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

Primary Purpose

Asthma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
integrated pest management
air purifier
No intervention (control)
Sponsored by
Boston Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

4 Years - 15 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • moving schools

Sites / Locations

  • Boston Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

Placebo Comparator

Sham Comparator

Arm Label

Environmental Intervention

Sham and Control (control)

Active Air Purifier and Control

Sham and Inegrated Pest

Arm Description

Active Classroom air purifiers and school integrated pest management environmental intervention

Sham air purifiers and no school integrated pest management environmental intervention

Active air purifiers and no school integrated pest management environmental intervention

Sham air purifiers and active school integrated pest management

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
November 7, 2014
Last Updated
July 21, 2021
Sponsor
Boston Children's Hospital
Collaborators
National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID), Harvard School of Public Health (HSPH)
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1. Study Identification

Unique Protocol Identification Number
NCT02291302
Brief Title
School Inner-City Asthma Intervention Study (SICAS-2)
Acronym
SICAS-2
Official Title
School Inner-City Asthma Intervention Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
January 2015 (Actual)
Primary Completion Date
June 2020 (Actual)
Study Completion Date
June 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Children's Hospital
Collaborators
National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID), Harvard School of Public Health (HSPH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
236 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Environmental Intervention
Arm Type
Active Comparator
Arm Description
Active Classroom air purifiers and school integrated pest management environmental intervention
Arm Title
Sham and Control (control)
Arm Type
Placebo Comparator
Arm Description
Sham air purifiers and no school integrated pest management environmental intervention
Arm Title
Active Air Purifier and Control
Arm Type
Placebo Comparator
Arm Description
Active air purifiers and no school integrated pest management environmental intervention
Arm Title
Sham and Inegrated Pest
Arm Type
Sham Comparator
Arm Description
Sham air purifiers and active school integrated pest management
Intervention Type
Other
Intervention Name(s)
integrated pest management
Intervention Description
integrated pest management and environmental strategy
Intervention Type
Other
Intervention Name(s)
air purifier
Intervention Description
air purifiers
Intervention Type
Other
Intervention Name(s)
No intervention (control)
Intervention Description
no integrated pest management and sham air purifier
Primary Outcome Measure Information:
Title
Maximum Number of Days With Asthma Symptoms Within 2 Weeks
Description
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
Time Frame
up to 12 months
Other Pre-specified Outcome Measures:
Title
Lung Function
Description
Spirometry measure of forced expiration volume in 1 second
Time Frame
12 months
Title
School Absences
Description
Number of school days missed because of asthma/ 2 weeks
Time Frame
12 months
Title
Composite Asthma Severity Index
Description
[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.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: grades K-8 with asthma attending sampling/intervention schools Exclusion Criteria: moving schools
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wanda Phipatanakul, MD, MS
Organizational Affiliation
Boston Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
35688366
Citation
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.
Results Reference
derived
PubMed Identifier
34547084
Citation
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.
Results Reference
derived
PubMed Identifier
29673798
Citation
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.
Results Reference
derived

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

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