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

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ClinicalTrials.gov Identifier: NCT02715375
Recruitment Status : Completed
First Posted : March 22, 2016
Last Update Posted : February 26, 2020
Sponsor:
Collaborators:
National Institute of Allergy and Infectious Diseases (NIAID)
University of Cincinnati
Bernstein Clinical Research Center
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Asthma Device: CREON2000A Device: Sham Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 83 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : March 10, 2016
Actual Primary Completion Date : May 18, 2019
Actual Study Completion Date : May 18, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: Device: CREON2000A
Child with mild to moderate asthma maintains allergy medicines and has experimental device installed in home. Will child's use of asthma medicine decrease more than the child who lives with the Device: Sham CREON2000A?
Device: CREON2000A
Sham Comparator: Device: Sham CREON2000A
Child with mild to moderate asthma maintains allergy medicines and has sham installed in home. What impact will the Device: Sham CREON2000A have and will the child's medical use parallel that of the child with the experimental Device: CREON2000A?
Device: Sham



Primary Outcome Measures :
  1. Change in CASI Score [ Time Frame: 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 :
  1. Change in Forced Expiratory Volume (FEV1) [ Time Frame: Baseline and 12 months ]
    • in the mean change in FEV1 (% predicted) from Baseline (Visit 1) to 12-month follow up office visit

  2. Mean change in number of day time symptom scores [ Time Frame: 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

  3. Mean change in number of night time symptoms [ Time Frame: 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

  4. Mean change in the number of daily puffs/inhalations of short-acting beta-agonist (SABA) rescue medication [ Time Frame: 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

  5. Mean Change in CASI [ Time Frame: 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

  6. Mean change in daily does of inhaled glucocorticoids taken (µg/day) [ Time Frame: 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.

  7. Mean change in the percentage of patients with an asthma exacerbation [ Time Frame: 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



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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02715375


Locations
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United States, Florida
Advanced Research Institute of Miami, LLC
Homestead, Florida, United States, 33030
United States, Kentucky
Allergy & Asthma Associates
Lexington, Kentucky, United States, 40509
United States, Ohio
Cincinnati Childrens Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Bernstein Clinical Research Center, LLC
Cincinnati, Ohio, United States, 45231
Columbus Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Ohio Pediatric Research Assn.
Dayton, Ohio, United States, 45414
Toledo Institute of Clinical Research
Toledo, Ohio, United States, 43560
Great Lakes Medical Research, LLC
Willoughby, Ohio, United States, 44094
Sponsors and Collaborators
General Innovations and Goods, Inc.
National Institute of Allergy and Infectious Diseases (NIAID)
University of Cincinnati
Bernstein Clinical Research Center
Investigators
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Study Chair: Jonathan Bernstein, MD University of Cincinnati, Cincinnati, Ohio
Principal Investigator: Mark Glazman, PhD General Innovations and Goods, Inc. (GI&G)
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Responsible Party: General Innovations and Goods, Inc.
ClinicalTrials.gov Identifier: NCT02715375    
Other Study ID Numbers: U44-CRE-01
U44AI074918 ( U.S. NIH Grant/Contract )
First Posted: March 22, 2016    Key Record Dates
Last Update Posted: February 26, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by General Innovations and Goods, Inc.:
asthma environment
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases