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

NCT02291302 | Completed Results DMC

• 1 other identifier: U01AI110397
• Study Type: interventional
• Target: 236
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• Maximum Number of Days With Asthma Symptoms Within 2 Weeks

  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 Outcomes (3)

• Lung Function

  12 months

• School Absences

  12 months

• Composite Asthma Severity Index

  12 months

Study Arms (4)

Environmental Intervention

ACTIVE COMPARATOR

Active Classroom air purifiers and school integrated pest management environmental intervention

Other: integrated pest management; Other: air purifier

Sham and Control (control)

PLACEBO COMPARATOR

Sham air purifiers and no school integrated pest management environmental intervention

Other: No intervention (control)

Active Air Purifier and Control

PLACEBO COMPARATOR

Active air purifiers and no school integrated pest management environmental intervention

Other: air purifier

Sham and Inegrated Pest

SHAM COMPARATOR

Sham air purifiers and active school integrated pest management

Other: integrated pest management

Interventions

integrated pest management OTHER

integrated pest management and environmental strategy

Environmental Intervention; Sham and Inegrated Pest

air purifier OTHER

air purifiers

Active Air Purifier and Control; Environmental Intervention

No intervention (control) OTHER

no integrated pest management and sham air purifier

Sham and Control (control)

Eligibility Criteria

• Age: 4 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• moving schools

Sponsors & Collaborators

• Boston Children's Hospital: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• Harvard School of Public Health (HSPH): collaborator

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (3)

• 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.

  PMID: 35688366 DERIVED

• 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.

  PMID: 34547084 DERIVED

• 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.

  PMID: 29673798 DERIVED

MeSH Terms

Conditions

Asthma

Interventions

Air Filters

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Filtration; Chemistry Techniques, Analytical; Investigative Techniques; Equipment and Supplies

Results Point of Contact

• Title: Wanda Phipatanakul, MD. MS.
• Organization: Boston Children's Hospital

wanda.phipatanakul@childrens.harvard.edu

617-355-6117

Study Officials

• Wanda Phipatanakul, MD, MS

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

Study Record Dates

• First Submitted: November 7, 2014
• First Posted: November 14, 2014
• Study Start: January 1, 2015
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: January 7, 2025
• Results First Posted: September 23, 2020

Record last verified: 2024-12

Locations

US (1)