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

This study has been completed.
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Wanda Phipatanakul, Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT01756391
First received: December 20, 2012
Last updated: December 4, 2014
Last verified: December 2014
  Purpose
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.

Condition
Asthma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Allergens in Inner-City Schools and Childhood Asthma

Further study details as provided by Boston Children’s Hospital:

Primary Outcome Measures:
  • Maximum Symptom Days/14 Days [ Time Frame: 14 days ] [ Designated as safety issue: No ]

    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



Secondary Outcome Measures:
  • Days of Slowed Activity Due to Asthma [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Days of Exercise-induced Symptoms [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Days of Cough Without an Upper Respiratory Infection [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Nights of Wakening Due to Asthma Symptoms [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Number of Hospitalizations [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Emergency Department Visits [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Unscheduled Physician/Health Care Visits [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Prednisone Bursts [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • FEV1/FVC [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • FEV1 Percent Predicted [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Percent Change in FEV1 After Short-acting Beta Agonist [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Exhaled Nitric Oxide Levels [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 351
Study Start Date: March 2008
Study Completion Date: October 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   4 Years to 15 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
elementary school students with asthma
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01756391

Locations
United States, Massachusetts
Children's Hospital, Boston
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Boston Children’s Hospital
National Institutes of Health (NIH)
  More Information

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Wanda Phipatanakul, Associate Professor of Pediatrics, Children's Hospital Boston
ClinicalTrials.gov Identifier: NCT01756391     History of Changes
Other Study ID Numbers: R01 AI 0739654 
Study First Received: December 20, 2012
Results First Received: November 22, 2014
Last Updated: December 4, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Boston Children’s Hospital:
pediatric
childhood
allergy

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on August 25, 2016