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AsthmaSICAS-1NCT01756391

Allergens in Inner-City Schools and Childhood Asthma

An observational study of Asthma, run by Boston Children's Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 4 to 15 yearsHealthy volunteers can take part
Conditions the study is for
Asthma
How many people
351 participants
Where
1 siteUnited States
Study dates
Mar 2008to Oct 2014
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 to 15 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Study population: elementary school students with asthma

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Children's Hospital, Boston

    Boston, Massachusetts, 02115

Other trials in United States

About this study

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
Medical subject headings
Asthma, Hypersensitivity

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 14 days

Secondary outcomes (12)

  1. Days of Slowed Activity Due to Asthma

    Measured: 12 months

  2. Days of Exercise-induced Symptoms

    Measured: 12 months

  3. Days of Cough Without an Upper Respiratory Infection

    Measured: 12 months

  4. Nights of Wakening Due to Asthma Symptoms

    Measured: 12 months

  5. Number of Hospitalizations

    Measured: 12 months

  6. Emergency Department Visits

    Measured: 12 months

  7. Unscheduled Physician/Health Care Visits

    Measured: 12 months

  8. Prednisone Bursts

    Measured: 12 months

  9. FEV1/FVC

    Measured: 12 months

  10. FEV1 Percent Predicted

    Measured: 12 months

  11. Percent Change in FEV1 After Short-acting Beta Agonist

    Measured: 12 months

  12. Exhaled Nitric Oxide Levels

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Dec 2012 (estimated)
  2. Study startMar 2008
  3. Primary completionOct 2014
  4. Study completionOct 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
351 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01756391
Sponsor's protocol ID
R01 AI 0739654
Acronym
SICAS-1
Status last verified
Dec 2014
First submitted
20 Dec 2012
Last updated
8 Dec 2014
Data monitoring committee
No

Publications

  • 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.

    PubMed 23176873

  • 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.

    PubMed 23062384

  • 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.

    PubMed 22742446

  • 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.

    PubMed 21710109

  • 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.

    PubMed 22672325

  • 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.

    PubMed 22626594

  • 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.

    PubMed 22010992

  • 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.

    PubMed 21962100

  • 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.

    PubMed 31557500

  • 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.

    PubMed 30904580

  • 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.

    PubMed 26087201

Questions about this trial

What is this clinical trial studying?

An observational study of Asthma, run by Boston Children's Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Dec 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Symptom Days/14 Days (time frame: 14 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01756391, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2014.

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