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

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. Identifier: NCT01756391
Recruitment Status : Completed
First Posted : December 25, 2012
Results First Posted : December 8, 2014
Last Update Posted : December 8, 2014
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Wanda Phipatanakul, Children's Hospital Boston

Brief Summary:
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 or disease

Study Type : Observational
Actual Enrollment : 351 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Allergens in Inner-City Schools and Childhood Asthma
Study Start Date : March 2008
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. Days of Slowed Activity Due to Asthma [ Time Frame: 12 months ]
  2. Days of Exercise-induced Symptoms [ Time Frame: 12 months ]
  3. Days of Cough Without an Upper Respiratory Infection [ Time Frame: 12 months ]
  4. Nights of Wakening Due to Asthma Symptoms [ Time Frame: 12 months ]
  5. Number of Hospitalizations [ Time Frame: 12 months ]
  6. Emergency Department Visits [ Time Frame: 12 months ]
  7. Unscheduled Physician/Health Care Visits [ Time Frame: 12 months ]
  8. Prednisone Bursts [ Time Frame: 12 months ]
  9. FEV1/FVC [ Time Frame: 12 months ]
  10. FEV1 Percent Predicted [ Time Frame: 12 months ]
  11. Percent Change in FEV1 After Short-acting Beta Agonist [ Time Frame: 12 months ]
  12. Exhaled Nitric Oxide Levels [ Time Frame: 12 months ]

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

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

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 identifier (NCT number): NCT01756391

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

Publications of Results:
Other Publications:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Wanda Phipatanakul, Associate Professor of Pediatrics, Children's Hospital Boston Identifier: NCT01756391     History of Changes
Other Study ID Numbers: R01 AI 0739654
First Posted: December 25, 2012    Key Record Dates
Results First Posted: December 8, 2014
Last Update Posted: December 8, 2014
Last Verified: December 2014

Keywords provided by Wanda Phipatanakul, Children's Hospital Boston:

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