Air Cleaner for COPD

(Clean Air Trial)

Recruiting at 10 trial locations

Overseen By Alejandro Comellas, MD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: JHSPH Center for Clinical Trials

Disqualifiers: Other lung diseases, Metastatic cancer, Pregnancy, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

770 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether air cleaners can assist people with COPD, a chronic lung disease that makes breathing difficult, by improving indoor air quality. Researchers aim to determine if these air cleaners can reduce COPD flare-ups, enhance quality of life, and decrease the need for rescue medications. Participants in one group will use active air cleaners that filter out harmful particles and gases, while another group will use sham air cleaners that look and sound the same but don't filter. Ideal candidates for the trial are former smokers diagnosed with COPD who have experienced breathing difficulties or flare-ups in the past year. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment for COPD.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on using an air cleaner to improve COPD symptoms, so it's likely you can continue your current treatments, but you should confirm with the study team.

What prior data suggests that this air cleaner is safe for COPD patients?

Research shows that air cleaners with HEPA filters are generally safe for people. These devices clean indoor air by removing particles like dust and pollen, as well as harmful gases. This is especially beneficial for individuals with breathing problems such as COPD (chronic obstructive pulmonary disease).

Studies have found that portable air cleaners with HEPA filters can reduce indoor air pollution by 50–60%. This reduction has improved symptoms for those with breathing issues. Importantly, no reports of serious side effects have emerged from using these air cleaners, so they are considered safe.

For those considering joining a trial involving an air cleaner, evidence suggests it should be safe and might improve lung health by cleaning the air. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using air cleaners for COPD because they offer a non-drug approach to managing the condition. Unlike traditional treatments that often involve inhalers or medications to open airways or reduce inflammation, the air cleaners target environmental factors by removing harmful particles and gases like Nitrogen Dioxide from the air. This method could potentially provide relief by improving indoor air quality, which is crucial for individuals with COPD, without the side effects associated with medication. With HEPA and activated carbon filters, the air cleaners provide a proactive way to enhance breathing environments, which could be a game-changer for those living with COPD.

What evidence suggests that this air cleaner is effective for COPD?

This trial will compare the effects of an active air cleaner with a sham air cleaner on individuals with COPD. Studies have shown that air cleaners can significantly improve indoor air quality by reducing tiny particles by 50–60%. Research indicates that these particles worsen health in people with COPD, a lung disease that makes breathing difficult. By reducing these particles, air cleaners may help decrease COPD flare-ups and improve quality of life. Several studies, including those on asthma and COPD, have demonstrated that using air cleaners can lead to easier breathing and less need for medication. This suggests that air cleaners could help people with COPD breathe more easily and live more comfortably. ^{1 4 5 6 7}

Are You a Good Fit for This Trial?

This trial is for adults over 40 with COPD, a history of smoking, and recent severe breathing issues or hospital visits due to COPD. They must have confirmed airway obstruction and not be using an air cleaner at home. Excluded are those who can't handle the device, live elsewhere part of the year, lack internet access, have other lung diseases (except asthma), are in poor health with short life expectancy, or are pregnant.

Inclusion Criteria

I have severe breathing issues or had a major COPD flare-up in the last year.

My doctor has diagnosed me with COPD.

My lung function test shows I have airway obstruction.

Exclusion Criteria

I cannot bring a 15-pound air cleaner into my home by myself or with help.

Spends >2 months per year in location other than home; or plans to change residence in the next 12 months

Deemed by the study investigator to be unable to complete study protocol, including likely lack of internet connectivity

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either active or sham air cleaners to assess impact on COPD exacerbation risk and quality of life

12 months

Regular intervals throughout the year

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Air cleaner
• Sham air cleaner

Trial Overview The study tests if using an air cleaner at home can reduce flare-ups and improve life quality for people with COPD compared to a sham (fake) device. Participants will randomly receive either the real air cleaner or a sham version to see which is more effective.

How Is the Trial Designed?

Group I: Active air cleaner Experimental Treatment 1 Intervention

The active arm will receive two active air cleaners with high efficiency particulate air (HEPA) filters which remove particulate matter (PM), as well as activated carbon filters to remove Nitrogen Dioxide (NO2) and other trace gases.

Group II: Sham air cleaner Placebo Group 1 Intervention

The sham control treatment arm will receive two sham air cleaners that have the internal HEPA and carbon filters removed, but which will run normally, including similar noise, airflow, and overall appearance compared to active air cleaners, thus blinding participants to filter status.

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?

JHSPH Center for Clinical Trials

Lead Sponsor

Trials

14

Recruited

11,200+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

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 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]

Chronic Obstructive Pulmonary Disease (COPD) is a treatable condition characterized by airflow obstruction, and its management requires a collaborative approach among healthcare providers to ensure effective treatment and rehabilitation tailored to individual patient needs.

First-line treatment for COPD includes inhaled long-acting bronchodilators, with the addition of inhaled corticosteroids for patients with more severe symptoms, while long-term oxygen therapy and respiratory rehabilitation are crucial for improving quality of life and managing exacerbations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The clinical and integrated management of COPD. An official document of AIMAR (Interdisciplinary Association for Research in Lung Disease), AIPO (Italian Association of Hospital Pulmonologists), SIMER (Italian Society of Respiratory Medicine), SIMG (Italian Society of General Medicine). Bettoncelli, G., Blasi, F., Brusasco, V., et al.[2022]

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]

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]

The article DOI correction indicates that the original study by Donohue et al. was published in 2020, which may contain important findings related to COPD (Chronic Obstructive Pulmonary Disease).

However, without additional context or content from the original study, specific insights regarding safety, efficacy, or mechanisms of action cannot be extracted.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Erratum: The Effect of Baseline Rescue Medication Use on Efficacy and Safety of Nebulized Glycopyrrolate Treatment in Patients with COPD from the GOLDEN 3 and 4 Studies [Corrigendum]. [2020]

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]

In patients with COPD, inhaled corticosteroids like budesonide and fluticasone propionate can reduce the expression of bacterial recognition receptors on macrophages, which may explain the increased risk of pneumonia in these patients.

Budesonide was more effective than fluticasone in counteracting receptor reductions caused by bacterial exposure, suggesting that the choice of corticosteroid may influence pneumonia risk in COPD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bacterial regulation of macrophage bacterial recognition receptors in COPD are differentially modified by budesonide and fluticasone propionate. Provost, KA., Smith, M., Miller-Larsson, A., et al.[2020]

The article DOI correction indicates that the original study by Wang et al. was published in 2021, which may contain important findings related to COPD (Chronic Obstructive Pulmonary Disease).

However, without the content of the original study, specific insights regarding safety, efficacy, or mechanisms of action cannot be extracted.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Erratum: Aerobic Exercise Alleviates Inflammation, Oxidative Stress, and Apoptosis in Mice with Chronic Obstructive Pulmonary Disease [Corrigendum]. [2022]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8886948/

Randomized Clinical Trial of Air Cleaners to Improve ... Indoor particulate matter is associated with worse chronic obstructive pulmonary disease (COPD) outcomes. It remains unknown whether reductions of indoor ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05913765

Air Filtration for COPD in VA Population of Veterans The goal of this study is to investigate the effectiveness of stand-alone air filtration for improving indoor air quality (IAQ) and chronic obstructive ...

3. aaqr.org aaqr.org/articles/aaqr-23-08-oa-0202

Real-World Effectiveness of Portable Air Cleaners in ... PACs equipped with filters are generally inexpensive, practical, and known to reduce indoor PM2.5 levels by typically 50–60% in experimental interventions, ...

4. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-025-08880-0

Study protocol for a 1-year, randomized, single-blind, parallel ... This study seeks to evaluate the effectiveness of stand-alone air filtration for reducing residential indoor particulate matter concentrations and improving ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0091674924008613

Cleaning indoor air—what works for respiratory health Several studies, including those focused on asthma and chronic obstructive pulmonary disease, demonstrated improvement in symptoms and medication receipt with ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06376994

Multi-Center Clean Air Randomized Controlled Trial in COPD This is a multi-center randomized, sham-controlled clinical trial to determine the effectiveness of an air cleaner intervention aimed at improving indoor air ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12139193/

Study protocol for a 1-year, randomized, single-blind ... Exposure to air pollutants in indoor and outdoor air is associated with adverse chronic obstructive pulmonary disease (COPD) outcomes.