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OpenTrials
Completed

NCT Number: NCT01756391

Allergens in Inner-City Schools and Childhood Asthma

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

4 year–15 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital, Boston

Boston, Massachusetts, 02115, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Acronym: SICAS-1

Important dates

Study start
2008
Primary completion
2014
Study completion
2014
First posted
Dec 25, 2012
Registry last updated
Dec 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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