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Device

Air Cleaner for COPD (Clean Air Trial)

Phase 3
Recruiting
Research Sponsored by JHSPH Center for Clinical Trials
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥ 40 years
Spirometry confirmed airway obstruction (post-bronchodilator spirometry of forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) < 0.7) as defined by the Global Initiative for Obstructive Lung Disease (GOLD) criteria
Must not have
Inability to bring air cleaners (about 15 pounds each) into home, either by self, friend, or relative
Other chronic lung diseases, except asthma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 3, 6, 9, and 12 months after baseline
Awards & highlights

Summary

This trial aims to investigate if using an air cleaner can help reduce the risk of COPD flare-ups and improve the quality of life for patients.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this trial involves non-medical devices (air cleaners), there aren't typical medication side effects. However, participants may experience disappointment if they receive the sham device and do not see improvements.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 40 years old or older.
Select...
My lung function test shows I have airway obstruction.
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I quit smoking more than 6 months ago, not counting e-cigarettes.
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My doctor has diagnosed me with COPD.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I cannot bring a 15-pound air cleaner into my home by myself or with help.
Select...
I have a chronic lung condition, but it's not asthma.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 3, 6, 9, and 12 months after baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 3, 6, 9, and 12 months after baseline for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
St. George's Respiratory Questionnaire (SGRQ)

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active air cleanerExperimental Treatment1 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 cleanerPlacebo Group1 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.

Find a Location

Who is running the clinical trial?

JHSPH Center for Clinical TrialsLead Sponsor
12 Previous Clinical Trials
9,750 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,889 Previous Clinical Trials
47,833,511 Total Patients Enrolled
~513 spots leftby Sep 2027
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