Clinical trial NCT02715375: Investigate the Effect of the CREON2000A on Asthma Control in Children With Mild to Moderate Persistent Asthma
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: asthma environment
Lead sponsor: General Innovations and Goods, Inc.
Sponsor class: INDUSTRY
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
name: University of Cincinnati
name: Bernstein Clinical Research Center
First posted: 2016-03-22
Enrollment: 83
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Change in CASI Score
timeFrame: Baseline and 12 months
Secondary outcomes:
measure: Change in Forced Expiratory Volume (FEV1)
timeFrame: Baseline and 12 months
measure: Mean change in number of day time symptom scores
timeFrame: Baseline, 4, 8 and12 months
measure: Mean change in number of night time symptoms
timeFrame: Baseline, 4, 8 and 12 months
measure: Mean change in the number of daily puffs/inhalations of short-acting beta-agonist (SABA) rescue medication
timeFrame: Baseline, 4, 8 and 12 months
measure: Mean Change in CASI
timeFrame: Baseline, 4, 8 and 12 months
measure: Mean change in daily does of inhaled glucocorticoids taken (µg/day)
timeFrame: Baseline 4, 8 and 12 months
measure: Mean change in the percentage of patients with an asthma exacerbation
timeFrame: Baseline and12 months
Other outcomes:
Locations:
city: Homestead
country: United States
facility: Advanced Research Institute of Miami, LLC
state: Florida
city: Lexington
country: United States
facility: Allergy & Asthma Associates
state: Kentucky
city: Cincinnati
country: United States
facility: Cincinnati Childrens Hospital Medical Center
state: Ohio
city: Cincinnati
country: United States
facility: Bernstein Clinical Research Center, LLC
state: Ohio
city: Columbus
country: United States
facility: Columbus Nationwide Children's Hospital
state: Ohio
city: Dayton
country: United States
facility: Ohio Pediatric Research Assn.
state: Ohio
city: Toledo
country: United States
facility: Toledo Institute of Clinical Research
state: Ohio
city: Willoughby
country: United States
facility: Great Lakes Medical Research, LLC
state: Ohio
Study officials:
affiliation: University of Cincinnati, Cincinnati, Ohio
name: Jonathan Bernstein, MD
role: STUDY_CHAIR
affiliation: General Innovations and Goods, Inc. (GI&G)
name: Mark Glazman, PhD
role: PRINCIPAL_INVESTIGATOR
References: