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Completed

NCT Number: NCT02715375

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.

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Key information

Conditions

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

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Advanced Research Institute of Miami, LLC, Homestead, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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)

Treatment and study plan

CREON2000A

Device

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

General Innovations and Goods, Inc.

Industry

Collaborators

  • Bernstein Clinical Research Center
  • National Institute of Allergy and Infectious Diseases (NIAID)
  • University of Cincinnati

Registry information

Official study 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

Acronym: CREON2000A

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Mar 22, 2016
Registry last updated
Nov 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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