General Innovations and Goods, Inc. — Department of Health and Human Services SBIR Phase II: DESCRIPTION (provided by applicant): The purpose of this trial is to investigate the effec
General Innovations and Goods, Inc. — SBIR Phase II award from Department of Health and Human Services.
- Amount
- $2,971,610
- Agency
- Department of Health and Human Services · National Institutes of Health
- Program / Phase
- SBIR · Phase II
- Solicitation
- PAR13-250
- NAICS
- —
- Place of performance
- OH
- Period
- — → 2018-07-31
Description
DESCRIPTION (provided by applicant): 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