Allergens in Inner-City Schools and Childhood Asthma

NCT01756391 | Completed Results

• 1 other identifier: R01 AI 0739654
• Study Type: observational
• Target: 351
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Keywords

pediatric; childhood; allergy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (12)

• Days of Slowed Activity Due to Asthma

  12 months

• Days of Exercise-induced Symptoms

  12 months

• Days of Cough Without an Upper Respiratory Infection

  12 months

• Nights of Wakening Due to Asthma Symptoms

  12 months

• Number of Hospitalizations

  12 months

Eligibility Criteria

• Age: 4 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

elementary school students with asthma

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Children's Hospital: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Children's Hospital, Boston

Boston, Massachusetts, 02115, United States

Location

Related Publications (11)

• 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.

  PMID: 23176873 BACKGROUND

• 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.

  PMID: 23062384 BACKGROUND

• 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.

  PMID: 22742446 BACKGROUND

• 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.

  PMID: 21710109 BACKGROUND

• 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.

  PMID: 22672325 RESULT

• 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.

  PMID: 22626594 RESULT

• 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.

  PMID: 22010992 RESULT

• 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.

  PMID: 21962100 RESULT

• 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.

  PMID: 31557500 DERIVED

• 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.

  PMID: 30904580 DERIVED

• 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.

  PMID: 26087201 DERIVED

MeSH Terms

Conditions

Asthma; Hypersensitivity

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Wanda Phipatanakul
• Organization: Boston Children's Hospital

wanda.phipatanakul@childrens.harvard.edu

617-355-6117

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics

Study Record Dates

• First Submitted: December 20, 2012
• First Posted: December 25, 2012
• Study Start: March 1, 2008
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: December 8, 2014
• Results First Posted: December 8, 2014

Record last verified: 2014-12

Locations

US (1)