate to severe asthma: (GINA 2018)
  • a. Stable asthma that requires ICS/LABA and/or an additional controller agent (i.e. LTRA, LAMA)
  • Ability to take oral medication and be willing to adhere to the regimen
  • Ability to speak and read English
  • If female and sexually active, should use effective forms of birth control

You may not qualify if:

  • Current use of turmeric (curcumin) or use within the last 7 days
  • Current use of biologic therapy/ immunotherapy/ or bronchothermoplasty
  • Pregnancy or lactation
  • Known allergic reactions to components of turmeric (curcumin)
  • Current use of anticoagulants, and history of coagulopathy or liver disease
  • INR greater than 2.0, PTT greater than 45.0 seconds

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (18)

  • Reddel HK, Taylor DR, Bateman ED, Boulet LP, Boushey HA, Busse WW, Casale TB, Chanez P, Enright PL, Gibson PG, de Jongste JC, Kerstjens HA, Lazarus SC, Levy ML, O'Byrne PM, Partridge MR, Pavord ID, Sears MR, Sterk PJ, Stoloff SW, Sullivan SD, Szefler SJ, Thomas MD, Wenzel SE; American Thoracic Society/European Respiratory Society Task Force on Asthma Control and Exacerbations. An official American Thoracic Society/European Respiratory Society statement: asthma control and exacerbations: standardizing endpoints for clinical asthma trials and clinical practice. Am J Respir Crit Care Med. 2009 Jul 1;180(1):59-99. doi: 10.1164/rccm.200801-060ST.

    PMID: 19535666BACKGROUND

  • Taylor DR, Bateman ED, Boulet LP, Boushey HA, Busse WW, Casale TB, Chanez P, Enright PL, Gibson PG, de Jongste JC, Kerstjens HA, Lazarus SC, Levy ML, O'Byrne PM, Partridge MR, Pavord ID, Sears MR, Sterk PJ, Stoloff SW, Szefler SJ, Sullivan SD, Thomas MD, Wenzel SE, Reddel HK. A new perspective on concepts of asthma severity and control. Eur Respir J. 2008 Sep;32(3):545-54. doi: 10.1183/09031936.00155307.

    PMID: 18757695BACKGROUND

  • Aggarwal BB, Surh YJ, Shishodia S (Eds.). Mol. Targets Ther. Uses Curcumin Health Dis, Springer, US. 2007; 1-75.

    BACKGROUND

  • Baldwin AS Jr. Series introduction: the transcription factor NF-kappaB and human disease. J Clin Invest. 2001 Jan;107(1):3-6. doi: 10.1172/JCI11891. No abstract available.

    PMID: 11134170BACKGROUND

  • Oh SW, Cha JY, Jung JE, Chang BC, Kwon HJ, Lee BR, Kim DY. Curcumin attenuates allergic airway inflammation and hyper-responsiveness in mice through NF-kappaB inhibition. J Ethnopharmacol. 2011 Jul 14;136(3):414-21. doi: 10.1016/j.jep.2010.07.026. Epub 2010 Jul 17.

    PMID: 20643202BACKGROUND

  • Liu L, Shang Y, Li M, Han X, Wang J, Wang J. Curcumin ameliorates asthmatic airway inflammation by activating nuclear factor-E2-related factor 2/haem oxygenase (HO)-1 signalling pathway. Clin Exp Pharmacol Physiol. 2015 May;42(5):520-9. doi: 10.1111/1440-1681.12384.

    PMID: 25739561BACKGROUND

  • Wong CK, Li ML, Wang CB, Ip WK, Tian YP, Lam CW. House dust mite allergen Der p 1 elevates the release of inflammatory cytokines and expression of adhesion molecules in co-culture of human eosinophils and bronchial epithelial cells. Int Immunol. 2006 Aug;18(8):1327-35. doi: 10.1093/intimm/dxl065. Epub 2006 Jun 23.

    PMID: 16798840BACKGROUND

  • Wuyts WA, Vanaudenaerde BM, Dupont LJ, Demedts MG, Verleden GM. Involvement of p38 MAPK, JNK, p42/p44 ERK and NF-kappaB in IL-1beta-induced chemokine release in human airway smooth muscle cells. Respir Med. 2003 Jul;97(7):811-7. doi: 10.1016/s0954-6111(03)00036-2.

    PMID: 12854631BACKGROUND

  • Kobayashi T, Hashimoto S, Horie T. Curcumin inhibition of Dermatophagoides farinea-induced interleukin-5 (IL-5) and granulocyte macrophage-colony stimulating factor (GM-CSF) production by lymphocytes from bronchial asthmatics. Biochem Pharmacol. 1997 Oct 1;54(7):819-24. doi: 10.1016/s0006-2952(97)00220-7.

    PMID: 9353136BACKGROUND

  • Ram A, Das M, Ghosh B. Curcumin attenuates allergen-induced airway hyperresponsiveness in sensitized guinea pigs. Biol Pharm Bull. 2003 Jul;26(7):1021-4. doi: 10.1248/bpb.26.1021.

    PMID: 12843631BACKGROUND

  • Kim DH, Phillips JF, Lockey RF. Oral curcumin supplementation in patients with atopic asthma. Allergy Rhinol (Providence). 2011 Apr;2(2):e51-3. doi: 10.2500/ar.2011.2.0016.

    PMID: 22852117BACKGROUND

  • Abidi A, Gupta S, Agarwal M, Bhalla HL, Saluja M. Evaluation of Efficacy of Curcumin as an Add-on therapy in Patients of Bronchial Asthma. J Clin Diagn Res. 2014 Aug;8(8):HC19-24. doi: 10.7860/JCDR/2014/9273.4705. Epub 2014 Aug 20.

    PMID: 25302215BACKGROUND

  • Gupta SC, Patchva S, Aggarwal BB. Therapeutic roles of curcumin: lessons learned from clinical trials. AAPS J. 2013 Jan;15(1):195-218. doi: 10.1208/s12248-012-9432-8. Epub 2012 Nov 10.

    PMID: 23143785BACKGROUND

  • Basnet P, Skalko-Basnet N. Curcumin: an anti-inflammatory molecule from a curry spice on the path to cancer treatment. Molecules. 2011 Jun 3;16(6):4567-98. doi: 10.3390/molecules16064567.

    PMID: 21642934BACKGROUND

  • Cheng AL, Hsu CH, Lin JK, Hsu MM, Ho YF, Shen TS, Ko JY, Lin JT, Lin BR, Ming-Shiang W, Yu HS, Jee SH, Chen GS, Chen TM, Chen CA, Lai MK, Pu YS, Pan MH, Wang YJ, Tsai CC, Hsieh CY. Phase I clinical trial of curcumin, a chemopreventive agent, in patients with high-risk or pre-malignant lesions. Anticancer Res. 2001 Jul-Aug;21(4B):2895-900.

    PMID: 11712783BACKGROUND

  • Lao CD, Ruffin MT 4th, Normolle D, Heath DD, Murray SI, Bailey JM, Boggs ME, Crowell J, Rock CL, Brenner DE. Dose escalation of a curcuminoid formulation. BMC Complement Altern Med. 2006 Mar 17;6:10. doi: 10.1186/1472-6882-6-10.

    PMID: 16545122BACKGROUND

  • Schatz M, Kosinski M, Yarlas AS, Hanlon J, Watson ME, Jhingran P. The minimally important difference of the Asthma Control Test. J Allergy Clin Immunol. 2009 Oct;124(4):719-23.e1. doi: 10.1016/j.jaci.2009.06.053. Epub 2009 Sep 19.

    PMID: 19767070BACKGROUND

  • Quan M, Alismail A, Daher N, Cleland D, Chavan S, Tan LD. Randomized, placebo controlled, double blinded pilot superiority phase 2 trial to evaluate the effect of curcumin in moderate to severe asthmatics. BMC Pulm Med. 2021 Aug 17;21(1):268. doi: 10.1186/s12890-021-01619-y.

    PMID: 34404358DERIVED

MeSH Terms

Conditions

Asthma

Interventions

Curcumin

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

DiarylheptanoidsHeptanesAlkanesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, Cyclic

Study Officials

  • Laren Tan, MD

    Loma Linda University Health

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2019

First Posted

April 20, 2020

Study Start

September 1, 2021

Primary Completion

November 9, 2021

Study Completion

November 9, 2021

Last Updated

November 17, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share