Health Effects of CREON2000 In Asthmatic Children

Period of Performance: 04/03/2009 - 09/30/2010

$225K

Phase 1 SBIR

Recipient Firm

General Innovations and Goods, Inc.
Columbus, OH 43209
Principal Investigator

Abstract

DESCRIPTION (provided by applicant): 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.