Asthma
Conditions
Keywords
asthma, curcumin
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.
Interventions
DRUGCurcumin
Curcumin 1500mg PO BID
OTHERPlacebo
identical in appearance to curcumin
Sponsors
Loma Linda University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Asthma Control | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative Days Missed From School or Work in 3 Months | 3 months | — |
| Spirometry | 3 months | FEV1/FVC ratio, FEV1: forced expiratory volume in one second, FVC: forced vital capacity |
| Number of Severe Asthma Exacerbations in 3 Months | 3 months | — |
| Total IgE | 3 months | — |
| Total plasma eosinophil count | 3 months | — |
| Exhaled nitric oxide | 3 months | — |
Outcome results
None listed