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Completed

NCT Number: NCT02291302

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

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

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

4 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • moving schools

Treatment and study plan

integrated pest management

Other

integrated pest management and environmental strategy

Air purifier

Other

air purifiers

No intervention (control)

Other

no integrated pest management and sham air purifier

Primary outcomes

  1. Maximum Number of Days With Asthma Symptoms Within 2 Weeks

    Time frame: up to 12 months

    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

Other outcomes

  1. Lung Function

    Time frame: 12 months

    Spirometry measure of forced expiration volume in 1 second

  2. School Absences

    Time frame: 12 months

    Number of school days missed because of asthma/ 2 weeks

  3. 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.

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Collaborators

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

Registry information

Official study title

School Inner-City Asthma Intervention Study

Acronym: SICAS-2

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Nov 14, 2014
Registry last updated
Jan 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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