Air Cleaner for COPD

(Clean Air Trial)

Recruiting at 7 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

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. 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.

Is using an air cleaner safe for people with COPD?

Research on air cleaners, like HEPA filters, shows they are generally safe for use in homes. They have been studied in various conditions, including asthma and allergies, without significant safety concerns reported. ^{1 2 3 4 5}

How does the air cleaner treatment for COPD differ from other treatments?

The air cleaner treatment for COPD is unique because it focuses on improving indoor air quality by removing pollutants and allergens, which can help reduce respiratory symptoms, unlike traditional treatments that primarily involve medications like inhaled bronchodilators and corticosteroids. ^{6 7 8 9 10}

What is the purpose of this trial?

This is a multi-center randomized, sham-controlled clinical trial to determine the effectiveness of an air cleaner intervention aimed at improving indoor air quality on reducing COPD exacerbation risk and improving quality of life, functional status, rescue medication use.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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]

References

1. 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]

2. 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]

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

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

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

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

5. 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]

6. Italy 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). [2022]

7. New Zealand 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]

8. Netherlands pubmed.ncbi.nlm.nih.gov

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

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

Bacterial regulation of macrophage bacterial recognition receptors in COPD are differentially modified by budesonide and fluticasone propionate. [2020]

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

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