Allergens in Inner-City Schools and Childhood Asthma

Asthma Clinical Trial

— SICAS-1  

Official title:

Allergens in Inner-City Schools and Childhood Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01756391
• Other study ID #: R01 AI 0739654
• Status: Completed
• Phase: N/A
• First received: December 20, 2012
• Last updated: December 4, 2014
• Start date: March 2008
• Est. completion date: October 2014

Study information

• Verified date: December 2014
• Source: Children's Hospital Boston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 351
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 4 Years to 15 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Asthma

Locations

Country	Name	City	State
United States	Children's Hospital, Boston	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital Boston	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (8)

Bartnikas LM, Sheehan WJ, Hoffman EB, Permaul P, Dioun AF, Friedlander J, Baxi SN, Schneider LC, Phipatanakul W. Predicting food challenge outcomes for baked milk: role of specific IgE and skin prick testing. Ann Allergy Asthma Immunol. 2012 Nov;109(5):309-313.e1. doi: 10.1016/j.anai.2012.07.026. Epub 2012 Aug 21. — View Citation

Baxi SN, Sheehan WJ, Gaffin JM, Yodying J, Panupattanapong S, Lane JP, Fu C, Hoffman EB, Gold DR, Phipatanakul W. Agreement between parent and student responses to an asthma and allergy questionnaire in a diverse, inner-city elementary school population. — View Citation

Permaul P, Hoffman E, Fu C, Sheehan W, Baxi S, Gaffin J, Lane J, Bailey A, King E, Chapman M, Gold D, Phipatanakul W. Allergens in urban schools and homes of children with asthma. Pediatr Allergy Immunol. 2012 Sep;23(6):543-9. doi: 10.1111/j.1399-3038.201 — View Citation

Phipatanakul W, Bailey A, Hoffman EB, Sheehan WJ, Lane JP, Baxi S, Rao D, Permaul P, Gaffin JM, Rogers CA, Muilenberg ML, Gold DR. The school inner-city asthma study: design, methods, and lessons learned. J Asthma. 2011 Dec;48(10):1007-14. doi: 10.3109/02 — View Citation

Phipatanakul W, Matsui E, Portnoy J, Williams PB, Barnes C, Kennedy K, Bernstein D, Blessing-Moore J, Cox L, Khan D, Lang D, Nicklas R, Oppenheimer J, Randolph C, Schuller D, Spector S, Tilles SA, Wallace D, Sublett J, Bernstein J, Grimes C, Miller JD, Seltzer J; Joint Task Force on Practice Parameters. Environmental assessment and exposure reduction of rodents: a practice parameter. Ann Allergy Asthma Immunol. 2012 Dec;109(6):375-87. doi: 10.1016/j.anai.2012.09.019. — View Citation

Rao D, Phipatanakul W. Impact of environmental controls on childhood asthma. Curr Allergy Asthma Rep. 2011 Oct;11(5):414-20. doi: 10.1007/s11882-011-0206-7. Review. — View Citation

Rao DR, Gaffin JM, Baxi SN, Sheehan WJ, Hoffman EB, Phipatanakul W. The utility of forced expiratory flow between 25% and 75% of vital capacity in predicting childhood asthma morbidity and severity. J Asthma. 2012 Aug;49(6):586-92. doi: 10.3109/02770903.2012.690481. Epub 2012 Jun 28. — View Citation

Sheehan WJ, Hoffman EB, Fu C, Baxi SN, Bailey A, King EM, Chapman MD, Lane JP, Gaffin JM, Permaul P, Gold DR, Phipatanakul W. Endotoxin exposure in inner-city schools and homes of children with asthma. Ann Allergy Asthma Immunol. 2012 Jun;108(6):418-22. d — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Symptom Days/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	No
Secondary	Days of Slowed Activity Due to Asthma		12 months	No
Secondary	Days of Exercise-induced Symptoms		12 months	No
Secondary	Days of Cough Without an Upper Respiratory Infection		12 months	No
Secondary	Nights of Wakening Due to Asthma Symptoms		12 months	No
Secondary	Number of Hospitalizations		12 months	No
Secondary	Emergency Department Visits		12 months	No
Secondary	Unscheduled Physician/Health Care Visits		12 months	No
Secondary	Prednisone Bursts		12 months	No
Secondary	FEV1/FVC		12 months	No
Secondary	FEV1 Percent Predicted		12 months	No
Secondary	Percent Change in FEV1 After Short-acting Beta Agonist		12 months	No
Secondary	Exhaled Nitric Oxide Levels		12 months	No