Air Filtration for COPD

Overseen By Insung Kang, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Illinois Institute of Technology

Disqualifiers: Home palliative care, Life expectancy <6 months, Hazardous conditions, others

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 52 weeks

80 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Air cleaner, Air Purifier, HEPA Filter, Activated Carbon Filter, Indoor Air Cleaner for COPD?

Research shows that using portable air cleaners with HEPA and carbon filters can reduce respiratory symptoms and the need for rescue medication in people with COPD, especially those who spend more time indoors and use the air cleaners consistently. ^{1 2 3 4 5}

Is using an air cleaner safe for people with COPD?

Research shows that using air cleaners, like HEPA filters, is generally safe for people with COPD and can even help improve respiratory symptoms and reduce the need for medication. ^{1 3 6 7 8}

How is the air cleaner treatment for COPD different from other treatments?

The air cleaner treatment for COPD is unique because it focuses on removing harmful particles and gases from the air, which are major causes of COPD, rather than using medications or invasive procedures. This approach aims to address the root cause of the condition by improving indoor air quality, which is different from traditional treatments that primarily manage symptoms. ^{9 10 11 12 13}

What is the purpose of this trial?

The goal of this study is to investigate the effectiveness of stand-alone air filtration for improving indoor air quality (IAQ) and chronic obstructive pulmonary disease (COPD) outcomes in a high-risk urban cohort of 80 U.S. military veterans with COPD. Secondary goals of the study are to (1) investigate housing-related factors that may contribute to COPD exacerbation, (2) investigate the utility of using low-cost sensors for indoor air pollution epidemiology studies and for providing actionable or useful information on the quality of their indoor air to patients and their physicians, and (3) evaluate the costs and benefits of using stand-alone air filtration to improve IAQ and COPD outcomes.

Research Team

Kaveeta Jagota

Principal Investigator

Jesse Brown VA Medical Center

Israel Rubinstein, MD

Principal Investigator

Jesse Brown VA Medical Center

Mohammad Heidarinejad, PhD

Principal Investigator

Illinois Institute of Technology

Zane Elfessi, PharmD

Principal Investigator

Jesse Brown VA Medical Center

Eligibility Criteria

This trial is for U.S. military veterans aged 18 and older who have COPD, live in Chicago, can consent, speak English, have stable housing for over 6 months, can communicate by phone, are fully vaccinated against COVID-19 and receive care at JBVAMC. Those with a life expectancy under 6 months or hazardous home conditions cannot join.

Inclusion Criteria

English speaking and writing

Able to provide consent

Chicago resident

Exclusion Criteria

Concomitant operation of a non-study air cleaner and alike by a participant in his/her current residence at any time during the course of the trial constitutes protocol violation leading to disqualification of said participant from the study

I am receiving care at home to manage my symptoms.

People who already have an air purifier or similar device in their home will not be included in the screening.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Housing condition assessments and baseline measurements of indoor and outdoor air quality and environmental conditions

4 weeks

1 visit (in-person)

Treatment

Participants receive either a functioning air cleaner with HEPA filter or a placebo unit for approximately 1 year

52 weeks

Regular monitoring visits (in-person and virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including clinical outcomes and quality of life assessments

4 weeks

Treatment Details

Interventions

• Air cleaner

Trial Overview The study tests if stand-alone air filters improve indoor air quality and health outcomes for veterans with COPD. It also examines housing factors affecting COPD exacerbation, the use of low-cost sensors to monitor indoor pollution, and the cost-effectiveness of using air filters.

Participant Groups

Group I: Intervention Active Control 1 Intervention

an air cleaner with HEPA and carbon filter installed

Group II: Placebo Placebo Group 1 Intervention

an air cleaner with the primary filter removed

Air cleaner is already approved in United States, European Union for the following indications:

Approved in United States as Air Cleaner for:

• Improving indoor air quality for COPD patients
• Reducing COPD exacerbation risk
• Improving quality of life and functional status

Approved in European Union as Air Purifier for:

• Relieving symptoms of COPD
• Improving heart health in COPD patients
• Reducing indoor air pollution

Who Is Running the Clinical Trial?

Illinois Institute of Technology

Lead Sponsor

Trials

26

Recruited

15,300+

Elevate

Collaborator

Trials

2

Recruited

130+

Jesse Brown VA Medical Center

Collaborator

Trials

8

Recruited

1,900+

US Department of Housing and Urban Development

Collaborator

Trials

8

Recruited

5,800+

Findings from Research

The use of active portable high-efficiency particulate air cleaners showed a significant reduction in respiratory symptoms and moderate exacerbations in former smokers with COPD over a 6-month period, indicating potential health benefits from reducing indoor particulate matter.

Participants who adhered to using the air cleaners and spent more time indoors experienced greater improvements in their respiratory health, suggesting that these devices could be particularly effective for individuals with COPD in indoor environments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized Clinical Trial of Air Cleaners to Improve Indoor Air Quality and Chronic Obstructive Pulmonary Disease Health: Results of the CLEAN AIR Study. Hansel, NN., Putcha, N., Woo, H., et al.[2023]

In a 6-month study involving 116 former smokers with COPD, 76.1% of participants adhered to using portable air cleaners at least 80% of the time, which could potentially improve their respiratory health by reducing indoor pollutants.

Factors such as higher household income and using electric heating were linked to better adherence, while lower quality of life and recent exacerbations were associated with lower adherence, indicating that socioeconomic and health status play crucial roles in the effectiveness of air cleaner interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patterns and Predictors of Air Cleaner Adherence Among Adults with COPD. Lorizio, W., Woo, H., McCormack, MC., et al.[2022]

Individuals with chronic obstructive pulmonary disease (COPD) are particularly sensitive to ambient air pollution particles, despite being exposed to much higher levels of particles from smoking, which raises concerns about their health.

The U.S. Environmental Protection Agency has included particulate matter levels in its air quality index to help raise awareness and discourage exposure to elevated levels of air pollution for vulnerable populations like those with COPD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ambient air pollution particles and the acute exacerbation of chronic obstructive pulmonary disease. Sint, T., Donohue, JF., Ghio, AJ.[2019]

In a study involving 225 children aged 6 to 12 with asthma exposed to secondhand smoke, the use of HEPA air cleaners resulted in 42 fewer unscheduled asthma visits, indicating a significant reduction in asthma-related emergencies (P = .043).

The intervention group experienced a 25% reduction in airborne particles, while the control group only saw a 5% reduction, suggesting that HEPA air cleaners effectively lower harmful particulate levels, although no significant differences were found in reported asthma symptoms or other biomarkers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of HEPA air cleaners on unscheduled asthma visits and asthma symptoms for children exposed to secondhand tobacco smoke. Lanphear, BP., Hornung, RW., Khoury, J., et al.[2021]

In a study involving nine patients allergic to house dust mites, an air-cleaning device with a HEPA filter did not significantly reduce indoor levels of Dermatophagoides sp. allergens or improve symptoms related to bronchial hyperresponsiveness and rhinitis over a 2-month period.

Although the mean level of allergens decreased spontaneously during the study, the air-cleaner alone was found to be insufficient as a substitute for standard avoidance measures for managing mite allergies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of an air-cleaning device equipped with a high efficiency particulate air filter in house dust mite respiratory allergy. Antonicelli, L., Bilò, MB., Pucci, S., et al.[2021]

Chronic obstructive pulmonary disease (COPD) is a major health issue, currently the fourth leading cause of death globally, with expected increases in prevalence and mortality in the coming decades.

The commonly used 'fixed ratio' method for diagnosing COPD (FEV1/FVC < 0.7) may lead to misclassification of patients and oversimplification of the disease's complex nature, suggesting a need for more nuanced diagnostic approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chronic obstructive pulmonary disease diagnosis: the simpler the better? Not always. Di Marco, F., Tantucci, C., Pellegrino, G., et al.[2022]

References

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

Randomized Clinical Trial of Air Cleaners to Improve Indoor Air Quality and Chronic Obstructive Pulmonary Disease Health: Results of the CLEAN AIR Study. [2023]

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

Exposure time and place: do COPD patients differ from the general population? [2022]

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

Patterns and Predictors of Air Cleaner Adherence Among Adults with COPD. [2022]

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

In former smokers with COPD, HEPA and carbon filter air cleaners improved moderate exacerbations but not QoL. [2022]

5. Australia pubmed.ncbi.nlm.nih.gov

Air pollution and chronic obstructive pulmonary disease. [2012]

6. England pubmed.ncbi.nlm.nih.gov

Ambient air pollution particles and the acute exacerbation of chronic obstructive pulmonary disease. [2019]

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

Effects of HEPA air cleaners on unscheduled asthma visits and asthma symptoms for children exposed to secondhand tobacco smoke. [2021]

8. Denmark pubmed.ncbi.nlm.nih.gov

Efficacy of an air-cleaning device equipped with a high efficiency particulate air filter in house dust mite respiratory allergy. [2021]

9. Czech Republic pubmed.ncbi.nlm.nih.gov

[Treatment of stabilized chronic obstructive pulmonary disease]. [2006]

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

Chronic obstructive pulmonary disease. [2019]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Chronic obstructive pulmonary disease diagnosis: the simpler the better? Not always. [2022]

12. New Zealand pubmed.ncbi.nlm.nih.gov

Efficacy and safety of eco-friendly inhalers: focus on combination ipratropium bromide and albuterol in chronic obstructive pulmonary disease. [2021]

13. England pubmed.ncbi.nlm.nih.gov

Proteome analysis of urinary biomarkers in a cigarette smoke-induced COPD rat model. [2023]