Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U01AI110397 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
| Harvard School of Public Health (HSPH) | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The investigators goal is to determine the efficacy of school/classroom based environmental intervention in reducing asthma morbidity in urban schoolchildren.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Environmental Intervention | Active Comparator | Active Classroom air purifiers and school integrated pest management environmental intervention |
|
| Sham and Control (control) | Placebo Comparator | Sham air purifiers and no school integrated pest management environmental intervention |
|
| Active Air Purifier and Control | Placebo Comparator | Active air purifiers and no school integrated pest management environmental intervention |
|
| Sham and Inegrated Pest | Sham Comparator | Sham air purifiers and active school integrated pest management |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| integrated pest management | Other | integrated pest management and environmental strategy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Number of Days With Asthma Symptoms Within 2 Weeks | Maximum number of
| up to 12 months |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Lung Function | Spirometry measure of forced expiration volume in 1 second | 12 months |
| School Absences | Number of school days missed because of asthma/ 2 weeks |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Wanda Phipatanakul, MD, MS | Boston Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Children's Hospital | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39205349 | Derived | 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. | |
| 35688366 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Environmental Intervention | Active Classroom air purifiers and school integrated pest management environmental intervention integrated pest management: integrated pest management and environmental strategy air purifier: air purifiers |
| FG001 | Sham and Control (Control) | Sham air purifiers and no school integrated pest management environmental intervention No intervention (control): no integrated pest management and sham air purifier |
| FG002 | Active Air Purifier and Control | Active air purifiers and no school integrated pest management environmental intervention air purifier: air purifiers |
| FG003 | Sham and Inegrated Pest | Sham air purifiers and active school integrated pest management integrated pest management: integrated pest management and environmental strategy |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Environmental Intervention | Active Classroom air purifiers and school integrated pest management environmental intervention integrated pest management: integrated pest management and environmental strategy air purifier: air purifiers |
| BG001 | Sham and Control (Control) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maximum Number of Days With Asthma Symptoms Within 2 Weeks | Maximum number of
| Posted | Mean | Standard Deviation | days | up to 12 months |
|
until study completion an average of 1 year
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Environmental Intervention | Active Classroom air purifiers and school integrated pest management environmental intervention integrated pest management: integrated pest management and environmental strategy air purifier: air purifiers |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Wanda Phipatanakul, MD. MS. | Boston Children's Hospital | 617-355-6117 | wanda.phipatanakul@childrens.harvard.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 27, 2015 | Sep 1, 2020 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D061808 | Air Filters |
| ID | Term |
|---|---|
| D005374 | Filtration |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| D004864 | Equipment and Supplies |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| air purifier | Other | air purifiers |
|
| No intervention (control) | Other | no integrated pest management and sham air purifier |
|
| 12 months |
| Composite Asthma Severity Index | [a comprehensive severity scale of day symptoms and albuterol use, night symptoms and albuterol use, controller treatment, lung function measures, and exacerbations], health care utilization, and pulmonary function testing (PFT's) including FEV1; FEV1/FVC, FEF25-75. CASI ranges from 0 (lowest) -20 points (highest) with a minimal clinically important difference of 0.49 points. The higher score is worse outcome. | 12 months |
| 34547084 | Derived | 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. |
| 29673798 | Derived | 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. |
Sham air purifiers and no school integrated pest management environmental intervention No intervention (control): no integrated pest management and sham air purifier |
| BG002 | Active Air Purifier and Control | Active air purifiers and no school integrated pest management environmental intervention air purifier: air purifiers |
| BG003 | Sham and Inegrated Pest | Sham air purifiers and active school integrated pest management integrated pest management: integrated pest management and environmental strategy |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Maximum Number of Days With Asthma Symptoms Within 2 Weeks | Mean | Standard Deviation | days |
|
Sham air purifiers and no school integrated pest management environmental intervention
No intervention (control): no integrated pest management and sham air purifier
| OG002 | Active Air Purifier and Control | Active air purifiers and no school integrated pest management environmental intervention air purifier: air purifiers |
| OG003 | Sham and Inegrated Pest | Sham air purifiers and active school integrated pest management integrated pest management: integrated pest management and environmental strategy |
|
|
| Other Pre-specified | Lung Function | Spirometry measure of forced expiration volume in 1 second | Posted | Mean | Standard Deviation | percentage of predicted | 12 months |
|
|
|
| Other Pre-specified | School Absences | Number of school days missed because of asthma/ 2 weeks | Posted | Mean | Standard Deviation | days/2 weeks | 12 months |
|
|
|
| Other Pre-specified | Composite Asthma Severity Index | [a comprehensive severity scale of day symptoms and albuterol use, night symptoms and albuterol use, controller treatment, lung function measures, and exacerbations], health care utilization, and pulmonary function testing (PFT's) including FEV1; FEV1/FVC, FEF25-75. CASI ranges from 0 (lowest) -20 points (highest) with a minimal clinically important difference of 0.49 points. The higher score is worse outcome. | Posted | Mean | Standard Deviation | score on a scale | 12 months |
|
|
|
| Post-Hoc | Classroom Viral Exposure | Classroom viral exposure will be assessed using two approaches:
| Not Posted | Dec 2025 | 1 year | Participants |
| Post-Hoc | Classroom Microbiome | The classroom microbiome will be assessed with deep metagenomics sequencing | Not Posted | Dec 2025 | 1 year | Participants |
| 0 |
| 59 |
| 0 |
| 59 |
| 0 |
| 59 |
| EG001 | Sham and Control (Control) | Sham air purifiers and no school integrated pest management environmental intervention No intervention (control): no integrated pest management and sham air purifier | 0 | 59 | 0 | 59 | 0 | 59 |
| EG002 | Active Air Purifier and Control | Active air purifiers and no school integrated pest management environmental intervention air purifier: air purifiers | 0 | 59 | 0 | 59 | 0 | 59 |
| EG003 | Sham and Inegrated Pest | Sham air purifiers and active school integrated pest management integrated pest management: integrated pest management and environmental strategy | 0 | 59 | 0 | 59 | 0 | 59 |
Not provided
Not provided
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |