Asthma in ChildrenDAISYNCT06552013
Action Towards Health Equity and Improved Air Quality in the Duwamish Valley: A Multilevel Asthma Intervention
A study testing MERV 13 filter in people with Asthma in Children, run by University of Washington at 1 site in United States.
Trial summary
The goal of this randomized control trial is to learn if box fans and filters can reduce asthma symptoms and improve indoor air quality in children ages 6 - 17 years old with asthma living in the Duwamish Valley, Seattle, Washington. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Asthma in Children
- What is being tested?
- MERV 13 filter
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jul 2024to Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- age (6-17 years)
- poorly controlled physician diagnosed asthma defined as more than four days with asthma symptoms in the past two weeks, use of asthma rescue medication for more than four days in the past two weeks, or health care utilization due to asthma in the past year (hospitalization, emergency room visit, or unscheduled clinic visit)
- living in Georgetown and South Park neighborhoods of Seattle
Who cannot join
- children with unstable housing or shared custody arrangements
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Duwamish River Community Coaltion
Seattle, Washington, 98108
Joseph Santana, MPH, 253-235-9148, joseph@drcc.org
About this study
The goal of this randomized control trial is to learn if box fans and filters can reduce asthma symptoms and improve indoor air quality in children ages 6 - 17 years old with asthma living in the Duwamish Valley, Seattle, Washington. The main question it aims to answer are:
- Do box fans with filters improve asthma symptoms?
- Do box fans with filters improve an objective measure used to monitor lung function known as forced expiratory volume during the first second (FEV1)? Researchers will compare children living in households with high quality filters to those in households with sham filters to see if air quality and asthma symptoms improve.
Read more
Participants will
- fill out several questionnaires
- monitor their lung function with a peak flow meter
- place an air monitor in their homes to monitor indoor air quality
- run the box fan when they are at home
- Conditions
- Asthma in Children
- Being tested
- MERV 13 filter, Sham filter
- Keywords
- air quality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MERV 13 filterOther
This is an environmental intervention consisting of a low-cost box fan with a MERV 13 filter placed behind it. The company Lasko makes these fans and other environmental appliances.
Sham filterOther
This is an environmental intervention consisting of a low-cost box fan with a sham filter (MERV 1) placed behind it. The company Lasko makes these fans and other environmental appliances.
| Study group | Role | What they receive |
|---|---|---|
| Sham filter | Experimental | Participants in this arm will receive a sham filter for their box fans. These filters receive a MERV rating of 1 and only filter very large particles and debris such as lint, hair and insects. These particles have little to no impact on asthma symptoms. MERV stands for "minimum efficiency reporting value" and a filter receives a MERV rating as determined by the American Society of Heating, Refrigeration, and Air-Conditioning Engineers. Receives: Other: Sham filter |
| MERV 13 filter | Experimental | Participants in this arm will receive a MERV 13 filter for their box fans. MERV 13 filters trap the majority of small particles, as small as 1 micron. It also traps up to 75% of particles that are as small as 0.3 microns. Receives: Other: MERV 13 filter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma symptoms
Symptoms are evaluated with the seven-item asthma control questionnaire (ACQ), a validated tool used in children.
Measured: ACQ will be measured weekly for 6 consecutive weeks, two pre-intervention weeks (before box fans have been given to participant) and four weeks while fans are being used in the home. Symptoms will also be assessed at the six month follow-up visit.
FEV1
FEV1 is captured with a digital peak flow meter.
Measured: FEV1 measures will be taken daily, once in the morning and once at night for the six week study time frame. Prior to the six month follow up we will ask participants to take three consecutive days of FEV1 measurements, for an additional 6 measures
Secondary outcomes (3)
Asthma quality of life
Will be assessed with the15-item mini-asthma quality of life questionnaire, a validated tool
Measured: Will be evaluated at baseline (visit 1), after 6 weeks (visit 3) and at 6 month follow up (visit 4)
Use of rescue medications
This is an item on the ACQ. See primary outcome.
Measured: ACQ will be measured weekly for 6 consecutive weeks, two pre-intervention weeks (before box fans have been given to participant) and four weeks while fans are being used in the home. Symptoms will also be assessed at the six month follow-up visit.
Health care utilization in the past month
Will be assessed with the six-item asthma-related health care utilization questionnaire.
Measured: Will be evaluated at baseline (visit 1), after 6 weeks (visit 3) and at 6 month follow up (visit 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2024
- Study start30 Jul 2024
- Primary completionJul 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma in ChildrenStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Environmental Health Sciences (NIEHS)
- Responsible party
- Principal investigator, Anjum Hajat, University of Washington
- Investigators
- Anjum Hajat, PhD, MPH, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06552013
- Sponsor's protocol ID
- STUDY00018735
- Other IDs
- 1R01ES034749-01
- Acronym
- DAISY
- Status last verified
- Aug 2024
- First submitted
- 9 Aug 2024
- Last updated
- 13 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Only de-identified individual level data sets will be shared. Given the small sample size of our study, we will protect against deductive disclosure by withholding information that could result in disclosure. We will also require interested investigators to provide a proposal that will outline their study question and analytic methods. If there is any overlap with ongoing manuscripts, we will ask investigators to collaborate with ongoing efforts or to propose an alternative study question. Investigators will be required to sign a data sharing agreement that will include assurances about participant privacy and data confidentiality. We do not anticipate a great number of requests for our data so will handle them on an individual basis. After discussing the data with investigators who are interested in accessing it, we will share it via a secure site.
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Action Towards Health Equity and Improved Air Quality in the Duwamish Valley: A Multilevel Asthma Intervention
- ClinicalTrials.gov ID
- NCT06552013
- Acronym / sponsor ID
- DAISY / STUDY00018735
- Conditions
- Asthma in Children
- Keywords
- air quality
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute of Environmental Health Sciences (NIEHS)
- Study start
- 30 Jul 2024 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 13 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this randomized control trial is to learn if box fans and filters can reduce asthma symptoms and improve indoor air quality in children ages 6 - 17 years old with asthma living in the Duwamish Valley, Seattle, Washington. The main question it aims to answer are:
- Do box fans with filters improve asthma symptoms?
- Do box fans with filters improve an objective measure used to monitor lung function known as forced expiratory volume during the first second (FEV1)? Researchers will compare children living in households with high quality filters to those in households with sham filters to see if air quality and asthma symptoms improve.
Participants will
- fill out several questionnaires
- monitor their lung function with a peak flow meter
- place an air monitor in their homes to monitor indoor air quality
- run the box fan when they are at home
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham filter | Experimental | Other: Sham filterParticipants in this arm will receive a sham filter for their box fans. These filters receive a MERV rating of 1 and only filter very large particles and debris such as lint, hair and insects. These particles have little to no impact on asthma symptoms. MERV stands for "minimum efficiency reporting value" and a filter receives a MERV rating as determined by the American Society of Heating, Refrigeration, and Air-Conditioning Engineers. |
| MERV 13 filter | Experimental | Other: MERV 13 filterParticipants in this arm will receive a MERV 13 filter for their box fans. MERV 13 filters trap the majority of small particles, as small as 1 micron. It also traps up to 75% of particles that are as small as 0.3 microns. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- age (6-17 years)
- poorly controlled physician diagnosed asthma defined as more than four days with asthma symptoms in the past two weeks, use of asthma rescue medication for more than four days in the past two weeks, or health care utilization due to asthma in the past year (hospitalization, emergency room visit, or unscheduled clinic visit)
- living in Georgetown and South Park neighborhoods of Seattle
Key exclusion criteria (1 listed)
- children with unstable housing or shared custody arrangements
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 |
|---|---|---|
| MERV 13 filterThis is an environmental intervention consisting of a low-cost box fan with a MERV 13 filter placed behind it. The company Lasko makes these fans and other environmental appliances. | Other | MERV 13 filter |
| Sham filterThis is an environmental intervention consisting of a low-cost box fan with a sham filter (MERV 1) placed behind it. The company Lasko makes these fans and other environmental appliances. | Other | Sham filter |
Primary outcome
Asthma symptoms
Time frame: ACQ will be measured weekly for 6 consecutive weeks, two pre-intervention weeks (before box fans have been given to participant) and four weeks while fans are being used in the home. Symptoms will also be assessed at the six month follow-up visit.
Symptoms are evaluated with the seven-item asthma control questionnaire (ACQ), a validated tool used in children.
FEV1
Time frame: FEV1 measures will be taken daily, once in the morning and once at night for the six week study time frame. Prior to the six month follow up we will ask participants to take three consecutive days of FEV1 measurements, for an additional 6 measures
FEV1 is captured with a digital peak flow meter.
3 secondary outcomes
Asthma quality of life
Time frame: Will be evaluated at baseline (visit 1), after 6 weeks (visit 3) and at 6 month follow up (visit 4)
Use of rescue medications
Time frame: ACQ will be measured weekly for 6 consecutive weeks, two pre-intervention weeks (before box fans have been given to participant) and four weeks while fans are being used in the home. Symptoms will also be assessed at the six month follow-up visit.
Health care utilization in the past month
Time frame: Will be evaluated at baseline (visit 1), after 6 weeks (visit 3) and at 6 month follow up (visit 4)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
- Individual participant dataSharing planned: Yes. Only de-identified individual level data sets will be shared. Given the small sample size of our study, we will protect against deductive disclosure by withholding information that could result in disclosure. We will also require interested investigators to provide a proposal that will outline their study question and analytic methods. If there is any overlap with ongoing manuscripts, we will ask investigators to collaborate with ongoing efforts or to propose an alternative study question. Investigators will be required to sign a data sharing agreement that will include assurances about participant privacy and data confidentiality. We do not anticipate a great number of requests for our data so will handle them on an individual basis. After discussing the data with investigators who are interested in accessing it, we will share it via a secure site.
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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.
Anjum Hajat, PhD, MPH principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MERV 13 filter in people with Asthma in Children, run by University of Washington 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 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: looking for participants now, as of the sponsor's last update on 13 Aug 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anjum Hajat, PhD, MPH (206-685-3618, anjumh@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asthma symptoms (time frame: ACQ will be measured weekly for 6 consecutive weeks, two pre-intervention weeks (before box fans have been given to participant) and four weeks while fans are being used in the home. Symptoms will also be assessed at the six month follow-up visit.). The study lists 2 primary outcomes in all. 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 13 Aug 2024.