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

Asthma Clinical Trial

— SICAS-2  

Official title:

School Inner-City Asthma Intervention Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02291302
• Other study ID #: U01AI110397
• Secondary ID: U01AI110397
• Status: Completed
• Phase: N/A
• Start date: January 2015
• Est. completion date: June 2020

Study information

• Verified date: July 2021
• Source: Boston Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 236
• Est. completion date: June 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 15 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• moving schools

Related Conditions & MeSH terms

• Asthma

Intervention

Other:
• integrated pest management
integrated pest management and environmental strategy
• air purifier
air purifiers
• No intervention (control)
no integrated pest management and sham air purifier

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts

Sponsors (4)

Lead Sponsor	Collaborator
Boston Children's Hospital	Harvard School of Public Health, National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Lung Function	Spirometry measure of forced expiration volume in 1 second	12 months
Other	School Absences	Number of school days missed because of asthma/ 2 weeks	12 months
Other	Composite Asthma Severity Index	[a comprehensive severity scale of day symptoms and albuterol use, night symptoms and albuterol use, controller treatment, lung function measures, and exacerbations], health care utilization, and pulmonary function testing (PFT's) including FEV1; FEV1/FVC, FEF25-75. CASI ranges from 0 (lowest) -20 points (highest) with a minimal clinically important difference of 0.49 points. The higher score is worse outcome.	12 months
Primary	Maximum Number of Days With Asthma Symptoms Within 2 Weeks	Maximum number of; Days with wheezing, tightness in the chest, or cough and/or; Nights with disturbed sleep as a result of asthma and/or; Days on which the child had to slow down or discontinue play activities because of asthma This is defined as a cumulative assessment from the different variables listed in the Measure Description	up to 12 months