Environmental Intervention to Reduce Allergens in Urban Schools and Childhood Asthma

June 5, 2022 updated by: Wanda Phipatanakul, Boston Children's Hospital
The investigators aim to pilot the role of school based intervention consisting of enhanced integrated pest management, classroom air purifiers and cleaning improves asthma morbidity.

Study Overview

Detailed Description

By piloting this school based intervention, the investigators hope to learn from this study the best way to design and implement more cost and time efficient large-based school-based environmental interventions that may potentially help a community of children with asthma, allergic diseases, and its associated morbidity.

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Boston Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 15 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • moving schools

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Environmental Intervention
4 classroom air purifiers and school integrated pest management environmental intervention
integrated pest management and environmental strategy
air purifiers
Placebo Comparator: Sham and Control
4 sham air purifiers and no school integrated pest management environmental intervention
sham air purifiers
Placebo Comparator: Active Air Purifier and Control
4 air purifiers and no school integrated pest management environmental intervention
air purifiers
Sham Comparator: Sham and Integrated Pest Management
4 classroom sham air purifiers and school integrated pest management
integrated pest management and environmental strategy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Asthma Symptoms
Time Frame: over a two week period at Baseline and Months 3, 6, 9 and 12
number of days of wheezing/cough
over a two week period at Baseline and Months 3, 6, 9 and 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lung Function
Time Frame: measured at baseline and months 6 and 12
peak expiratory flow (PEF)
measured at baseline and months 6 and 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

May 21, 2013

First Submitted That Met QC Criteria

July 29, 2013

First Posted (Estimate)

August 1, 2013

Study Record Updates

Last Update Posted (Actual)

June 7, 2022

Last Update Submitted That Met QC Criteria

June 5, 2022

Last Verified

June 1, 2022

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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