What side effects are associated with this type of intervention?

Common treatments for Chronic Obstructive Pulmonary Disease (COPD) include inhaled medications such as long-acting beta-agonists (LABAs), long-acting muscarinic antagonists (LAMAs), and inhaled corticosteroids (ICS). Combination therapies like umeclidinium plus vilanterol have been shown to improve lung function but can cause side effects such as dry mouth, respiratory infections, and, in some cases, cardiovascular events. Bronchopulmonary hygiene physical therapy can increase sputum production but does not significantly affect pulmonary function. Bronchoscopic treatments like endobronchial coils can lead to complications such as pneumonia and COPD exacerbations. While air purifiers with HEPA filters are being studied for their potential benefits in reducing airborne particles and allergens, specific side effects related to their use in COPD management are not detailed in the provided context.

What prior FDA approvals exist?

The FDA has approved several pharmacologic treatments for COPD, including long-acting beta agonists (LABAs) like vilanterol, long-acting muscarinic antagonists (LAMAs) such as tiotropium, and combination therapies like umeclidinium/vilanterol. These medications help manage symptoms and improve lung function. While air purifiers with HEPA filters are not a pharmacologic treatment, they aim to reduce airborne particles and allergens, potentially benefiting lung health in COPD patients. This approach is complementary to pharmacologic treatments and focuses on environmental control to alleviate symptoms.

What other types of research exist?

Promising novel alternatives to air purifiers with HEPA filters for COPD patients include bronchoscopic lung volume reduction techniques such as endobronchial valve insertion and bronchoscopic thermal vapor ablation. These methods have shown effectiveness in reducing lung volume and improving respiratory function. Additionally, the use of mucoactive agents like N-acetyl cysteine (NAC) for sputum management and advanced pharmacologic therapies combining long-acting bronchodilators (LAMA/LABA) may offer significant benefits. Environmental interventions, such as reducing exposure to wood smoke and other pollutants, also remain crucial.

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HEPA Filter

Air Purification for Eosinophilic COPD

Q: What is the mechanism of action of this treatment?

The most common treatments for Chronic Obstructive Pulmonary Disease (COPD) include inhaled bronchodilators, such as beta agonists and muscarinic antagonists, which work by relaxing the muscles around the airways to improve airflow and reduce symptoms like dyspnea. Inhaled glucocorticoids are often used to reduce inflammation in the airways. Mucolytic agents help thin mucus, making it easier to clear from the lungs. The use of air purifiers with HEPA filters, as studied in some trials, aims to reduce airborne particles and allergens, potentially decreasing respiratory irritants and improving lung function. This is particularly important for COPD patients, as reducing exposure to environmental triggers can help manage symptoms and prevent exacerbations.

N/A

Waitlist Available

Led By Mary B Rice, MD MPH

Research Sponsored by Beth Israel Deaconess Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Physician diagnosis of COPD [Global Initiative for Obstructive Lung Disease (GOLD) Stage II-IV disease with Forced Expiratory Volume (FEV1)/ Forced Vital Capacity (FVC) ≤70% and FEV1 (% predicted) <80%]

Age of 40 years or more

Must not have

End stage chronic disease with life expectancy <2 years as determined by PI judgment (e.g. under evaluation or listed for lung transplantation, malignancy, severe cirrhosis, severe heart failure)

Inability to perform lung function testing

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline [3 months before intervention and day of intervention] and post intervention [7 days, 6 months and 12 months]

Summary

This trial is testing if using home air purifiers can help adults with a specific type of COPD by cleaning the air they breathe. The goal is to see if this improves their lung health and reduces symptoms.

Who is the study for?

Adults over 40 with eosinophilic COPD, a history of smoking (at least 10 pack-years), and specific lung function test results can join. They must not already use HEPA air purifiers, live in long-term care, plan to move soon, or have severe diseases with less than 2 years life expectancy.

What is being tested?

The trial is testing if home air purifiers improve lung health in people with eosinophilic COPD. Participants are randomly divided into two groups: one gets real HEPA filter air purifiers and the other gets fake ones.

What are the potential side effects?

Since this trial involves using an air purifier versus a sham device, there are no direct medical side effects expected from the interventions themselves.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with moderate to severe COPD.

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I am 40 years old or older.

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I have smoked the equivalent of 10 or more packs of cigarettes per year.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My doctor thinks I have less than 2 years to live due to a severe illness.

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I cannot perform lung function tests.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline [3 months before intervention and day of intervention] and post intervention [7 days, 6 months and 12 months]

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline [3 months before intervention and day of intervention] and post intervention [7 days, 6 months and 12 months]

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline [3 months before intervention and day of intervention] and post intervention [7 days, 6 months and 12 months] for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in forced expiratory volume in 1 second (FEV1)

Secondary study objectives

Change in functional capacity by 6 minute walk test

Change in health status (also called health-related quality of life) by St. George Respiratory Questionnaire

Change in respiratory symptoms

Other study objectives

Change in nasal inflammatory mediators

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: True air purifierExperimental Treatment1 Intervention

Participants will receive a HEPA air purifier in the bedroom and living room.

Group II: Sham air purifierPlacebo Group1 Intervention

Participants will receive a sham air purifier that will be installed in the bedroom and living room. These purifiers will make a noise, but will not filter the air.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Air purifier

2023

N/A

~220

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Chronic Obstructive Pulmonary Disease (COPD) include inhaled bronchodilators, such as beta agonists and muscarinic antagonists, which work by relaxing the muscles around the airways to improve airflow and reduce symptoms like dyspnea. Inhaled glucocorticoids are often used to reduce inflammation in the airways. Mucolytic agents help thin mucus, making it easier to clear from the lungs. The use of air purifiers with HEPA filters, as studied in some trials, aims to reduce airborne particles and allergens, potentially decreasing respiratory irritants and improving lung function. This is particularly important for COPD patients, as reducing exposure to environmental triggers can help manage symptoms and prevent exacerbations.

Chronic obstructive pulmonary disease - diagnosis and management of stable disease; a personalized approach to care, using the treatable traits concept based on clinical phenotypes. Position paper of the Czech Pneumological and Phthisiological Society.Asthma and smoking-induced airway disease without spirometric COPD.A self-management approach using self-initiated action plans for symptoms with ongoing nurse support in patients with Chronic Obstructive Pulmonary Disease (COPD) and comorbidities: the COPE-III study protocol.