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

NCT ID: NCT02715375

Last Updated: 2020-11-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 83 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-10
• Study Completion Date: 2020-10-15

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.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Device: CREON2000A

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

Group Type: EXPERIMENTAL

CREON2000A

Intervention Type: DEVICE

Device: Sham Comparator

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.

Group Type: SHAM_COMPARATOR

CREON2000A

Intervention Type: DEVICE

Interventions

CREON2000A

Intervention Type: DEVICE

Eligibility 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)

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: collaborator

University of Cincinnati

OTHER

Sponsor Role: collaborator

Bernstein Clinical Research Center

OTHER

Sponsor Role: collaborator

General Innovations and Goods, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jonathan Bernstein, MD

Role: STUDY_CHAIR

University of Cincinnati, Cincinnati, Ohio

Mark Glazman, PhD

Role: PRINCIPAL_INVESTIGATOR

General Innovations and Goods, Inc. (GI&G)

Locations

Advanced Research Institute of Miami, LLC

Homestead, Florida, United States

Allergy & Asthma Associates

Lexington, Kentucky, United States

Cincinnati Childrens Hospital Medical Center

Cincinnati, Ohio, United States

Bernstein Clinical Research Center, LLC

Cincinnati, Ohio, United States

Columbus Nationwide Children's Hospital

Columbus, 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

Countries

United States

References

Bernstein JA, Seth A, Rao M, Katz JC, Singh U, Greisner W, Lierl M, Prince B, Mavunda K, Bernstein CK, Guan T, Nation AJ, Rudman Spergel AK, Togias A, Glazman M. Randomized trial of ultraviolet irradiation units installed in homes of children and adolescents with asthma. J Allergy Clin Immunol Glob. 2025 Jan 29;4(2):100427. doi: 10.1016/j.jacig.2025.100427. eCollection 2025 May.

Reference Type: DERIVED

PMID: 40091880 (View on PubMed)

Other Identifiers

U44AI074918

Identifier Type: NIH

Identifier Source: secondary_id

View Link

U44-CRE-01

Identifier Type: -

Identifier Source: org_study_id