Evaluating Effects of Curcumin in Moderate to Severe Asthmatics

Phase 2

Withdrawn

• Conditions: Asthma
• Interventions: Other: Placebo; Drug: Curcumin

• Registration Number: NCT04353310
• Lead Sponsor: Loma Linda University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-11-13
• Study First Submitted QC: 2020-04-16
• Study First Posted: 2020-04-20
• Study Start: 2021-09
• Status Verified: 2021-11
• Primary Completion: 2021-11-09
• Study Completion: 2021-11-09
• Last Update Submitted: 2021-11-10
• Last Update Posted: 2021-11-17

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Curcumin	Curcumin	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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