Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2025 Jan 29;4(2):100427.
doi: 10.1016/j.jacig.2025.100427. eCollection 2025 May.

Randomized trial of ultraviolet irradiation units installed in homes of children and adolescents with asthma

Jonathan A Bernstein  1   2 , Anand Seth  3 , Marepalli Rao  4 , Janyce C Katz  3 , Umesh Singh  1 , William Greisner  5 , Michelle Lierl  6 , Benjamin Prince  7 , Kunjana Mavunda  8 , Cheryl K Bernstein  2 , Tianyuan Guan  9 , Amy J Nation  10 , Amanda K Rudman Spergel  11 , Alkis Togias  11 , Mark Glazman  3
Affiliations

Randomized trial of ultraviolet irradiation units installed in homes of children and adolescents with asthma

Jonathan A Bernstein et al. J Allergy Clin Immunol Glob. .

Abstract

Background: Asthma management involves medications with environmental control, but patient adherence to the latter is poor. A previous pilot study found an ultraviolet indoor air-irradiation system (CREON2000A) was effective in reducing asthma severity in children with mild to moderate asthma.

Objective: This trial's purpose was to confirm these results in a larger population over a longer time duration.

Methods: A 12-month randomized, sham device-controlled multicenter study enrolled 79 children with mild to moderate persistent asthma aged 6 to <18 years. Participants were randomized to have a CREON2000A ultraviolet air irradiation device or a sham device installed in their home's ventilation system. Enrolled children were assessed with the Composite Asthma Severity Index at baseline and every 4 months; asthma treatment was adjusted according to National Heart, Lung, and Blood Institute EPR-3 guidelines. The primary analysis compared the efficacy of the CREON2000A versus sham device from baseline to end of study (12-month visit). A sensitivity analysis compared efficacy across the 4-, 8-, and 12-month visits.

Trial registration: Investigate the Effect of the CREON2000A on Asthma Control in Children With Mild to Moderate Persistent Asthma (CREON2000A), ClinicalTrials.gov, NCT02715375.

Results: Baseline demographic characteristics of CREON2000A (n = 40) versus sham device (n = 39) groups were similar. The primary analysis estimated a difference in Composite Asthma Severity Index score for CREON2000A at 12 months relative to the sham device, which was not statistically significant (ΔEstimated = 0.53; P = .404; 95% confidence interval, -0.576, 1.628). A sensitivity analysis detected a device benefit across all postbaseline values (ΔEstimated = 0.76; P = .034; 95% confidence interval, 0.057, 1.465). A benefit was also observed for asthma daytime symptom score, average asthma exacerbations score, missed school days, rhinitis symptoms, and average number of respiratory infections (nominal P < .05 in all cases).

Conclusion: This small trial is inconclusive, but some results show promise, suggesting that this device and the concept of indoor air irradiation as an environmental intervention is worthy of further study in children with mild to moderate persistent asthma.

Keywords: Asthma; CASI; CREON2000A; environmental intervention; ultraviolet.

PubMed Disclaimer

Conflict of interest statement

Funded by the 10.13039/100000060National Institute of Allergy and Infectious Diseases (NIAID)/National Institutes of Health (NIH) through grant U44 AI095051 awarded to General Innovations and Goods Inc (GI&G) via a SBIR U44 award. GI&G was the sponsor of the trial. In accordance with the nature of the NIAID/NIH funding (a cooperative agreement grant), NIAID staff had substantial involvement in the study. The authorship of A.K.R.S. and A.T. does not necessarily represent the opinions of NIAID/NIH or any other agency of the United States government. Disclosure of potential conflict of interest: J. A. Bernstein reports acting as PI for GI&G; PI or sub-PI and consultant for ALK, Allergy Therapeutics, Amgen, Areteia Therapeutics, AstraZeneca, Boehringer Ingelheim, Genentech, GSK, Merck, Novartis, Sanofi-Regeneron, and TEVA; is immediate past president of the American Academy of Allergy, Asthma & Immunology (AAAAI); is Chairperson of the AAAAI Foundation; is a Joint Task Force member; is a GINA Guideline Advocate; and is on the board of directors of WAO and Interasma. A. Seth, J. C. Katz, and M. Glazman are employees of GI&G, the study’s sponsor. The rest of the authors declare that they have no relevant conflicts of interest.

Figures

Fig 1
Fig 1
CONSORT (Consolidated Standards of Reporting Trials) diagram showing study enrollment, randomization, and allocation of subjects.
Fig 2
Fig 2
CASI scores over time. Average CASI score at each study visit by intervention arm (sensitivity analysis). Mean asthma severity (CASI) scores over 12 months are also summarized.
See this image and copyright information in PMC

References

    1. Akinbami L.J., Moorman J.E., Garbe P.L., Sondik E.J. Status of childhood asthma in the United States, 1980-2007. Pediatrics. 2009;123(suppl 3):S131–S145. - PubMed
    1. US Centers for Disease Control and Prevention AsthmaStats. https://www.cdc.gov/asthma/asthma_stats/default.htm Last reviewed July 24, 2023. Available at:
    1. Pearce N., Ait-Khaled N., Beasley R., Mallol J., Keil U., Mitchell E., et al. Worldwide trends in the prevalence of asthma symptoms: phase III of the International Study of Asthma and Allergies in Childhood (ISAAC) Thorax. 2007;62:758–766. - PMC - PubMed
    1. Pijnenburg M.W., Fleming L. Advances in understanding and reducing the burden of severe asthma in children. Lancet Respir Med. 2020;8:1032–1044. - PubMed
    1. Hsu J., Qin X., Beavers S.F., Mirabelli M.C. Asthma-related school absenteeism, morbidity, and modifiable factors. Am J Prev Med. 2016;51:23–32. - PMC - PubMed

Associated data

LinkOut - more resources