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AsthmaCREON2000ANCT02715375

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

A study testing CREON2000A in people with Asthma, run by General Innovations and Goods, Inc. at 8 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 6 to 18 years
Conditions the study is for
Asthma
What is being tested?
CREON2000A
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
83 participants
Where
8 sitesUnited States
Study dates
10 Mar 2016to 15 Oct 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

  • 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)

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

United States8 sites

  • Cincinnati Childrens Hospital Medical Center

    Cincinnati, Ohio, 45229

  • Bernstein Clinical Research Center, LLC

    Cincinnati, Ohio, 45231

  • Columbus Nationwide Children's Hospital

    Columbus, Ohio, 43205

  • Ohio Pediatric Research Assn.

    Dayton, Ohio, 45414

  • Advanced Research Institute of Miami, LLC

    Homestead, Florida, 33030

  • Allergy & Asthma Associates

    Lexington, Kentucky, 40509

  • Toledo Institute of Clinical Research

    Toledo, Ohio, 43560

  • Great Lakes Medical Research, LLC

    Willoughby, Ohio, 44094

Other trials in United States

About this study

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

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.

Read the 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
Being tested
CREON2000A
Keywords
asthma environment
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CREON2000ADevice

Study groups in NCT02715375
Study groupRoleWhat they receive
Device: CREON2000AExperimentalChildren with mild to moderate asthma maintains allergy medicines have an experimental ultra violet device installed in their homes.
Receives: Device: CREON2000A
Device: Sham ComparatorSham comparatorChildren 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.
Receives: Device: CREON2000A

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Baseline and 12 months

Secondary outcomes (7)

  1. Change in Forced Expiratory Volume (FEV1)

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

    Measured: Baseline and 12 months

  2. 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

    Measured: Baseline, 4, 8 and12 months

  3. 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

    Measured: Baseline, 4, 8 and 12 months

  4. 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

    Measured: Baseline, 4, 8 and 12 months

  5. 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

    Measured: Baseline, 4, 8 and 12 months

  6. 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.

    Measured: Baseline 4, 8 and 12 months

  7. 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

    Measured: Baseline and12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Mar 2016 (estimated)
  2. Study start10 Mar 2016
  3. Primary completion15 Oct 2020
  4. Study completion15 Oct 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
83 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02715375
Sponsor's protocol ID
U44-CRE-01
Other IDs
U44AI074918
Acronym
CREON2000A
Status last verified
Oct 2020
First submitted
10 Mar 2016
Last updated
3 Nov 2020
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 40091880

Questions about this trial

What is this clinical trial studying?

A study testing CREON2000A in people with Asthma, run by General Innovations and Goods, Inc. at 8 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in CASI Score (time frame: Baseline and 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02715375, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2020.

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