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

December 18, 2024 updated by: Wanda Phipatanakul, Boston Children's Hospital

School Inner-City Asthma Intervention Study

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

236

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Boston Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 15 years (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • moving schools

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Environmental Intervention
Active Classroom air purifiers and school integrated pest management environmental intervention
Other: integrated pest management
integrated pest management and environmental strategy
Other: air purifier
air purifiers
Placebo Comparator: Sham and Control (control)
Sham air purifiers and no school integrated pest management environmental intervention
Other: No intervention (control)
no integrated pest management and sham air purifier
Placebo Comparator: Active Air Purifier and Control
Active air purifiers and no school integrated pest management environmental intervention
Other: air purifier
air purifiers
Sham Comparator: Sham and Inegrated Pest
Sham air purifiers and active school integrated pest management
Other: integrated pest management
integrated pest management and environmental strategy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum Number of Days With Asthma Symptoms Within 2 Weeks
Time Frame: up to 12 months

Maximum number of

  1. Days with wheezing, tightness in the chest, or cough and/or
  2. Nights with disturbed sleep as a result of asthma and/or
  3. 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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lung Function
Time Frame: 12 months
Spirometry measure of forced expiration volume in 1 second
12 months
School Absences
Time Frame: 12 months
Number of school days missed because of asthma/ 2 weeks
12 months
Composite Asthma Severity Index
Time Frame: 12 months
[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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Children's Hospital

Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)
National Institutes of Health (NIH)
Harvard School of Public Health (HSPH)

Investigators

  • Principal Investigator: Wanda Phipatanakul, MD, MS, Boston Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Actual)

June 1, 2020

Study Completion (Actual)

June 1, 2020

Study Registration Dates

First Submitted

November 7, 2014

First Submitted That Met QC Criteria

November 13, 2014

First Posted (Estimated)

November 14, 2014

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 18, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U01AI110397 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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