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

NCT ID: NCT02291302

Last Updated: 2025-01-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 236 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2020-06-30

Brief Summary

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

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.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Environmental Intervention

Active Classroom air purifiers and school integrated pest management environmental intervention

Group Type: ACTIVE_COMPARATOR

integrated pest management

Intervention Type: OTHER

integrated pest management and environmental strategy

air purifier

Intervention Type: OTHER

air purifiers

Sham and Control (control)

Sham air purifiers and no school integrated pest management environmental intervention

Group Type: PLACEBO_COMPARATOR

No intervention (control)

Intervention Type: OTHER

no integrated pest management and sham air purifier

Active Air Purifier and Control

Active air purifiers and no school integrated pest management environmental intervention

Group Type: PLACEBO_COMPARATOR

air purifier

Intervention Type: OTHER

air purifiers

Sham and Inegrated Pest

Sham air purifiers and active school integrated pest management

Group Type: SHAM_COMPARATOR

integrated pest management

Intervention Type: OTHER

integrated pest management and environmental strategy

Interventions

integrated pest management

integrated pest management and environmental strategy

Intervention Type: OTHER

air purifier

air purifiers

Intervention Type: OTHER

No intervention (control)

no integrated pest management and sham air purifier

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• moving schools

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: collaborator

Harvard School of Public Health (HSPH)

OTHER

Sponsor Role: collaborator

Boston Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Wanda Phipatanakul

Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wanda Phipatanakul, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Locations

Boston Children's Hospital

Boston, Massachusetts, United States

Countries

United States

References

Ruran HB, Maciag MC, Murphy SE, Phipatanakul W, Hauptman M. Cross-sectional study of urinary biomarkers of environmental tobacco and e-cigarette exposure and asthma morbidity. Ann Allergy Asthma Immunol. 2022 Sep;129(3):378-380. doi: 10.1016/j.anai.2022.06.001. Epub 2022 Jun 7. No abstract available.

Reference Type: DERIVED

PMID: 35688366 (View on PubMed)

Phipatanakul W, Koutrakis P, Coull BA, Petty CR, Gaffin JM, Sheehan WJ, Lai PS, Bartnikas LM, Kang CM, Wolfson JM, Samnaliev M, Cunningham A, Baxi SN, Permaul P, Hauptman M, Trivedi M, Louisias M, Liang L, Thorne PS, Metwali N, Adamkiewicz G, Israel E, Baccarelli AA, Gold DR; School Inner-City Asthma Intervention study team. Effect of School Integrated Pest Management or Classroom Air Filter Purifiers on Asthma Symptoms in Students With Active Asthma: A Randomized Clinical Trial. JAMA. 2021 Sep 7;326(9):839-850. doi: 10.1001/jama.2021.11559.

Reference Type: DERIVED

PMID: 34547084 (View on PubMed)

Kantor DB, Petty CR, Phipatanakul W, Gaffin JM. Transcutaneous CO-oximetry differentiates asthma exacerbation and convalescence in children. J Allergy Clin Immunol. 2018 Aug;142(2):676-678.e5. doi: 10.1016/j.jaci.2018.02.048. Epub 2018 Apr 16. No abstract available.

Reference Type: DERIVED

PMID: 29673798 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

U01AI110397

Identifier Type: NIH

Identifier Source: secondary_id

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U01AI110397

Identifier Type: NIH

Identifier Source: org_study_id

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