AzTrials
AzTrials

AsthmaPhase 2NCT04353310

Evaluating Effects of Curcumin in Moderate to Severe Asthmatics

A Phase 2 study testing Curcumin in people with Asthma, run by Loma Linda University.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Asthma
What is being tested?
Curcumin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
No sites listed yet
Study dates
Sep 2021to 9 Nov 2021
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
  • 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

Who cannot join

  • 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

About this study

Official title: Evaluating the Effects of Curcumin in Moderate to Severe Asthmatics

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.

Conditions
Asthma
Being tested
Curcumin, Placebo
Keywords
asthma, curcumin
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CurcuminDrug

    Curcumin 1500mg PO BID

  • PlaceboOther

    identical in appearance to curcumin

Study groups in NCT04353310
Study groupRoleWhat they receive
CurcuminExperimentalNot described
Receives: Drug: Curcumin
PlaceboPlacebo comparatorNot described
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 3 months

Secondary outcomes (6)

  1. Number of Severe Asthma Exacerbations in 3 Months

    Measured: 3 months

  2. Cumulative Days Missed From School or Work in 3 Months

    Measured: 3 months

  3. Spirometry

    FEV1/FVC ratio, FEV1: forced expiratory volume in one second, FVC: forced vital capacity

    Measured: 3 months

  4. Exhaled nitric oxide

    Measured: 3 months

  5. Total IgE

    Measured: 3 months

  6. Total plasma eosinophil count

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2020
  2. Study startSep 2021 (estimated)
  3. Primary completion9 Nov 2021
  4. Study completion9 Nov 2021

Why it stopped: No funding

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04353310
Sponsor's protocol ID
5190424
Other IDs
145101
Status last verified
Nov 2021
First submitted
13 Nov 2019
Last updated
17 Nov 2021
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 19535666

  • 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.

    PubMed 18757695

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

  • 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.

    PubMed 11134170

  • 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.

    PubMed 20643202

  • 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.

    PubMed 25739561

  • 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.

    PubMed 16798840

  • 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.

    PubMed 12854631

  • 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.

    PubMed 9353136

  • 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.

    PubMed 12843631

  • 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.

    PubMed 22852117

  • 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.

    PubMed 25302215

  • 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.

    PubMed 23143785

  • 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.

    PubMed 21642934

  • 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.

    PubMed 11712783

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Curcumin in people with Asthma, run by Loma Linda University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 17 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Asthma Control (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04353310, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2021.

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