Clinical trial NCT04353310: Evaluating Effects of Curcumin in Moderate to Severe Asthmatics
Official title: Evaluating the Effects of Curcumin in Moderate to Severe Asthmatics
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Asthma
Keywords: asthma
curcumin
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2020-04-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Asthma Control
timeFrame: 3 months
Secondary outcomes:
measure: Number of Severe Asthma Exacerbations in 3 Months
timeFrame: 3 months
measure: Cumulative Days Missed From School or Work in 3 Months
timeFrame: 3 months
measure: Spirometry
timeFrame: 3 months
measure: Exhaled nitric oxide
timeFrame: 3 months
measure: Total IgE
timeFrame: 3 months
measure: Total plasma eosinophil count
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Loma Linda University Health
name: Laren Tan, MD
role: PRINCIPAL_INVESTIGATOR
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