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

Asthma Clinical Trial

— CREON2000A  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02715375
• Other study ID #: U44-CRE-01
• Secondary ID: U44AI074918
• Status: Completed
• Phase: N/A
• Start date: March 10, 2016
• Est. completion date: October 15, 2020

Study information

• Verified date: October 2020
• Source: General Innovations and Goods, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: October 15, 2020
• Est. primary completion date: October 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

Inclusion criteria

1. Males and Females ages 6.0 to 17.0 years.

2. Subjects with a physician diagnosis of mild or moderate persistent asthma.

3. FEV1 = 60% predicted with = 12% improvement after bronchodilator therapy.

4. Must have evidence of; 1) serum specific IgE (immunocap) = .35 or 2) a positive skin prick test to one or more common indoor allergens including standardized house dust mite, cat, dog, cockroach, mouse in the past.

Exclusion criteria

1. Current smokers

2. Passive exposure to environmental tobacco smoke at home or active fireplaces and other sources of air particulates (wood burning stoves, kerosene heaters) at home.

3. Diagnosed by a physician with a chronic lung disease other than asthma.

4. Upper or lower respiratory infection within four weeks prior to enrollment.

5. Known to have any other chronic illness (besides asthma) that is not well controlled at the time of screening (Visit 1).

6. History of a life threatening asthma attack requiring cardiopulmonary support, intubation with ventilatory support, hospitalization in an intensive care unit or hospitalization for asthma within 6 months preceding study screening (Visit 1).

7. Participation in another investigational drug/device study within the past 3 months (not including chart or observational studies)

Related Conditions & MeSH terms

• Asthma

Intervention

Device:
• CREON2000A

Locations

Country	Name	City	State
United States	Bernstein Clinical Research Center, LLC	Cincinnati	Ohio
United States	Cincinnati Childrens Hospital Medical Center	Cincinnati	Ohio
United States	Columbus Nationwide Children's Hospital	Columbus	Ohio
United States	Ohio Pediatric Research Assn.	Dayton	Ohio
United States	Advanced Research Institute of Miami, LLC	Homestead	Florida
United States	Allergy & Asthma Associates	Lexington	Kentucky
United States	Toledo Institute of Clinical Research	Toledo	Ohio
United States	Great Lakes Medical Research, LLC	Willoughby	Ohio

Sponsors (4)

Lead Sponsor	Collaborator
General Innovations and Goods, Inc.	Bernstein Clinical Research Center, National Institute of Allergy and Infectious Diseases (NIAID), University of Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in CASI Score	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	Baseline and 12 months
Secondary	Change in Forced Expiratory Volume (FEV1)	• in the mean change in FEV1 (% predicted) from Baseline (Visit 1) to 12-month follow up office visit	Baseline and 12 months
Secondary	Mean change in number of day time symptom scores	• 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	Baseline, 4, 8 and12 months
Secondary	Mean change in number of night time symptoms	• 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	Baseline, 4, 8 and 12 months
Secondary	Mean change in the number of daily puffs/inhalations of short-acting beta-agonist (SABA) rescue medication	• 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	Baseline, 4, 8 and 12 months
Secondary	Mean Change in CASI	• in the mean change in CASI from Baseline (Visit 1) to 4- and 8- and 12-month follow up office visits	Baseline, 4, 8 and 12 months
Secondary	Mean change in daily does of inhaled glucocorticoids taken (µg/day)	• 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.	Baseline 4, 8 and 12 months
Secondary	Mean change in the percentage of patients with an asthma exacerbation	• 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	Baseline and12 months