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

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.

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)