Asthma Clinical Trial
Official title:
Childhood Asthma Reduction Study
Background:
- Cockroach allergies are an important risk factor for asthma in inner-city households,
especially in children. A new method for killing cockroaches may help children who live in
households that have high numbers of cockroaches. Because most public health treatments
target more than just cockroaches, this method could lower the costs of treating childhood
allergies and asthma by focusing on the most likely source of the allergy.
Objectives:
- To test a new cockroach-killing method designed to reduce asthma in children exposed to
cockroaches.
Eligibility:
- Children 5 to 14 years of age who have moderate to severe asthma.
- Children must live in a household that has a high number of cockroaches.
Design:
- Participants will be screened with a phone call and an initial home visit.
- Study doctors will place cockroach traps, and return after 3 days to check the number of
roaches caught and killed. Dust samples will be collected from the house.
- Participants will have blood and lung function tests, and will be tested for allergies
(including cockroach allergies).
- Some households will be treated for cockroaches at regular intervals, or more frequently
if required by the study doctors.
- Participants will have regular checkup visits in their homes at months 1, 3, 6, 9, and
12 and short phone call interviews at months 2, 4, 6, 8 and 10 to study their asthma
symptoms. The home visits will also check the cockroach levels in the house.
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.
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