- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01913795
Environmental Intervention to Reduce Allergens in Urban Schools and Childhood Asthma
June 5, 2022 updated by: Wanda Phipatanakul, Boston Children's Hospital
The investigators aim to pilot the role of school based intervention consisting of enhanced integrated pest management, classroom air purifiers and cleaning improves asthma morbidity.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
By piloting this school based intervention, the investigators hope to learn from this study the best way to design and implement more cost and time efficient large-based school-based environmental interventions that may potentially help a community of children with asthma, allergic diseases, and its associated morbidity.
Study Type
Interventional
Enrollment (Actual)
29
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115
- Boston Children's Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
4 years to 15 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- grades K-8 with asthma attending sampling/intervention schools
Exclusion Criteria:
- moving schools
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Environmental Intervention
4 classroom air purifiers and school integrated pest management environmental intervention
|
integrated pest management and environmental strategy
air purifiers
|
Placebo Comparator: Sham and Control
4 sham air purifiers and no school integrated pest management environmental intervention
|
sham air purifiers
|
Placebo Comparator: Active Air Purifier and Control
4 air purifiers and no school integrated pest management environmental intervention
|
air purifiers
|
Sham Comparator: Sham and Integrated Pest Management
4 classroom sham air purifiers and school integrated pest management
|
integrated pest management and environmental strategy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Asthma Symptoms
Time Frame: over a two week period at Baseline and Months 3, 6, 9 and 12
|
number of days of wheezing/cough
|
over a two week period at Baseline and Months 3, 6, 9 and 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lung Function
Time Frame: measured at baseline and months 6 and 12
|
peak expiratory flow (PEF)
|
measured at baseline and months 6 and 12
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2013
Primary Completion (Actual)
July 1, 2015
Study Completion (Actual)
August 1, 2015
Study Registration Dates
First Submitted
May 21, 2013
First Submitted That Met QC Criteria
July 29, 2013
First Posted (Estimate)
August 1, 2013
Study Record Updates
Last Update Posted (Actual)
June 7, 2022
Last Update Submitted That Met QC Criteria
June 5, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 266134
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Asthma
-
Vanderbilt University Medical CenterNot yet recruitingAsthma in Children | Asthma Attack | Asthma Acute | Acute Asthma Exacerbation | Asthma; StatusUnited States
-
University of California, San FranciscoCompletedAsthma in Children | Asthma Attack | Asthma Acute | Asthma ChronicUnited States
-
SingHealth PolyclinicsNot yet recruitingAsthma | Asthma in Children | Asthma Attack | Asthma Acute | Asthma Chronic
-
Johann Wolfgang Goethe University HospitalCompleted
-
Parc de Salut MarActive, not recruitingAsthma in Children | Persistent Asthma | Asthma ExacerbationSpain
-
Universita di VeronaCompleted
-
Forest LaboratoriesCompleted
-
Brunel UniversityKarolinska InstitutetUnknown
-
Value Outcomes Ltd.AstraZenecaCompletedAsthma, Bronchial | Bronchial Asthma | Asthma Chronic | Asthma; EosinophilicCzechia
Clinical Trials on integrated pest management
-
New York City Department of Health and Mental HygieneMontefiore Medical Center; Healthfirst; Affinity Health PlanCompleted
-
National Institute of Environmental Health Sciences...CompletedAsthma | AllergyUnited States
-
Johns Hopkins UniversityColumbia University; Boston Children's HospitalCompletedAsthma | Mouse Allergy | Mouse Allergen ExposureUnited States
-
Boston Children's HospitalNational Institute of Allergy and Infectious Diseases (NIAID); National Institutes... and other collaboratorsCompleted
-
Huashan HospitalNot yet recruitingHypertension | Cardiovascular Risk Factor | Renal DiseaseChina
-
Dr Iris Tang Yan KiHospital Authority, Hong KongNot yet recruiting
-
Karen KlassenNational Health and Medical Research Council, Australia; Monash University; The... and other collaboratorsCompletedCardiovascular Disease | HIVAustralia
-
Chungbuk National UniversityCompleted
-
Kronikerenheden NordjyllandCompletedChronic Obstructive Pulmonary Disease (COPD)Denmark
-
Zohra Institute of Health SciencesUnknown