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

Asthma Clinical Trial

Official title: A Double Blind, Randomized, Sham Controlled Trial to Investigate the Effect of the CREON2000A on Asthma Control in Children With Mild to Moderate Persistent Asthma

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Asthma

• NCT number: NCT02715375
• Study type: Interventional
• Source: General Innovations and Goods, Inc.
• Status: Completed
• Phase: N/A
• Start date: March 10, 2016
• Completion date: October 15, 2020