Health Effects of CREON2000 in Asthmatic Children

DESCRIPTIONprovided by applicantThe purpose of this trial is to investigate the effectiveness of the CREONA for improving asthma control and preventing or reducing asthma events in children with mild to moderate allergic asthmaThe patented CREONA device is being developed as an environmental control intervention that will serve as an adjunctive treatment of asthmaThe compact energy efficient design allows the use of the device inof homes built afterand inof all US homesBased on this statisticsthe CREONA interventionif efficaciouscould benefit the majority of children with asthma in the United StatesThe promising results of our preliminary SBIR Phase I study warrant further investigation of this device in a larger clinical trialThis clinical trial is designed asa Phase IImulticentertwelve monthdouble blindrandomizedsham controlledparallel group studyIt compares improvement in asthma controlas measured by the Asthma Control Questionnairein mild to moderate allergic persistent asthmatic children living in homes with a CREONA Irradiation system to those living in homes with sham unitsSecondary endpoints of this trial aremorning peak expiratory flow ratesa reduction of total number of inhalation of rescue medicationsasthma exacerbationsand missed days from school or workThe trial includes an exploratory objective designed to investigate whether CREONA s mechanism of action is related to protein structural changes by UV irradiation leading to the decreased allergenicity of indoor allergensAn interdisciplinary team of experienceduniversity and small business based researcherswith the necessary technical and clinical expertise has been assembled to investigate this potentially important asthma control interventionThe current approach for the management of asthma is very costlyInbillion dollars was spent treating childhood asthmaThe annual cost per child for implementing multifaceted environmental control interventionsas recommended by the national asthma guidelinesranges between $to $which is comparable to the annual cost of asthma medicationsThe necessity to modify behavior of parentsso they will maintain time consuming and often expensive interventionscreates a significant barrier for adhering to these recommendationsThe CREONA device requires minimal maintenancei echanging bulb and small filter once a yearandbecause it is simple to usehome occupants do not have to change their daily routinesFor that reasonthe acceptability and patient adherence with this intervention is excellentThe projected annual cost of this intervention including the amortization of the CREONA unit overyears is $Thereforethe 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