Air Filters for Childhood Asthma

(DAISY Trial)

Overseen By Anjum Hajat, PhD, MPH

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Washington

Disqualifiers: Unstable housing, Shared custody

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 4 weeks

80 Participants Needed

Trial Summary

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems likely that you can continue your asthma medications, but it's best to confirm with the trial organizers.

What data supports the effectiveness of the air filter treatment for childhood asthma?

A study on a portable air-flow filter showed improvement in asthma symptoms for children, suggesting that using air filters to reduce indoor irritants can be beneficial for managing asthma. ^{1 2 3 4 5}

Is it safe for children with asthma to use air filters?

There is no specific safety data on air filters for childhood asthma in the provided research articles, but minimizing exposure to allergens, which air filters can help with, is generally considered safe and beneficial for managing asthma. ^{6 7 8 9 10}

How does the MERV 13 filter treatment for childhood asthma differ from other treatments?

The MERV 13 filter treatment is unique because it focuses on improving indoor air quality by reducing particulate matter, which can trigger asthma symptoms, rather than using medication. This approach aims to minimize exposure to environmental allergens, potentially reducing the need for asthma medication and its side effects. ^{7 11 12 13 14}

What is the purpose of this trial?

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

Research Team

Anjum Hajat, PhD, MPH

Principal Investigator

University of Washington

Eligibility Criteria

This trial is for children aged 6-17 with asthma in the Duwamish Valley. They must be able to fill out questionnaires, use a peak flow meter, and have an air monitor at home. Details on specific inclusion or exclusion criteria are not provided.

Inclusion Criteria

I am between 6 and 17 years old.

My asthma symptoms have been frequent and severe recently.

Living in Georgetown and South Park neighborhoods of Seattle

Exclusion Criteria

Children with unstable housing or shared custody arrangements

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-intervention

Participants complete baseline assessments and two weeks of pre-intervention monitoring

2 weeks

1 visit (in-person)

Treatment

Participants use box fans with either sham or MERV 13 filters for four weeks

4 weeks

Weekly monitoring (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

1 visit (in-person)

Treatment Details

Interventions

• MERV 13 filter
• Sham filter

Trial Overview The study tests if box fans with MERV 13 filters versus sham (fake) filters can lessen asthma symptoms and improve lung function (FEV1) in asthmatic children by comparing indoor air quality and health outcomes between the two groups.

Participant Groups

Group I: Sham filter Experimental Treatment 1 Intervention

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.

Group II: MERV 13 filter Experimental Treatment 1 Intervention

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.

MERV 13 filter is already approved in United States for the following indications:

Approved in United States as MERV 13 filter for:

• Improving indoor air quality
• Reducing asthma symptoms

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

National Institute of Environmental Health Sciences (NIEHS)

Collaborator

Trials

294

Recruited

1,233,000+

Findings from Research

In a study involving 13 asthmatic children, the use of a portable laminar air-flow filter (Enviracaire) led to a statistical improvement in asthma symptom scores, indicating potential benefits for managing asthma symptoms indoors.

Despite the improvement in symptom scores, there was no significant change in peak flow measurements, suggesting that while the filter may help reduce symptoms, it may not directly enhance lung function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of laminar air flow portable filter in asthmatic children. Villaveces, JW., Rosengren, H., Evans, J.[2007]

Inhaled corticosteroids are the most effective treatment for controlling airway inflammation in children with persistent asthma, despite concerns about potential growth suppression.

Leukotriene receptor antagonists and long-acting beta2-agonists can help reduce the required doses of inhaled corticosteroids, and allergen immunotherapy is gaining recognition as an important treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevention of asthma morbidity: recent advances. Zorc, JJ., Pawlowski, NA.[2019]

A three-month asthma education program for 30 children and their parents significantly improved asthma control, leading to fewer daytime symptoms, night awakenings, and reduced reliance on rescue inhalers.

The program also resulted in a notable decrease in emergency department visits and hospitalizations, along with enhanced lung function and quality of life for the participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Asthma education and its impact on pediatric asthma severity: a prospective cohort study. Omara, HA., Mansour, MG., Badr, RM.[2023]

A study involving 40 children with moderate to severe asthma showed significant improvements in their peak flow meter (PFM) and metered-dose inhaler (MDI) techniques after attending an asthma camp, with PFM scores increasing from 6.0 to 8.9 and MDI scores from 4.1 to 6.5.

The camp led to a dramatic reduction in health care utilization, including a 59% decrease in emergency room visits and an 83% decrease in hospitalizations, along with a reduction in school absenteeism, resulting in an average health care savings of $2014 per child.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes analysis of a summer asthma camp. Kelly, CS., Shield, SW., Gowen, MA., et al.[2019]

The meta-analysis of asthma drug therapy trials revealed a small but measurable placebo effect in stable asthmatic patients, with a mean increase in forced expiratory volume in 1 second (FEV1) of 0.11 L/min and a 4.81% increase, indicating that some patients may experience improvements even without active treatment.

Interestingly, while the placebo group showed a slight increase in FEV1, they experienced a decrease in peak expiratory flow (PEF) by 2.24 L/min, suggesting that different measures of lung function can respond differently to placebo, highlighting the complexity of asthma treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The placebo effect in asthma drug therapy trials: a meta-analysis. Joyce, DP., Jackevicius, C., Chapman, KR., et al.[2019]

Children with asthma participating in placebo-controlled trials (PCTs) experienced higher rates of withdrawal due to asthma exacerbations (9.4%) compared to other trials (3.1%), indicating potential harm from not receiving necessary anti-inflammatory medications.

The study highlights that many PCTs did not require adequate treatment for children with more than mild asthma, exposing them to unnecessary risks without providing specific benefits or analyses for this age group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ethical assessment of clinical asthma trials including children subjects. Coffey, MJ., Wilfond, B., Ross, LF.[2019]

Anti-asthma medications alone are insufficient for effective asthma management, as they do not significantly reduce asthma mortality and can cause side effects.

Minimizing exposure to environmental allergens, such as house dust mites and cockroach allergens, is crucial in managing asthma, especially in children, as it can reduce the severity of attacks and the need for medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The non-drug treatment of asthma. Liang, AY.[2015]

Asthma treatment in children should be flexible and adjusted every 3 to 6 months based on clinical and functional control, allowing for a step down in therapy when the condition is stable.

If asthma control is poor, it is crucial to assess treatment compliance and identify aggravating factors, with the primary strategy being to increase inhaled corticosteroid dosage and consider adding other medications like long-acting beta 2 agonists or leukotriene antagonists.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[When and how to modify the management of asthma in children over the age of 4]. de Blic, J., Deschildre, A., Pin, I., et al.[2019]

Children have the highest rates of asthma, with nearly 5 million outpatient visits for asthma treatment in the U.S. in 2001, highlighting the need for effective therapies tailored for this age group.

Recent advancements in asthma treatments for children include new inhaled corticosteroids, long-acting beta2-agonists, leukotriene-receptor blockers, and a short-acting beta2-agonist, which could improve patient outcomes and reduce healthcare burdens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advances in the management of pediatric asthma: a review of recent FDA drug approvals and label updates. Kemp, JP.[2006]

In treating childhood asthma, it's crucial to balance the effectiveness of medications like albuterol (a fast-acting bronchodilator) and inhaled corticosteroids with their potential side effects, as children may experience adverse events more severely than adults.

Inhaled corticosteroids are recommended as effective and well-tolerated first-line treatments, while other bronchodilators and anti-inflammatory agents can be used as needed, always considering the risk versus benefit of each medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of bronchodilator therapy in pediatric asthma patients. Selcow, JE.[2005]

In a study involving 126 low-income households with children suffering from asthma, the use of free-standing HEPA filters significantly reduced particulate matter (PM) levels in bedrooms by an average of 50%, demonstrating their effectiveness in improving indoor air quality.

However, the effectiveness of these filters was highly dependent on how consistently they were used by the households, with usage declining over time, indicating that strategies to encourage ongoing use are essential for maximizing their benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Particulate matter concentrations in residences: an intervention study evaluating stand-alone filters and air conditioners. Batterman, S., Du, L., Mentz, G., et al.[2022]

In a study of 24 dust mite-sensitive asthmatic children, using Allergy Control Covers (ACC) significantly reduced dust mite allergen levels in mattresses after 1 and 2 months, while HEPA filters and control groups showed no decrease.

Only the ACC group demonstrated significant improvements in lung function (FEV1) and reduced peak expiratory flow rates after 4 months, indicating that while ACC may help with asthma control, the benefits may not be long-lasting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An evaluation of mattress encasings and high efficiency particulate filters on asthma control in the tropics. Thiam, DG., Tim, CF., Hoon, LS., et al.[2016]

In a study involving 89 households with children suffering from asthma, HEPA air filters were used significantly more during intensive monitoring periods (70% usage) compared to non-intensive periods (34% usage), indicating that active engagement is crucial for maintaining filter use.

Despite participants recognizing the benefits of HEPA filters for respiratory health, actual usage dropped significantly when not monitored, suggesting that simply providing filters is not enough; ongoing support and evaluation are necessary to ensure effective use and accurate assessment of health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Free-standing Filters in an Asthma Intervention Study. Batterman, S., Du, L., Parker, E., et al.[2021]

In a study involving 12 young asthmatics allergic to house dust, the use of dust control measures, including electrostatic and high-efficiency particulate air filters, did not lead to significant improvements in asthma symptoms or peak expiratory flow rates.

The findings suggest that house dust suppression may not provide additional benefits for managing asthma in patients who are already well-controlled, indicating that other treatment strategies may be more effective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

House dust control and asthma: a placebo-control trial of cleaning air filtration. Bowler, SD., Mitchell, CA., Miles, J.[2006]

References

1. United States pubmed.ncbi.nlm.nih.gov

Use of laminar air flow portable filter in asthmatic children. [2007]

2. United States pubmed.ncbi.nlm.nih.gov

Prevention of asthma morbidity: recent advances. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Asthma education and its impact on pediatric asthma severity: a prospective cohort study. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Outcomes analysis of a summer asthma camp. [2019]

5. England pubmed.ncbi.nlm.nih.gov

The placebo effect in asthma drug therapy trials: a meta-analysis. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Ethical assessment of clinical asthma trials including children subjects. [2019]

7. China (Republic : 1949- ) pubmed.ncbi.nlm.nih.gov

The non-drug treatment of asthma. [2015]

8. France pubmed.ncbi.nlm.nih.gov

[When and how to modify the management of asthma in children over the age of 4]. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Advances in the management of pediatric asthma: a review of recent FDA drug approvals and label updates. [2006]

10. United States pubmed.ncbi.nlm.nih.gov

Safety of bronchodilator therapy in pediatric asthma patients. [2005]

11. England pubmed.ncbi.nlm.nih.gov

Particulate matter concentrations in residences: an intervention study evaluating stand-alone filters and air conditioners. [2022]

12. Thailand pubmed.ncbi.nlm.nih.gov

An evaluation of mattress encasings and high efficiency particulate filters on asthma control in the tropics. [2016]

13. Netherlands pubmed.ncbi.nlm.nih.gov

Use of Free-standing Filters in an Asthma Intervention Study. [2021]

14. United States pubmed.ncbi.nlm.nih.gov

House dust control and asthma: a placebo-control trial of cleaning air filtration. [2006]