SBIR-STTR Award

The CREON2000 Photonic system is a high-efficiency ultraviolet air irradiation device. In a study funded by a Phase I SBIR grant, the CREON 2000 installed in the homes of children with allergic asthma was found to significantly improve pulmonary function (reduced Peak Flow variability (PEFRvar), increase Forced Expiratory Volume in 1 second (FEV1), and to reduce asthma medication use and symptom severity (shortness of breath, chest tightness, and number of days with symptoms) compared to a placebo sham unit. This NIAID Clinical Trial Planning Grant (R34) will allow for the development of a detailed clinical protocol designed to definitively demonstrate the efficacy of the CREON2000 in the treatment of mild to moderate persistent allergic asthma in children. The R34 grant will fund the complete planning of all phases of the clinical trial including development of materials that are in accordance with an ICH-compliant program that could enable FDA Pre-Market approval (PMA) of the CREON2000 as a Class 3 device for adjuvant therapy in the management of childhood asthma. The Clinical Trial Planning Team has extensive expertise in design and execution of clinical trials of this type, indoor environmental exposure assessment, and biostatistics. The PI and Co-PI will work closely with their team of experts to develop all documentation required for obtaining an NIAID Clinical Trial Implementation Cooperative Agreement (U01). The study design will be a placebo-controlled, double-blind, parallel group trial in children (ages 8 to 14) with mild to moderate persistent allergic asthma that uses the Asthma Control Questionnaire (ACQ) as the primary endpoint. Secondary endpoints will include home PEFR/FEV1 readings using a Piko-1 electronic device that captures and stores up to 90 readings, the asthma control diary, asthma symptom scores, asthma exacerbations, total asthma controller, and rescue medication use. The protocol design will be kept as simple as possible to maximize the number of patients that can be enrolled, thereby increasing the likelihood that a clinically and statistically significant signal can be detected. Investigating simple and cost-effective technology for improving asthma control in children is consistent with the objectives of the newly revised NAEPP guidelines. We believe that this application and the subsequent clinical trial, if funded, has important ramifications in understanding the effect of in-home central duct UV irradiation systems as a tertiary environmental intervention for the treatment of asthma.

Public Health Relevance:
PROJECT NARRATIVE This Grant will allow for the development of a detailed clinical protocol designed to definitively demonstrate the efficacy of the CREON2000 in the treatment of mild to moderate persistent allergic asthma in children. If successfully demonstrated, the CREON2000 will offer allergy and asthma sufferers a very cost effective and low maintenance way of controlling asthma and preventing deterioration of lung function over time.

Thesaurus Terms:
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The purpose of this trial is to investigate the effectiveness of the CREON2000A for improving asthma control and preventing or reducing asthma events in children with mild to moderate allergic asthma. The patented CREON2000A device is being developed as an environmental control intervention that will serve as an adjunctive treatment of asthma. The compact energy efficient design allows the use of the device in 95% of homes built after 1994, and in 74% of all US homes. Based on this statistics, the CREON2000A intervention, if efficacious, could benefit the majority of children with asthma in the United States. The promising results of our preliminary SBIR Phase I study warrant further investigation of this device in a larger clinical trial. This clinical trial is designed asa Phase II, multicenter, twelve month, double blind, randomized, sham controlled, parallel group study. It compares improvement in asthma control, as measured by the Asthma Control Questionnaire, in mild to moderate allergic persistent asthmatic children living in homes with a CREON2000A Irradiation system to those living in homes with sham units. Secondary endpoints of this trial are: morning peak expiratory flow rates, a reduction of total number of inhalation of rescue medications, asthma exacerbations, and missed days from school or work. The trial includes an exploratory objective designed to investigate whether CREON2000A's mechanism of action is related to protein structural changes by UV irradiation leading to the decreased allergenicity of indoor allergens. An interdisciplinary team of experienced, university and small business based researchers, with the necessary technical and clinical expertise has been assembled to investigate this potentially important asthma control intervention. The current approach for the management of asthma is very costly. In 2006, 8 billion dollars was spent treating childhood asthma. The annual cost per child for implementing multifaceted environmental control interventions, as recommended by the national asthma guidelines, ranges between $750 to $1,000 which is comparable to the annual cost of asthma medications. The necessity to modify behavior of parents, so they will maintain time-consuming and often expensive interventions, creates a significant barrier for adhering to these recommendations. The CREON2000A device requires minimal maintenance (i.e., changing bulb and small filter once a year) and, because it is simple to use, home occupants do not have to change their daily routines. For that reason, the acceptability and patient adherence with this intervention is excellent. The projected annual cost of this intervention including the amortization of the CREON2000A unit over 10 years is $244. Therefore, the application of this device and technology could optimize the medical management of asthma leading to a significant reduction in the costs associated with treating this chronic disease.

Public Health Relevance Statement:


Public Health Relevance:
The purpose of this clinical trial is to investigate the effectiveness of the CREON2000A, a novel UV irradiation system, at reducing asthma symptoms and exacerbations in children with mild to moderate allergic asthma. The CREON2000A is positioned to become the ideal adjunctive environmental control intervention treatment for asthma in children, because it has an excellent safety profile, requires minimal maintenance or effort to use by the patient or the patient's caregiver and is very cost effective.

Project Terms:
Address; Agonist; Air; Allergens; Allergic; Asthma; base; Breathing; Businesses; Caregivers; Child; Childhood Asthma; Chronic Disease; Clinical; Clinical Trials; Compliance behavior; cost; cost effective; design; Devices; Double-Blind Method; economic impact; Effectiveness; Electronics; Environmental air flow; Event; experience; Extrinsic asthma; Guidelines; Health; Home environment; Housing; improved; innovation; Intervention; Investigation; irradiation; Legal patent; Life; Light; Maintenance; Measures; Medical; novel; Office Visits; Parenting behavior; Patients; Peak Expiratory Flow Rate; Pharmaceutical Preparations; Phase; phase 1 study; Placebo Control; Positioning Attribute; Prevalence; prevent; public health relevance; Questionnaires; Randomized; Recommendation; Research Personnel; Safety; Schools; Small Business Innovation Research Grant; statistics; Structural Protein; Symptoms; System; Technology; Testing; Time; ultraviolet; ultraviolet irradiation; United States; Universities; Work