AsthmaNCT01913795
Environmental Intervention to Reduce Allergens in Urban Schools and Childhood Asthma
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.
Trial summary
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. 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
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to Aug 2015
- 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
About this study
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.
Read the 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.
- Conditions
- Asthma
- Being tested
- integrated pest management, air purifier, Sham air purifier
- 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
Sham air purifierOther
sham air purifiers
| Study group | Role | What they receive |
|---|---|---|
| Environmental Intervention | Active comparator | 4 classroom air purifiers and school integrated pest management environmental intervention Receives: Other: integrated pest management; Other: air purifier |
| Sham and Control | Placebo comparator | 4 sham air purifiers and no school integrated pest management environmental intervention Receives: Other: Sham air purifier |
| Active Air Purifier and Control | Placebo comparator | 4 air purifiers and no school integrated pest management environmental intervention Receives: Other: air purifier |
| Sham and Integrated Pest Management | Sham comparator | 4 classroom sham air purifiers and 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.
Asthma Symptoms
number of days of wheezing/cough
Measured: over a two week period at Baseline and Months 3, 6, 9 and 12
Secondary outcomes (1)
Lung Function
peak expiratory flow (PEF)
Measured: measured at baseline and months 6 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2013 (estimated)
- Study startMay 2013
- Primary completionJul 2015
- Study completionAug 2015
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.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wanda Phipatanakul, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01913795
- Sponsor's protocol ID
- 266134
- Status last verified
- Jun 2022
- First submitted
- 21 May 2013
- Last updated
- 7 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Environmental Intervention to Reduce Allergens in Urban Schools and Childhood Asthma
- ClinicalTrials.gov ID
- NCT01913795
- Acronym / sponsor ID
- 266134
- Conditions
- Asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 1 Aug 2013 (estimated)
- Results
- Posted 14 Oct 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Environmental Intervention | Active comparator | Other: integrated pest management, Other: air purifier4 classroom air purifiers and school integrated pest management environmental intervention |
| Sham and Control | Placebo comparator | Other: Sham air purifier4 sham air purifiers and no school integrated pest management environmental intervention |
| Active Air Purifier and Control | Placebo comparator | Other: air purifier4 air purifiers and no school integrated pest management environmental intervention |
| Sham and Integrated Pest Management | Sham comparator | Other: integrated pest management4 classroom sham air purifiers and 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 Integrated Pest Management |
| air purifierair purifiers | Other | Active Air Purifier and Control, Environmental Intervention |
| Sham air purifiersham air purifiers | Other | Sham and Control |
Primary outcome
Asthma Symptoms
Time frame: over a two week period at Baseline and Months 3, 6, 9 and 12
number of days of wheezing/cough
1 secondary outcome
Lung Function
Time frame: measured at baseline and months 6 and 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Jun 2022. 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 14 Oct 2015). 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?
Asthma Symptoms (time frame: over a two week period at Baseline and Months 3, 6, 9 and 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jun 2022.