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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02291302
Recruitment Status : Completed
First Posted : November 14, 2014
Results First Posted : September 23, 2020
Last Update Posted : August 13, 2021
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
Harvard School of Public Health (HSPH)
Information provided by (Responsible Party):
Wanda Phipatanakul, Boston Children's Hospital

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

Condition or disease Intervention/treatment Phase
Asthma Other: integrated pest management Other: air purifier Other: No intervention (control) Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 236 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: School Inner-City Asthma Intervention Study
Actual Study Start Date : January 2015
Actual Primary Completion Date : June 2020
Actual Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Other Outcome Measures:
  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.


Eligibility Criteria
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Ages Eligible for Study:   4 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • moving schools
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02291302


Locations
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United States, Massachusetts
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Boston Children's Hospital
National Institutes of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
Harvard School of Public Health (HSPH)
Investigators
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Principal Investigator: Wanda Phipatanakul, MD, MS Boston Children's Hospital
  Study Documents (Full-Text)

Documents provided by Wanda Phipatanakul, Boston Children's Hospital:
Study Protocol and Statistical Analysis Plan  [PDF] March 27, 2015

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Wanda Phipatanakul, Professor of Pediatrics, Boston Children's Hospital
ClinicalTrials.gov Identifier: NCT02291302    
Other Study ID Numbers: U01AI110397 ( U.S. NIH Grant/Contract )
U01AI110397 ( U.S. NIH Grant/Contract )
First Posted: November 14, 2014    Key Record Dates
Results First Posted: September 23, 2020
Last Update Posted: August 13, 2021
Last Verified: July 2021
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
 Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases