Childhood Asthma Reduction Study

Asthma is the most prevalent chronic childhood condition and is the most frequent cause of
hospitalization among children. There are about 6.7 million children in the U.S. who
currently have asthma, and nearly two of every three of these children had at least one
attack in the past 12 months. Evidence suggests that exposure to cockroach allergen might be
the most important risk factor for asthma in inner-city households. An environmental
intervention targeting only cockroach allergen could potentially provide cost savings in a
public health program over high cost multi-component interventions, if it could be shown to
reduce asthma morbidity.

The primary objective of the Childhood Asthma REduction Study (CARES) is to evaluate the
effectiveness of a novel cockroach eradication method, shown in prior studies to drastically
decrease cockroach allergen levels, in reducing asthma morbidity in children with moderate
to severe asthma who are both allergic and exposed to cockroach allergen. Additionally, the
study will characterize relationships between cockroach infestation and other environmental
allergen exposures, and asthma morbidity, as well as consider dynamic relationships between
cockroach counts and observed allergen reductions over time; and use study data to identify
mechanisms such as cleaning behaviors that may influence those relationships.

These objectives will be addressed through a prospective, randomized controlled, multi-site
intervention trial in which 414 eligible children age 5 to 14 years who live in households
with a confirmed trap count of 30 or more cockroaches over a 3-day period, are randomly
assigned to one of two treatment groups. Treatment will be implemented at multiple intervals
in the homes of children assigned to the intervention group. Children in both the
intervention and control groups will receive clinical evaluations for asthma, home
assessments of allergen exposures, educational materials on allergen exposures and asthma,
and information on study results. Following 12-months of active data collection, the
extermination treatment will be made available to the homes of children in the control
group. The target sample size is 372 participants completing the study, equally divided into
the two arms. Home environmental assessments following the enrollment visit will take place
at enrollment, 1, 3, 6, 9, and 12 months. Clinical assessments will also be conducted in the
home at enrollment and the 12-month visit. Primary outcome data will be collected during
scheduled follow up phone calls every two months.

- INCLUSION CRITERIA:

A child will be included in this study if the following criteria apply:

(Assessed during phone screening)

- Aged 5 to 14 years of age

- Physician diagnosis of asthma for at least one year prior to prescreening

- Parent/guardian able and willing to provide consent; child able and willing to
provide assent

- Primary caretaker and child are able to speak English or Spanish

- Moderate to severe asthma as defined by the child experiencing one of the following:

- One overnight hospitalization for asthma within the past 6 months,

OR

--Two unscheduled clinic or emergency department visits for asthma within the past 12
months

-Sleeps in the target home greater than or equal to 5 nights per week

(Assessed at beginning of enrollment/baseline visit)

- Target home has greater than or equal to 30 cockroaches trapped in a 3 day period

- Positive ImmunoCAP(Registered Trademark) Rapid test result to cockroach allergen

EXCLUSION CRITERIA:

A child will be excluded from this study if the following criteria apply, as determined in
the screening phone call and/or confirmed at the baseline visit:

- The child has other serious medical or chronic illnesses, other than asthma, such as:

- Any hematologic, metabolic/endocrine, respiratory (other than asthma), cardiac
or neurologic disorder requiring daily medications;

- Any severe behavioral problem that prohibits the child or the child's caregiver
from answering questions or following instructions;

- Any autoimmune disease including rheumatoid arthritis, lupus, and myositis;

- Any immune deficiency;

- Any other serious medical condition such as juvenile diabetes mellitus,
hypothyroidism, hyperthyroidism, cerebral palsy, hyperimmunoglobulin E syndrome,
or diagnosed allergic bronchopulmonary aspergillosis.

- Plans to move within the 12 months of study enrollment

- Has no caregiver with access to a phone

Sibling or other household member currently participating in the study.