Allergens in Inner-City Schools and Childhood Asthma

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Children's Hospital Boston
Information provided by (Responsible Party):
Wanda Phipatanakul, Children's Hospital Boston Identifier:
First received: December 20, 2012
Last updated: July 29, 2013
Last verified: July 2013

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

Resource links provided by NLM:

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

Primary Outcome Measures:
  • maximum days of symptoms/ 2 weeks [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Maximum days of asthma symptoms will be assessed by questionnaire

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 ]

Estimated Enrollment: 400
Study Start Date: March 2008
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   4 Years to 15 Years
Genders Eligible for Study:   Both
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 5-15)
  • 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 identifier: NCT01756391

Contact: Wanda Phipatanakul, MD, MS 857-218-5336
Contact: Ann Bailey 617-525-0876

United States, Massachusetts
Children's Hospital, Boston Recruiting
Boston, Massachusetts, United States, 02115
Contact: Wanda Phipatanakul, MD, MS    857-218-5536   
Principal Investigator: Wanda Phipatanakul, MD,MS         
Sponsors and Collaborators
Children's Hospital Boston
  More Information


Responsible Party: Wanda Phipatanakul, Associate Professor of Pediatrics, Children's Hospital Boston Identifier: NCT01756391     History of Changes
Other Study ID Numbers: R01 AI 0739654
Study First Received: December 20, 2012
Last Updated: July 29, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital Boston:

Additional relevant MeSH terms:
Bronchial Diseases
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases processed this record on October 20, 2014