Clinical trial NCT01756391: Allergens in Inner-City Schools and Childhood Asthma
Official title: Allergens in Inner-City Schools and Childhood Asthma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Keywords: pediatric
childhood
allergy
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2012-12-25
Enrollment: 351
Sex: ALL
Minimum age (years): 4
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: elementary school students with asthma

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.


Eligibility 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

Primary outcomes:
measure: Maximum Symptom Days/14 Days
timeFrame: 14 days
Secondary outcomes:
measure: Days of Slowed Activity Due to Asthma
timeFrame: 12 months
measure: Days of Exercise-induced Symptoms
timeFrame: 12 months
measure: Days of Cough Without an Upper Respiratory Infection
timeFrame: 12 months
measure: Nights of Wakening Due to Asthma Symptoms
timeFrame: 12 months
measure: Number of Hospitalizations
timeFrame: 12 months
measure: Emergency Department Visits
timeFrame: 12 months
measure: Unscheduled Physician/Health Care Visits
timeFrame: 12 months
measure: Prednisone Bursts
timeFrame: 12 months
measure: FEV1/FVC
timeFrame: 12 months
measure: FEV1 Percent Predicted
timeFrame: 12 months
measure: Percent Change in FEV1 After Short-acting Beta Agonist
timeFrame: 12 months
measure: Exhaled Nitric Oxide Levels
timeFrame: 12 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Children's Hospital, Boston
state: Massachusetts
Study officials:
References:
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. No abstract available.
citation: 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.
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.
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.
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.1399-3038.2012.01327.x. Epub 2012 Jun 6.
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. doi: 10.1016/j.anai.2012.04.003. Epub 2012 Apr 26.
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: 10.3109/02770903.2011.624235. Epub 2011 Oct 20.
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. Ann Allergy Asthma Immunol. 2011 Oct;107(4):371-3. doi: 10.1016/j.anai.2011.08.007. No abstract available.
citation: Hauptman M, Gaffin JM, Petty CR, Sheehan WJ, Lai PS, Coull B, Gold DR, Phipatanakul W. Proximity to major roadways and asthma symptoms in the School Inner-City Asthma Study. J Allergy Clin Immunol. 2020 Jan;145(1):119-126.e4. doi: 10.1016/j.jaci.2019.08.038. Epub 2019 Sep 23.
citation: Baxi SN, Sheehan WJ, Sordillo JE, Muilenberg ML, Rogers CA, Gaffin JM, Permaul P, Lai PS, Louisias M, Petty CR, Fu C, Gold DR, Phipatanakul W. Association between fungal spore exposure in inner-city schools and asthma morbidity. Ann Allergy Asthma Immunol. 2019 Jun;122(6):610-615.e1. doi: 10.1016/j.anai.2019.03.011. Epub 2019 Mar 20.
citation: Lai PS, Sheehan WJ, Gaffin JM, Petty CR, Coull BA, Gold DR, Phipatanakul W. School Endotoxin Exposure and Asthma Morbidity in Inner-city Children. Chest. 2015 Nov;148(5):1251-1258. doi: 10.1378/chest.15-0098.