Evaluating Effects of Curcumin in Moderate to Severe Asthmatics

November 10, 2021 updated by: Loma Linda University

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Provision of signed and dated informed consent form
  2. Stated willingness to comply with all study procedures and availability for the duration of the study
  3. Male or female, aged 18 and older

  4. 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)

  5. Ability to take oral medication and be willing to adhere to the regimen
  6. Ability to speak and read English
  7. If female and sexually active, should use effective forms of birth control

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Other: Placebo
identical in appearance to curcumin
Experimental: Curcumin
Drug: Curcumin
Curcumin 1500mg PO BID

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Asthma Control
Time Frame: 3 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Severe Asthma Exacerbations in 3 Months
Time Frame: 3 months
3 months
Cumulative Days Missed From School or Work in 3 Months
Time Frame: 3 months
3 months
Spirometry
Time Frame: 3 months
FEV1/FVC ratio, FEV1: forced expiratory volume in one second, FVC: forced vital capacity
3 months
Exhaled nitric oxide
Time Frame: 3 months
3 months
Total IgE
Time Frame: 3 months
3 months
Total plasma eosinophil count
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Loma Linda University

Investigators

  • Principal Investigator: Laren Tan, MD, Loma Linda University Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2021

Primary Completion (Actual)

November 9, 2021

Study Completion (Actual)

November 9, 2021

Study Registration Dates

First Submitted

November 13, 2019

First Submitted That Met QC Criteria

April 16, 2020

First Posted (Actual)

April 20, 2020

Study Record Updates

Last Update Posted (Actual)

November 17, 2021

Last Update Submitted That Met QC Criteria

November 10, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5190424
  • 145101 (Other Identifier: FDA)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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