Investigate the Effect of the CREON2000A on Asthma Control in Children With Mild to Moderate Persistent Asthma

Not Applicable

Completed

• Conditions: Asthma
• Interventions: Device: CREON2000A

• Registration Number: NCT02715375
• Lead Sponsor: General Innovations and Goods, Inc.

Brief Summary

This is a pivotal, 12-month, randomized, sham controlled, parallel group, multicenter, double blind study with an allocation ratio of 1:1. The study population is children between the ages 6 to 17 years, with mild to moderate persistent asthma. The purpose of the study is to determine whether the CREON2000A, an environmental control device, will decrease asthma severity, as measured by the Composite Asthma Severity Index (CASI), in children with mild to moderate persistent allergic asthma over a twelve month period.

Detailed Description

The pilot study (Protocol #PA-01-052; Health Effects of CREON2000 in Asthmatic Children. IB ID# GI 1001) offered preliminary evidence that the CREON2000A system may be beneficial in asthma. This study is a follow-up, using children, aged 6 to 17 with mild to moderate persistent asthma, as the subjects of the study. Children are usually treated with fewer controller medications and have fewer confounding co-morbidities making it more likely to detect a therapeutic benefit from an environmental intervention. The study will involve 4 study site visits, 2 home visits, and 7 phone calls. Adjustment of asthma therapy by the site clinician will occur at baseline (Visit 1) and at each follow-up office visit after Visit 1 using a modified algorithm based on the National Asthma Education and Prevention Program Expert Panel Report 3 (NAEPP EPR3) guidelines. Enrollment will be over 18 months. The study duration for each subject will be 12 months.

Study Timeline

• Study Start: 2016-03-10
• Study First Submitted: 2016-03-10
• Study First Submitted QC: 2016-03-16
• Study First Posted: 2016-03-22
• Status Verified: 2020-10
• Primary Completion: 2020-10-15
• Study Completion: 2020-10-15
• Disposition First Submitted: 2020-10-16
• Disposition First Submitted QC: 2020-10-16
• Disposition First Posted: 2020-10-22
• Last Update Submitted: 2020-10-30
• Last Update Posted: 2020-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 83

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Device: Sham Comparator	CREON2000A	Children with mild to moderate asthma maintains allergy medicines have a sham device using a shielded blue light sham lamp that otherwise resembles the experimental device installed in their homes.
Device: CREON2000A	CREON2000A	Children with mild to moderate asthma maintains allergy medicines have an experimental ultra violet device installed in their homes.

Primary Outcome Measures

Name	Time	Method
Change in CASI Score	Baseline and 12 months	Difference between study arms in the change in asthma severity as measured by the Composite Asthma Severity Index (CASI) from Baseline (Visit 1) to the 12-month follow up office visit

Secondary Outcome Measures

Name	Time	Method
Mean change in number of day time symptom scores	Baseline, 4, 8 and12 months	• in the mean change in number of day time symptom scores from Baseline (Visit 1) to the 4, 8 and 12-month follow up office visits
Change in Forced Expiratory Volume (FEV1)	Baseline and 12 months	• in the mean change in FEV1 (% predicted) from Baseline (Visit 1) to 12-month follow up office visit
Mean change in the number of daily puffs/inhalations of short-acting beta-agonist (SABA) rescue medication	Baseline, 4, 8 and 12 months	• in the mean change in the number of daily puffs/inhalations of short-acting beta-agonist rescue medication taken over 14 days prior to each evaluation, from Baseline (Visit 1) to 4, 8 and 12 month follow up office visits
Mean change in number of night time symptoms	Baseline, 4, 8 and 12 months	• in the mean change in number of night time symptom scores from Baseline (Visit 1) to the 4, 8 and 12-month follow up office visits
Mean change in daily does of inhaled glucocorticoids taken (µg/day)	Baseline 4, 8 and 12 months	• in the mean change in daily dose of inhaled glucocorticoids taken (µg/day) by participants from Baseline (Visit 1) to 4, 8 and 12 months follow up office visits.
Mean Change in CASI	Baseline, 4, 8 and 12 months	• in the mean change in CASI from Baseline (Visit 1) to 4- and 8- and 12-month follow up office visits
Mean change in the percentage of patients with an asthma exacerbation	Baseline and12 months	• in the mean change in the percentage of patients with an asthma exacerbation during the period from baseline (Visit 1) to the 12 month follow up office visit

Trial Locations

Locations (8)

Cincinnati Childrens Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States

Columbus Nationwide Children's Hospital; 🇺🇸 Columbus, Ohio, United States

Advanced Research Institute of Miami, LLC; 🇺🇸 Homestead, Florida, United States

Allergy & Asthma Associates; 🇺🇸 Lexington, Kentucky, United States

Bernstein Clinical Research Center, LLC; 🇺🇸 Cincinnati, Ohio, United States

Ohio Pediatric Research Assn.; 🇺🇸 Dayton, Ohio, United States

Toledo Institute of Clinical Research; 🇺🇸 Toledo, Ohio, United States

Great Lakes Medical Research, LLC; 🇺🇸 Willoughby, Ohio, United States