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

Primary Purpose

Asthma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CREON2000A
Sponsored by
General Innovations and Goods, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring asthma environment

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Advanced Research Institute of Miami, LLC
  • Allergy & Asthma Associates
  • Cincinnati Childrens Hospital Medical Center
  • Bernstein Clinical Research Center, LLC
  • Columbus Nationwide Children's Hospital
  • Ohio Pediatric Research Assn.
  • Toledo Institute of Clinical Research
  • Great Lakes Medical Research, LLC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Device: CREON2000A

Device: Sham Comparator

Arm Description

Children with mild to moderate asthma maintains allergy medicines have an experimental ultra violet device installed in their homes.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in Forced Expiratory Volume (FEV1)
• in the mean change in FEV1 (% predicted) from Baseline (Visit 1) to 12-month follow up office visit
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
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
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
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
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.
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

Full Information

First Posted
March 10, 2016
Last Updated
October 30, 2020
Sponsor
General Innovations and Goods, Inc.
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID), University of Cincinnati, Bernstein Clinical Research Center
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1. Study Identification

Unique Protocol Identification Number
NCT02715375
Brief Title
Investigate the Effect of the CREON2000A on Asthma Control in Children With Mild to Moderate Persistent Asthma
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
March 10, 2016 (Actual)
Primary Completion Date
October 15, 2020 (Actual)
Study Completion Date
October 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
General Innovations and Goods, Inc.
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID), University of Cincinnati, Bernstein Clinical Research Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
asthma environment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
83 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Device: CREON2000A
Arm Type
Experimental
Arm Description
Children with mild to moderate asthma maintains allergy medicines have an experimental ultra violet device installed in their homes.
Arm Title
Device: Sham Comparator
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
CREON2000A
Primary Outcome Measure Information:
Title
Change in CASI Score
Description
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
Time Frame
Baseline and 12 months
Secondary Outcome Measure Information:
Title
Change in Forced Expiratory Volume (FEV1)
Description
• in the mean change in FEV1 (% predicted) from Baseline (Visit 1) to 12-month follow up office visit
Time Frame
Baseline and 12 months
Title
Mean change in number of day time symptom scores
Description
• 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
Time Frame
Baseline, 4, 8 and12 months
Title
Mean change in number of night time symptoms
Description
• 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
Time Frame
Baseline, 4, 8 and 12 months
Title
Mean change in the number of daily puffs/inhalations of short-acting beta-agonist (SABA) rescue medication
Description
• 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
Time Frame
Baseline, 4, 8 and 12 months
Title
Mean Change in CASI
Description
• in the mean change in CASI from Baseline (Visit 1) to 4- and 8- and 12-month follow up office visits
Time Frame
Baseline, 4, 8 and 12 months
Title
Mean change in daily does of inhaled glucocorticoids taken (µg/day)
Description
• 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.
Time Frame
Baseline 4, 8 and 12 months
Title
Mean change in the percentage of patients with an asthma exacerbation
Description
• 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
Time Frame
Baseline and12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria Males and Females ages 6.0 to 17.0 years. Subjects with a physician diagnosis of mild or moderate persistent asthma. FEV1 ≥ 60% predicted with ≥ 12% improvement after bronchodilator therapy. 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 Current smokers Passive exposure to environmental tobacco smoke at home or active fireplaces and other sources of air particulates (wood burning stoves, kerosene heaters) at home. Diagnosed by a physician with a chronic lung disease other than asthma. Upper or lower respiratory infection within four weeks prior to enrollment. Known to have any other chronic illness (besides asthma) that is not well controlled at the time of screening (Visit 1). 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). Participation in another investigational drug/device study within the past 3 months (not including chart or observational studies)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Bernstein, MD
Organizational Affiliation
University of Cincinnati, Cincinnati, Ohio
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mark Glazman, PhD
Organizational Affiliation
General Innovations and Goods, Inc. (GI&G)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Advanced Research Institute of Miami, LLC
City
Homestead
State/Province
Florida
ZIP/Postal Code
33030
Country
United States
Facility Name
Allergy & Asthma Associates
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Facility Name
Cincinnati Childrens Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
Bernstein Clinical Research Center, LLC
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45231
Country
United States
Facility Name
Columbus Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Facility Name
Ohio Pediatric Research Assn.
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45414
Country
United States
Facility Name
Toledo Institute of Clinical Research
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43560
Country
United States
Facility Name
Great Lakes Medical Research, LLC
City
Willoughby
State/Province
Ohio
ZIP/Postal Code
44094
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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