AsthmaSICAS-2NCT02291302

School Inner-City Asthma Intervention Study (SICAS-2)

A study testing integrated pest management and air purifier in people with 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

The investigators goal is to determine the efficacy of school/classroom based environmental intervention in reducing asthma morbidity in urban schoolchildren. Read more about this study

Who is it for?: Ages 4 to 15 yearsHealthy volunteers can take part
Conditions the study is for: Asthma
What is being tested?: integrated pest management and air purifier
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 236 participants
Where: 1 siteUnited States
Study dates: Jan 2015to Jun 2020
Phase: Interventional
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

Who may be able to join

grades K-8 with asthma attending sampling/intervention schools

Who cannot join

moving schools

Trial locations and contacts

1 site in 1 country.

United States1 site

Boston Children's Hospital
Boston, Massachusetts, 02115

Other trials in United States

About this study

Official title: School Inner-City Asthma Intervention Study

The investigators goal is to determine the efficacy of school/classroom based environmental intervention in reducing asthma morbidity in urban schoolchildren.

Read the detailed description

Our proposal builds upon our established, successful school-based infrastructure to determine whether a school/classroom intervention will efficiently and effectively improve asthma morbidity by reducing these exposures. Our goal is to determine the efficacy of school/classroom based environmental intervention in reducing asthma morbidity in urban schoolchildren. Our central hypothesis is that reducing classroom/school exposure to mouse allergen, mold, and particulate pollutants will decrease asthma morbidity in students with asthma. The investigators plan to test this hypothesis in an intervention study of 300 elementary students with asthma from multiple classrooms in inner-city elementary schools. Our clinical trial aims are to determine the effectiveness of a school/classroom based environmental intervention (school integrated pest management and classroom air purifying filter units within these schools) to reduce asthma morbidity. Our mechanistic aim is to test the hypothesis that effects of school/classroom-based environmental interventions on symptoms/other measures of asthma control occur through changes in gene methylation or expression in pathways (and secondarily, in genes) relevant to airway function and asthma. This will expand our understanding of asthma immunopathogenesis and create opportunities to identify potential novel targets for asthma therapy.

Conditions: Asthma
Being tested: integrated pest management, air purifier, No intervention (control)
Medical subject headings: Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

integrated pest managementOther
integrated pest management and environmental strategy
air purifierOther
air purifiers
No intervention (control)Other
no integrated pest management and sham air purifier

Study groups in NCT02291302
Study group	Role	What they receive
Environmental Intervention	Active comparator	Active Classroom air purifiers and school integrated pest management environmental intervention Receives: Other: integrated pest management; Other: air purifier
Sham and Control (control)	Placebo comparator	Sham air purifiers and no school integrated pest management environmental intervention Receives: Other: No intervention (control)
Active Air Purifier and Control	Placebo comparator	Active air purifiers and no school integrated pest management environmental intervention Receives: Other: air purifier
Sham and Inegrated Pest	Sham comparator	Sham air purifiers and active school integrated pest management Receives: Other: integrated pest management

What is being measured

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

Maximum Number of Days With Asthma Symptoms Within 2 Weeks
Maximum number of
1. Days with wheezing, tightness in the chest, or cough and/or
2. Nights with disturbed sleep as a result of asthma and/or
3. Days on which the child had to slow down or discontinue play activities because of asthma This is defined as a cumulative assessment from the different variables listed in the Measure Description
Measured: up to 12 months

Timeline

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

Jan 2015Jun 2020

First posted14 Nov 2014 (estimated)
Study startJan 2015
Primary completionJun 2020
Study completionJun 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for AsthmaStudies of the same condition, open and under way.
More trials run by Boston Children's HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

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

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 236 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02291302
Sponsor's protocol ID: U01AI110397
Other IDs: U01AI110397
Acronym: SICAS-2
Status last verified: Dec 2024
First submitted: 7 Nov 2014
Last updated: 7 Jan 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Kim M, Huang CY, Sun Y, Cunningham A, Tisza MJ, Gold D, Koutrakis P, Phipatanakul W, Lai PS. Classroom Microbiome Signatures of Pest Management Associate with Reduced Asthma Symptoms. J Allergy Clin Immunol. 2026 Aug 19:S0091-6749(26)00570-1. doi: 10.1016/j.jaci.2026.07.025. Online ahead of print.
PubMed 42617883
Hauptman M, Jackson-Browne MS, Busgang S, Andra SS, Patti MA, Henderson NB, Curtin P, Teitelbaum SL, Acosta K, Maciag M, Gaffin JM, Petty CR, Wright RO, Gold DR, Phipatanakul W. Urinary biomarkers of environmental exposures and asthma morbidity in a school inner city asthma study. Int J Hyg Environ Health. 2024 Sep;262:114430. doi: 10.1016/j.ijheh.2024.114430. Epub 2024 Aug 27.
PubMed 39205349
Ruran HB, Maciag MC, Murphy SE, Phipatanakul W, Hauptman M. Cross-sectional study of urinary biomarkers of environmental tobacco and e-cigarette exposure and asthma morbidity. Ann Allergy Asthma Immunol. 2022 Sep;129(3):378-380. doi: 10.1016/j.anai.2022.06.001. Epub 2022 Jun 7. No abstract available.
PubMed 35688366
Phipatanakul W, Koutrakis P, Coull BA, Petty CR, Gaffin JM, Sheehan WJ, Lai PS, Bartnikas LM, Kang CM, Wolfson JM, Samnaliev M, Cunningham A, Baxi SN, Permaul P, Hauptman M, Trivedi M, Louisias M, Liang L, Thorne PS, Metwali N, Adamkiewicz G, Israel E, Baccarelli AA, Gold DR; School Inner-City Asthma Intervention study team. Effect of School Integrated Pest Management or Classroom Air Filter Purifiers on Asthma Symptoms in Students With Active Asthma: A Randomized Clinical Trial. JAMA. 2021 Sep 7;326(9):839-850. doi: 10.1001/jama.2021.11559.
PubMed 34547084
Kantor DB, Petty CR, Phipatanakul W, Gaffin JM. Transcutaneous CO-oximetry differentiates asthma exacerbation and convalescence in children. J Allergy Clin Immunol. 2018 Aug;142(2):676-678.e5. doi: 10.1016/j.jaci.2018.02.048. Epub 2018 Apr 16. No abstract available.
PubMed 29673798

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: School Inner-City Asthma Intervention Study
ClinicalTrials.gov ID: NCT02291302
Acronym / sponsor ID: SICAS-2 / U01AI110397
Conditions: Asthma
Study type: Interventional
Recruitment status: Completed
Enrolment: 236 participants (actual)
Lead sponsor: Boston Children's HospitalUniversity, hospital or other
Collaborators: National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID), Harvard School of Public Health (HSPH)
Study start: Jan 2015 (actual)
Primary completion: Jun 2020 (actual)
Study completion: Jun 2020 (actual)
First posted: 14 Nov 2014 (estimated)
Results: Posted 23 Sep 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The investigators goal is to determine the efficacy of school/classroom based environmental intervention in reducing asthma morbidity in urban schoolchildren.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Environmental Intervention	Active comparator	Other: integrated pest management, Other: air purifierActive Classroom air purifiers and school integrated pest management environmental intervention
Sham and Control (control)	Placebo comparator	Other: No intervention (control)Sham air purifiers and no school integrated pest management environmental intervention
Active Air Purifier and Control	Placebo comparator	Other: air purifierActive air purifiers and no school integrated pest management environmental intervention
Sham and Inegrated Pest	Sham comparator	Other: integrated pest managementSham air purifiers and active school integrated pest management

Who may qualify

Ages: 4 to 15 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (1 listed)

grades K-8 with asthma attending sampling/intervention schools

Key exclusion criteria (1 listed)

moving schools

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
integrated pest managementintegrated pest management and environmental strategy	Other	Environmental Intervention, Sham and Inegrated Pest
air purifierair purifiers	Other	Active Air Purifier and Control, Environmental Intervention
No intervention (control)no integrated pest management and sham air purifier	Other	Sham and Control (control)

Primary outcome

Maximum Number of Days With Asthma Symptoms Within 2 Weeks
Time frame: up to 12 months
Maximum number of 1. Days with wheezing, tightness in the chest, or cough and/or 2. Nights with disturbed sleep as a result of asthma and/or 3. Days on which the child had to slow down or discontinue play activities because of asthma This is defined as a cumulative assessment from the different variables listed in the Measure Description

Results and safety

Results posted to the registry on 23 Sep 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Environmental Intervention	59	59
Sham and Control (Control)	59	59
Active Air Purifier and Control	59	59
Sham and Inegrated Pest	59	59

Primary outcome: Maximum Number of Days With Asthma Symptoms Within 2 Weeks

Time frame: up to 12 months. Mean (Standard Deviation). Unit: days

Measure	Environmental Intervention n = 59	Sham and Control (Control) n = 59	Active Air Purifier and Control n = 59	Sham and Inegrated Pest n = 59
Value	2.2 (3.5)	2.7 (4.4)	1.2 (2)	2.1 (3.6)

Adverse events

Time frame: until study completion an average of 1 year. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Environmental Intervention	0 of 59 (0%)	0 of 59 (0%)	0 of 59
Sham and Control (Control)	0 of 59 (0%)	0 of 59 (0%)	0 of 59
Active Air Purifier and Control	0 of 59 (0%)	0 of 59 (0%)	0 of 59
Sham and Inegrated Pest	0 of 59 (0%)	0 of 59 (0%)	0 of 59

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 42617883Kim M, Huang CY, Sun Y, Cunningham A, Tisza MJ, Gold D, Koutrakis P, Phipatanakul W, Lai PS. Classroom Microbiome Signatures of Pest Management Associate with Reduced Asthma Symptoms. J Allergy Clin Immunol. 2026 Aug 19:S0091-6749(26)00570-1. doi: 10.1016/j.jaci.2026.07.025. Online ahead of print.
Derived from this study: PubMed 39205349Hauptman M, Jackson-Browne MS, Busgang S, Andra SS, Patti MA, Henderson NB, Curtin P, Teitelbaum SL, Acosta K, Maciag M, Gaffin JM, Petty CR, Wright RO, Gold DR, Phipatanakul W. Urinary biomarkers of environmental exposures and asthma morbidity in a school inner city asthma study. Int J Hyg Environ Health. 2024 Sep;262:114430. doi: 10.1016/j.ijheh.2024.114430. Epub 2024 Aug 27.
Derived from this study: PubMed 35688366Ruran HB, Maciag MC, Murphy SE, Phipatanakul W, Hauptman M. Cross-sectional study of urinary biomarkers of environmental tobacco and e-cigarette exposure and asthma morbidity. Ann Allergy Asthma Immunol. 2022 Sep;129(3):378-380. doi: 10.1016/j.anai.2022.06.001. Epub 2022 Jun 7. No abstract available.
Derived from this study: PubMed 34547084Phipatanakul W, Koutrakis P, Coull BA, Petty CR, Gaffin JM, Sheehan WJ, Lai PS, Bartnikas LM, Kang CM, Wolfson JM, Samnaliev M, Cunningham A, Baxi SN, Permaul P, Hauptman M, Trivedi M, Louisias M, Liang L, Thorne PS, Metwali N, Adamkiewicz G, Israel E, Baccarelli AA, Gold DR; School Inner-City Asthma Intervention study team. Effect of School Integrated Pest Management or Classroom Air Filter Purifiers on Asthma Symptoms in Students With Active Asthma: A Randomized Clinical Trial. JAMA. 2021 Sep 7;326(9):839-850. doi: 10.1001/jama.2021.11559.
Derived from this study: PubMed 29673798Kantor DB, Petty CR, Phipatanakul W, Gaffin JM. Transcutaneous CO-oximetry differentiates asthma exacerbation and convalescence in children. J Allergy Clin Immunol. 2018 Aug;142(2):676-678.e5. doi: 10.1016/j.jaci.2018.02.048. Epub 2018 Apr 16. No abstract available.

Related trials for Asthma

Active, not recruitingPhase 3
A Multicentre, Randomised, Double-blind, Parallel Group, Placebo-controlled, Time-to-first Asthma Exacerbation Phase III Efficacy and Safety Study of Benralizumab in Paediatric Patients With Severe Eosinophilic Asthma
Asthma
Not yet recruitingPhase 1
Study of HXN-1013 in Healthy Participants and Participants With Mild-to-Moderate Asthma
Health Adults, Asthma
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
RecruitingPhase 1
A Phase 1 Trial of AMG 691 in Healthy Chinese and Japanese Volunteers
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RecruitingPhase 1/2
A Study of HB0056 in Adult Participants With Moderate to Severe Asthma
Asthma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Wanda Phipatanakul, MD, MS principal investigator

Boston Children's Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing integrated pest management and air purifier in people with 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 1 inclusion and 1 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 7 Jan 2025. 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. Some participants in this study may receive a placebo. 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 23 Sep 2020). 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 Number of Days With Asthma Symptoms Within 2 Weeks (time frame: up to 12 months). 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 NCT02291302, which also lists 5 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 7 Jan 2025.