School Inner-City Asthma Intervention Study (SICAS-2)

Boston Children's Hospital

Status: Completed

Conditions: Asthma

Treatments: Other: integrated pest management; Other: No intervention (control); Other: air purifier

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02291302

U01AI110397 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The investigators goal is to determine the efficacy of school/classroom based environmental intervention in reducing asthma morbidity in urban schoolchildren.

Full description

Our proposal builds upon our established, successful school-based infrastructure to determine whether a school/classroom intervention will efficiently and effectively improve asthma morbidity by reducing these exposures. Our goal is to determine the efficacy of school/classroom based environmental intervention in reducing asthma morbidity in urban schoolchildren. Our central hypothesis is that reducing classroom/school exposure to mouse allergen, mold, and particulate pollutants will decrease asthma morbidity in students with asthma. The investigators plan to test this hypothesis in an intervention study of 300 elementary students with asthma from multiple classrooms in inner-city elementary schools. Our clinical trial aims are to determine the effectiveness of a school/classroom based environmental intervention (school integrated pest management and classroom air purifying filter units within these schools) to reduce asthma morbidity. Our mechanistic aim is to test the hypothesis that effects of school/classroom-based environmental interventions on symptoms/other measures of asthma control occur through changes in gene methylation or expression in pathways (and secondarily, in genes) relevant to airway function and asthma. This will expand our understanding of asthma immunopathogenesis and create opportunities to identify potential novel targets for asthma therapy.

Enrollment: 236 patients

Sex: All

Ages: 4 to 15 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• grades K-8 with asthma attending sampling/intervention schools

Exclusion criteria

• moving schools

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

---

236 participants in 4 patient groups, including a placebo group

Environmental Intervention

Active Comparator group

Description:

Active Classroom air purifiers and school integrated pest management environmental intervention

Treatment:

Other: air purifier

Other: integrated pest management

Sham and Control (control)

Placebo Comparator group

Description:

Sham air purifiers and no school integrated pest management environmental intervention

Treatment:

Other: No intervention (control)

Active Air Purifier and Control

Placebo Comparator group

Description:

Active air purifiers and no school integrated pest management environmental intervention

Treatment:

Other: air purifier

Sham and Inegrated Pest

Sham Comparator group

Description:

Sham air purifiers and active school integrated pest management

Treatment:

Other: integrated pest management