Randomized, placebo controlled, double blinded pilot superiority phase 2 trial to evaluate the effect of curcumin in moderate to severe asthmatics

Abstract

Background Curcumin, a derivative of the spice turmeric, has been adopted by Eastern medicine for centuries as an adjunct to treat several medical conditions (e.g., anorexia and arthritis) because of its well-established anti-inflammatory properties. Studies have shown that the use of curcumin in mice models has led to reduction in several inflammatory markers as well as key inflammatory pathway enzymes. As a result, studies in Western medicine have developed to determine if this recognized benefit can be utilized for patients with inflammatory lung diseases, such as asthma. This study will seek to better understand if curcumin can be used as an adjunctive therapy for improving asthma control of patients with moderate to severe asthma; a finding we hope will allow for a more affordable treatment. Methods This study will utilize a randomized, placebo controlled, double blinded pilot superiority phase 2 trial at an outpatient pulmonary clinic in Southern California, USA. Subjects will be receiving Curcumin 1500 mg or matching placebo by mouth twice daily for the study period of 12 weeks. Subjects will be randomized to either a placebo or intervention Curcumin. Subjects will have 6 clinic visits: screening visit, a baseline visit, monthly clinic visits (weeks 4, 8, and 12), at weeks 4, 8, and a follow-up clinic visit or phone-call (week 16). Changes in asthma control test scores, number of days missed from school/work, FEV1 (% predicted), FEV1/FVC ratio, FVC (% predicted), blood eosinophil count, blood total IgE, and FeNO levels will be compared by group over time. Discussion The therapeutic effects of curcumin have been studied on a limited basis in asthmatics and has shown mixed results thus far. Our study hopes to further establish the benefits of curcumin, however, there are potential issues that may arise from our study design that we will address within this paper. Moreover, the onset of the COVID-19 pandemic has resulted in safety concerns that have delayed initiation of our study. This study will contribute to existing literature on curcumin’s role in reducing lung inflammation as it presents in asthmatics as well as patients suffering from COVID-19. Trial registration This study protocol has been approved by the Institutional Review Board at Loma Linda University Health, (NCT04353310). IND# 145101 Registered April 20th, 2020. https://clinicaltrials.gov/ct2/show/NCT04353310.

The Differential Antagonistic Ability of Curcumin against Cytotoxicity and Genotoxicity Induced by Distinct Heavy Metals

“…Recent studies have demonstrated that curcumin can protect against Cd-induced damage by activating the anti-oxidative signaling pathway of Nrf2/ARE [ 7 , 50 ] Curcumin could reduce the neurotoxicity and tissue damage elicited by Cd and Pb by chelating these heavy metals. [ 42 , 51 ]. Due to its excellent activity of scavenging intracellular ROS activity, curcumin could be used as an effective antioxidant for the protection of polar ROS induced by heavy metals in the cytoplasm [ 28 ].…”

Role of dietary supplements in the treatment of asthma - a narrative review

“…55 There are plans to conduct clinical trials in order to evaluate effect of using curcumin in asthmatic patients. 56 Such studies would prove useful in assessing measurable effects of supplementing curcumin and its influence on asthma control in humans. Beneficial effect of omega-3 fatty acids is also mediated by free fatty acid receptor 4 (FFA4).…”

Dietary Polyphenols—Natural Bioactive Compounds with Potential for Preventing and Treating Some Allergic Conditions

“…In addition, administration of nutraceutical dietary supplements containing curcumin with resveratrol, soy phospholipids, zinc, selenium, and vitamin D in children with moderate to severe asthma was found to mitigate allergic airway inflammation as expressed by decreased fractional exhaled nitric oxide level [276]. Supplementation with high doses of curcumin (1500 mg twice daily) for 12 weeks is currently being investigated in a phase 2 clinical trial to evaluate the effect on moderate to severe asthma in adults; however, no data are available for review to date [277]. No side effects [263] Based on the findings from in vitro studies indicating the immunomodulatory activities of flavonoids, these polyphenolic compounds should also be considered as po-tentially effective preventive and therapeutic agents for asthma [251].…”