AsthmaAIRENCT01869543
Asthma and Indoor-air: Reducing Exposures
A study testing Stand Alone Air Cleaner and HVAC Modification in people with Asthma, run by University of California, Davis at 1 site in United States.
Trial summary
Two hundred moderate to severely asthmatic children (6-12 years) will be enrolled in a study to look at the effectiveness of high efficiency filtration of indoor air in homes on reducing asthma symptoms. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Asthma
- What is being tested?
- Stand Alone Air Cleaner and HVAC Modification
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 219 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to 8 Feb 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 6-12 years of age
- Living in Fresno, San Bernardino or Riverside Counties.
- Physician diagnosed asthma, as stated by the participant's caregiver.
- In the last six months, the child must have had asthma symptoms at least twice a week for several weeks in a row.
Who cannot join
- Children living in homes where more than 2 cigarettes are smoked per week in the home.
- Children that spend 2 or more nights per week in another home.
- Children living in homes that are planning on moving in the next 2 years.
- Children living in homes that keep their windows open most of the time.
- Children living in homes that have existing high efficiency filtration.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Davis- Department of Public Health Sciences
Davis, California, 95616
About this study
Official title: Benefits of High Efficiency Filtration to Children With Asthma
Two hundred moderate to severely asthmatic children (6-12 years) will be enrolled in a study to look at the effectiveness of high efficiency filtration of indoor air in homes on reducing asthma symptoms. One intervention group will have high efficiency filters or filtration systems installed in their central heating and air conditioning (HVAC) system. The second intervention group will have high efficiency portable air cleaners placed in the child's bedroom and in the main living area. Each participant will receive true air filtration for a year and a placebo for a year. During the placebo period a sham filter will be used that removes very little of the particles. Measures of health effects will include days of symptoms, unplanned utilization of the healthcare system for asthma-related illness, short-term medication use, peak exhaled flow, spirometry, and exhaled nitric oxide (eNO).
- Conditions
- Asthma
- Being tested
- Stand Alone Air Cleaner, HVAC Modification
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stand Alone Air CleanerOther
This is an environmental intervention using a stand alone air cleaner designed to reduce the air pollution levels in the home.
HVAC ModificationOther
This is an environmental intervention that modifies the home HVAC system to include high efficiency air filtration designed to reduce the air pollution levels in the home.
| Study group | Role | What they receive |
|---|---|---|
| Stand Alone Air Cleaner-True/Sham | Experimental | The participant will have stand alone air cleaners placed in their home. They will have true filtration followed by sham filtration. Receives: Other: Stand Alone Air Cleaner |
| Stand Alone Air Cleaner-Sham/True | Experimental | Participants will have stand alone air cleaners placed in their homes. They will begin with sham filtration. Receives: Other: Stand Alone Air Cleaner |
| HVAC modification-True/Sham | Experimental | Participants will have their HVAC system modified to include high efficiency filtration. They will begin true filtration followed by sham filtration. Receives: Other: HVAC Modification |
| HVAC Modification-Sham/True | Experimental | Participants will have their HVAC system modified to include high efficiency filtration. They will begin sham filtration. Receives: Other: HVAC Modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days with asthma symptoms
The maximum number of days with symptoms, from a two-week recall period, will be determined every three months. The maximum number of days with symptoms will be defined as the largest value among the following three variables: (i) number of days with wheezing, tightness in the chest, or cough because of asthma, (ii) number of days that the child had to slow down or stop his/her play or activities because of asthma, wheezing or tightness in the chest, or cough, or (iii) number of nights that the child woke up because of asthma, wheezing or tightness in the chest, or cough.
The seasonally adjusted mean difference in the number of symptom days between the true and sham filtration periods will be estimated using generalized linear mixed-effects regression models.
Measured: Measured at 3, 6, 9, 12, 15, 18, 21, and 24 months
Secondary outcomes (13)
Forced expiratory volume at one second, percent predicted (FEV1 % predicted)
Lung function will be assessed using FEV1 % predicted. The adjusted mean difference in the FEV1% predicted between the true and sham filtration periods will be estimated using generalized linear mixed-effects regression models.
Measured: Measured at 12 months and 24 months
Forced vital capacity, percent predicted (FVC % predicted)
Lung function will be assessed using FVC % predicted. The adjusted mean difference in the FVC% predicted between the true and sham filtration periods will be estimated using generalized linear mixed-effects regression models.
Measured: Measured at 12 months and 24 months
Peak Expiratory Flow Rate (PEFR)
Lung function will be assessed using morning peak expiratory flow rate (PEFR), averaged for all days over one-week testing periods. The seasonally adjusted mean difference in the PERF measure between the true and sham filtration periods will be estimated using generalized linear mixed-effects regression models.
Measured: Measured at 3, 6, 9, 12, 15, 18, 21, and 24 months
Exhaled NO
The seasonally adjusted mean difference in the Exhaled NO between the true and sham filtration periods will be estimated using generalized linear mixed-effects regression models.
Measured: Measure at 6, 12, 18, and 24 months
Days of missing school due to asthma
Days of missing school due to asthma will be expressed as a proportion of days of missing school versus the total number of school days during a two-week period. The seasonally adjusted mean difference in the proportion of missed school days between the true and sham filtration periods will be estimated using generalized linear mixed-effects regression models.
Measured: Measured at 3, 6, 9, 12, 15, 18, 21, and 24 months
Days of missing work for parents due to child's asthma
Days of missing work due to child's asthma will be expressed as a proportion of days of missing work versus the total number of work days during a two-week period. The seasonally adjusted mean difference in the proportion of missed work days between the true and sham filtration periods will be estimated using generalized linear mixed-effects regression models.
Measured: Measured at 3, 6, 9, 12, 15, 18, 21, and 24 months
Hospitalizations
The number of overnight hospitalizations due to asthma will be assessed every 3 months during real and sham periods. Participants will report number of overnight hospitalizations due to asthma that occurred in the previous three months. The adjusted mean hospitalization incidence ratio between the true and sham filtration periods will be compared using mixed-effects Poison regression models.
Measured: Count during 1-year true filtration period and count during 1-year sham filtration period
Emergency Room Visits
The number of emergency room visits due to asthma will be assessed every 3 months during real and sham periods. Participants will report number of emergency room visits due to asthma that occurred in the previous three months. The adjusted mean emergency room visit incidence ratio between the true and sham filtration periods will be compared using generalized mixed-effects regression models.
Measured: Count during 1-year true filtration period and count during 1-year sham filtration period
Unplanned Clinic Visits
The number of unplanned clinic visits due to asthma will be assessed every 3 months during real and sham periods. Participants will report number of unplanned clinic visits due to asthma that occurred in the previous three months. The adjusted mean unplanned clinic visit incidence ratio between the true and sham filtration periods will be compared using generalized mixed-effects regression models.
Measured: Count during 1-year true filtration period and count during 1-year sham filtration period
Unplanned Steroid treatments
The number of unplanned steroid treatments due to asthma will be assessed every 3 months during real and sham periods. Participants will report number of unplanned steroid treatments due to asthma that occurred in the previous three months. The adjusted mean unplanned steroid treatment incidence ratio between the true and sham filtration periods will be compared using generalized mixed-effects regression models.
Measured: Count during 1-year true filtration period and count during 1-year sham filtration period
Mini Pediatric Asthma Quality of Life Questionnaire (MiniPAQLQ)
The MiniPAQLQ has three composite domains, symptoms, emotional function, and activity limitation, each of which will be analyzed separately. The seasonally adjusted mean difference in each domain score between the true and sham filtration periods will be estimated using generalized linear mixed-effects regression models.
Measured: Measured at 3, 6, 9, 12, 15, 18, 21, and 24 months
Allergy symptoms
Allergy symptoms during two week recall periods will be summarized into a composite score. The seasonally adjusted mean difference in the scores between the true and sham filtration periods will be using generalized linear mixed-effects regression models.
Measured: Measured at 3, 6, 9, 12, 15, 18, 21, and 24 months
Respiratory disease
The number of incidents of respiratory disease will be assessed every 3 months during real and sham periods. Participants will report number of incidents of respiratory disease that occurred in the previous three months. The adjusted mean respiratory disease incidence ratio between the true and sham filtration periods will be compared using generalized mixed-effects regression models.
Measured: Count of incidents of respiratory disease during 1-year true filtration period and count during 1-year sham filtration period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2013 (estimated)
- Study startJul 2012
- Primary completion8 Feb 2017
- Study completion8 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 219 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Deborah Bennett, PhD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01869543
- Sponsor's protocol ID
- 346123
- Other IDs
- 11-324
- Acronym
- AIRE
- Status last verified
- Mar 2019
- First submitted
- 3 Apr 2013
- Last updated
- 21 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefits of High Efficiency Filtration to Children With Asthma
- ClinicalTrials.gov ID
- NCT01869543
- Acronym / sponsor ID
- AIRE / 346123
- Conditions
- Asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 219 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- Jul 2012 (actual)
- Primary completion
- 8 Feb 2017 (actual)
- Study completion
- 8 Feb 2017 (actual)
- First posted
- 5 Jun 2013 (estimated)
- 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.
Two hundred moderate to severely asthmatic children (6-12 years) will be enrolled in a study to look at the effectiveness of high efficiency filtration of indoor air in homes on reducing asthma symptoms. One intervention group will have high efficiency filters or filtration systems installed in their central heating and air conditioning (HVAC) system. The second intervention group will have high efficiency portable air cleaners placed in the child's bedroom and in the main living area. Each participant will receive true air filtration for a year and a placebo for a year. During the placebo period a sham filter will be used that removes very little of the particles. Measures of health effects will include days of symptoms, unplanned utilization of the healthcare system for asthma-related illness, short-term medication use, peak exhaled flow, spirometry, and exhaled nitric oxide (eNO).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Stand Alone Air Cleaner-True/Sham | Experimental | Other: Stand Alone Air CleanerThe participant will have stand alone air cleaners placed in their home. They will have true filtration followed by sham filtration. |
| Stand Alone Air Cleaner-Sham/True | Experimental | Other: Stand Alone Air CleanerParticipants will have stand alone air cleaners placed in their homes. They will begin with sham filtration. |
| HVAC modification-True/Sham | Experimental | Other: HVAC ModificationParticipants will have their HVAC system modified to include high efficiency filtration. They will begin true filtration followed by sham filtration. |
| HVAC Modification-Sham/True | Experimental | Other: HVAC ModificationParticipants will have their HVAC system modified to include high efficiency filtration. They will begin sham filtration. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 6-12 years of age
- Living in Fresno, San Bernardino or Riverside Counties.
- Physician diagnosed asthma, as stated by the participant's caregiver.
- In the last six months, the child must have had asthma symptoms at least twice a week for several weeks in a row.
Key exclusion criteria (5 listed)
- Children living in homes where more than 2 cigarettes are smoked per week in the home.
- Children that spend 2 or more nights per week in another home.
- Children living in homes that are planning on moving in the next 2 years.
- Children living in homes that keep their windows open most of the time.
- Children living in homes that have existing high efficiency filtration.
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 |
|---|---|---|
| Stand Alone Air CleanerThis is an environmental intervention using a stand alone air cleaner designed to reduce the air pollution levels in the home. | Other | Stand Alone Air Cleaner-Sham/True, Stand Alone Air Cleaner-True/Sham |
| HVAC ModificationThis is an environmental intervention that modifies the home HVAC system to include high efficiency air filtration designed to reduce the air pollution levels in the home. | Other | HVAC Modification-Sham/True, HVAC modification-True/Sham |
Primary outcome
Days with asthma symptoms
Time frame: Measured at 3, 6, 9, 12, 15, 18, 21, and 24 months
The maximum number of days with symptoms, from a two-week recall period, will be determined every three months. The maximum number of days with symptoms will be defined as the largest value among the following three variables: (i) number of days with wheezing, tightness in the chest, or cough because of asthma, (ii) number of days that the child had to slow down or stop his/her play or activities because of asthma, wheezing or tightness in the chest, or cough, or (iii) number of nights that the child woke up because of asthma, wheezing or tightness in the chest, or cough. The seasonally adjusted mean difference in the number of symptom days between the true and sham filtration periods will be estimated using generalized linear mixed-effects regression models.
13 secondary outcomes
Forced expiratory volume at one second, percent predicted (FEV1 % predicted)
Time frame: Measured at 12 months and 24 months
Forced vital capacity, percent predicted (FVC % predicted)
Time frame: Measured at 12 months and 24 months
Peak Expiratory Flow Rate (PEFR)
Time frame: Measured at 3, 6, 9, 12, 15, 18, 21, and 24 months
Exhaled NO
Time frame: Measure at 6, 12, 18, and 24 months
Days of missing school due to asthma
Time frame: Measured at 3, 6, 9, 12, 15, 18, 21, and 24 months
Days of missing work for parents due to child's asthma
Time frame: Measured at 3, 6, 9, 12, 15, 18, 21, and 24 months
Hospitalizations
Time frame: Count during 1-year true filtration period and count during 1-year sham filtration period
Emergency Room Visits
Time frame: Count during 1-year true filtration period and count during 1-year sham filtration period
Unplanned Clinic Visits
Time frame: Count during 1-year true filtration period and count during 1-year sham filtration period
Unplanned Steroid treatments
Time frame: Count during 1-year true filtration period and count during 1-year sham filtration period
Mini Pediatric Asthma Quality of Life Questionnaire (MiniPAQLQ)
Time frame: Measured at 3, 6, 9, 12, 15, 18, 21, and 24 months
Allergy symptoms
Time frame: Measured at 3, 6, 9, 12, 15, 18, 21, and 24 months
Respiratory disease
Time frame: Count of incidents of respiratory disease during 1-year true filtration period and count during 1-year sham filtration period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2019.
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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.
Deborah Bennett, PhD principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stand Alone Air Cleaner and HVAC Modification in people with Asthma, run by University of California, Davis 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 4 inclusion and 5 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 21 Mar 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Days with asthma symptoms (time frame: Measured at 3, 6, 9, 12, 15, 18, 21, and 24 months). 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 21 Mar 2019; AzTrials last refreshed its copy on 30 Oct 2026.