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

NCT02715375 | Completed DMC

• 2 other identifiers: U44-CRE-01U44AI074918
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 8

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.

Conditions

Asthma

Keywords

asthma environment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Change in Forced Expiratory Volume (FEV1)

  Baseline and 12 months

• Mean change in number of day time symptom scores

  Baseline, 4, 8 and12 months

• Mean change in number of night time symptoms

  Baseline, 4, 8 and 12 months

• Mean change in the number of daily puffs/inhalations of short-acting beta-agonist (SABA) rescue medication

  Baseline, 4, 8 and 12 months

• Mean Change in CASI

  Baseline, 4, 8 and 12 months

Study Arms (2)

Device: CREON2000A

EXPERIMENTAL

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

Device: CREON2000A

Device: Sham Comparator

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.

Device: CREON2000A

Interventions

CREON2000A DEVICE

Device: CREON2000A; Device: Sham Comparator

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• General Innovations and Goods, Inc.: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• University of Cincinnati: collaborator
• Bernstein Clinical Research Center: collaborator

Study Sites (8)

Advanced Research Institute of Miami, LLC

Homestead, Florida, 33030, United States

Location

Allergy & Asthma Associates

Lexington, Kentucky, 40509, United States

Location

Cincinnati Childrens Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Bernstein Clinical Research Center, LLC

Cincinnati, Ohio, 45231, United States

Location

Columbus Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Ohio Pediatric Research Assn.

Dayton, Ohio, 45414, United States

Location

Toledo Institute of Clinical Research

Toledo, Ohio, 43560, United States

Location

Great Lakes Medical Research, LLC

Willoughby, Ohio, 44094, United States

Location

Related Publications (1)

• 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.

  PMID: 40091880 DERIVED

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Jonathan Bernstein, MD

  University of Cincinnati, Cincinnati, Ohio

  STUDY CHAIR

• Mark Glazman, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2016
• First Posted: March 22, 2016
• Study Start: March 10, 2016
• Primary Completion: October 15, 2020
• Study Completion: October 15, 2020
• Last Updated: November 3, 2020

Record last verified: 2020-10

Locations

US (8)