Evaluating Effects of Curcumin in Moderate to Severe Asthmatics

Study Overview
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Brief Summary
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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.

Official Title
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Evaluating the Effects of Curcumin in Moderate to Severe Asthmatics

Conditions
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Asthma

Intervention / Treatment
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* Drug: Curcumin
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Curcumin<br> | Drug: Curcumin<br>* Curcumin 1500mg PO BID<br>|
| Placebo Comparator: Placebo<br> | Other: Placebo<br>* identical in appearance to curcumin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 3 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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asthma, curcumin