Back to resultsEvaluating Effects of Curcumin in Moderate to Severe Asthmatics
Primary Purpose
Asthma
Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Curcumin
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Asthma focused on measuring asthma, curcumin
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Curcumin
Placebo
Arm Description
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Number of Severe Asthma Exacerbations in 3 Months
Cumulative Days Missed From School or Work in 3 Months
Spirometry
FEV1/FVC ratio, FEV1: forced expiratory volume in one second, FVC: forced vital capacity
Exhaled nitric oxide
Total IgE
Total plasma eosinophil count
Full Information
NCT ID
NCT04353310
First Posted
November 13, 2019
Last Updated
November 10, 2021
Sponsor
Loma Linda University
1. Study Identification
Unique Protocol Identification Number
NCT04353310
Brief Title
Evaluating Effects of Curcumin in Moderate to Severe Asthmatics
Official Title
Evaluating the Effects of Curcumin in Moderate to Severe Asthmatics
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Withdrawn
Why Stopped
No funding
Study Start Date
September 2021 (Anticipated)
Primary Completion Date
November 9, 2021 (Actual)
Study Completion Date
November 9, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Loma Linda University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
asthma, curcumin
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Curcumin
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Curcumin
Intervention Description
Curcumin 1500mg PO BID
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
identical in appearance to curcumin
Primary Outcome Measure Information:
Title
Asthma Control
Description
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)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Number of Severe Asthma Exacerbations in 3 Months
Time Frame
3 months
Title
Cumulative Days Missed From School or Work in 3 Months
Time Frame
3 months
Title
Spirometry
Description
FEV1/FVC ratio, FEV1: forced expiratory volume in one second, FVC: forced vital capacity
Time Frame
3 months
Title
Exhaled nitric oxide
Time Frame
3 months
Title
Total IgE
Time Frame
3 months
Title
Total plasma eosinophil count
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laren Tan, MD
Organizational Affiliation
Loma Linda University Health
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Evaluating Effects of Curcumin in Moderate to Severe Asthmatics
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