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

Completed · Not applicable · Has a placebo group

Conditions studied: Asthma

In brief

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.

Key facts

Study ID

NCT02715375

Run by

General Innovations and Goods, Inc.

People needed

83

Starts

2016-03-10

Expected to finish

2020-10-15

Last updated by the study team

2020-11-03

Who can join

Age: 6 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

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)

Where it is running

• Advanced Research Institute of Miami, LLC — Homestead, Florida, United States
• Allergy & Asthma Associates — Lexington, Kentucky, United States
• Cincinnati Childrens Hospital Medical Center — Cincinnati, Ohio, United States
• Bernstein Clinical Research Center, LLC — Cincinnati, Ohio, United States
• Columbus Nationwide Children's Hospital — Columbus, Ohio, United States
• Ohio Pediatric Research Assn. — Dayton, Ohio, United States
• Toledo Institute of Clinical Research — Toledo, Ohio, United States
• Great Lakes Medical Research, LLC — Willoughby, Ohio, United States

Full record on ClinicalTrials.gov

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