Air Purification for Eosinophilic COPD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Beth Israel Deaconess Medical Center

Disqualifiers: Inability to complete questionnaires, others

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

Compensation: Varies

Number of Visits: 7

Duration: 12 months

178 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, so it's best to ask the study team for guidance.

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

The air purifier treatment for eosinophilic COPD is unique because it focuses on improving air quality to reduce inflammation, unlike traditional drug treatments that target inflammation directly through medication. This approach is non-invasive and may complement existing therapies by addressing environmental factors contributing to the condition. ^{1 2 3 4 5}

What is the purpose of this trial?

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.

Research Team

Mary B Rice, MD MPH

Principal Investigator

Beth Israel Deaconess Medical Center

Eligibility Criteria

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.

Inclusion Criteria

I have been diagnosed with moderate to severe COPD.

I am 40 years old or older.

Blood eosinophil count of >=150 cells per μL at screening or in the previous year

Exclusion Criteria

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

I cannot perform lung function tests.

Living in location other than home (e.g. long term care facility)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

3 months

Baseline visit

Treatment

Participants receive either a real or sham air purifier in the bedroom and living room for 12 months

12 months

Monthly visits for monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 month

Post-intervention visits at 7 days, 6 months, and 12 months

Treatment Details

Interventions

• Air Purifier
• Sham Air Purifier

Trial Overview 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.

Participant Groups

Group I: True air purifier Experimental Treatment 1 Intervention

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

Group II: Sham air purifier Placebo Group 1 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.

Who Is Running the Clinical Trial?

Beth Israel Deaconess Medical Center

Lead Sponsor

Trials

872

Recruited

12,930,000+

National Institute of Environmental Health Sciences (NIEHS)

Collaborator

Trials

294

Recruited

1,233,000+

References

1. England pubmed.ncbi.nlm.nih.gov

Treatment with interleukin (IL)-5/IL-5 receptor antibodies in patients with severe eosinophilic asthma and COPD. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Eosinophil Inflammation and Hyperresponsiveness in the Airways as Phenotypes of COPD, and Usefulness of Inhaled Glucocorticosteroids. [2020]

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

A GATA3-specific DNAzyme attenuates sputum eosinophilia in eosinophilic COPD patients: a feasibility randomized clinical trial. [2018]

4. Switzerland pubmed.ncbi.nlm.nih.gov

HFA-BDP Metered-Dose Inhaler Exhaled Through the Nose Improves Eosinophilic Chronic Rhinosinusitis With Bronchial Asthma: A Blinded, Placebo-Controlled Study. [2022]

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

Airway inflammation and mannitol challenge test in COPD. [2021]