Allergens in Inner-City Schools and Childhood Asthma (SICAS-1)

December 4, 2014 updated by: Wanda Phipatanakul, Boston Children's Hospital
Asthma is a disease that affects more than 12% of Americans under the age of 18 for over 14 million missed school days per year, and is the number one cause of school absences in America. Elementary school children spend 6 to 10 hours a day in school, and most of that time is spent in one classroom. The goals of this project are to provide an understanding of exposure risk factors specific to the classroom. This is critical, because the classroom environment could potentially be considered as an effective target for prevention of inner-city asthma morbidity by reducing exposures to many symptomatic children through an intervention in the school classrooms.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

351

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

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

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

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

elementary school students with asthma

Description

Inclusion Criteria:

  • Grades K-8 the school year following spring recruitment (Ages 4-15)
  • Attend one of the schools in the fall where permission obtained for classroom sampling.
  • Able to provide assent and parent/guardian able to provide informed consent Physician-Diagnosed asthma AND Wheezing in the previous 12 months

Exclusion Criteria:

  • Significant pulmonary diseases other than asthma that might influence test results or pose risks (e.g., cystic fibrosis, sarcoidosis, bronchiectasis)
  • Cardiovascular disease that requires daily medication
  • Taking a beta blocker
  • Active smoker
  • Unable to follow through with study visit or complete study procedures

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum Symptom Days/14 Days
Time Frame: 14 days

Largest value among the following:

Number of days with wheezing, tightness in the chest, or cough Number of nights with disturbed sleep as a result of asthma Number of days on which the child had to slow down or discontinue play activities because of asthma
14 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Days of Slowed Activity Due to Asthma
Time Frame: 12 months
12 months
Days of Exercise-induced Symptoms
Time Frame: 12 months
12 months
Days of Cough Without an Upper Respiratory Infection
Time Frame: 12 months
12 months
Nights of Wakening Due to Asthma Symptoms
Time Frame: 12 months
12 months
Number of Hospitalizations
Time Frame: 12 months
12 months
Emergency Department Visits
Time Frame: 12 months
12 months
Unscheduled Physician/Health Care Visits
Time Frame: 12 months
12 months
Prednisone Bursts
Time Frame: 12 months
12 months
FEV1/FVC
Time Frame: 12 months
12 months
FEV1 Percent Predicted
Time Frame: 12 months
12 months
Percent Change in FEV1 After Short-acting Beta Agonist
Time Frame: 12 months
12 months
Exhaled Nitric Oxide Levels
Time Frame: 12 months
12 months

Collaborators and Investigators

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

Sponsor

Boston Children's Hospital

Collaborators

National Institutes of Health (NIH)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

March 1, 2008

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

December 20, 2012

First Submitted That Met QC Criteria

December 20, 2012

First Posted (Estimate)

December 25, 2012

Study Record Updates

Last Update Posted (Estimate)

December 8, 2014

Last Update Submitted That Met QC Criteria

December 4, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01 AI 0739654

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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