N95 Masks and Air Cleaners for COPD

(DS-F Trial)

CA
LC
Overseen ByLaura C Myers, MD, MPH
Age: 65+
Sex: Any
Trial Phase: Academic
Sponsor: Kaiser Permanente
Must be taking: Controller inhalers
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether N95 masks and air cleaners can help individuals with chronic obstructive pulmonary disease (COPD) breathe easier by reducing exposure to poor air quality. Participants will either receive N95 masks and an air cleaner or receive education about managing COPD. The trial aims to determine if these tools can decrease lung problem flare-ups. It is suitable for non-smoking, oxygen-dependent patients with COPD who have experienced at least two doctor-treated flare-ups in the past year. Participants must be part of the Kaiser Permanente Northern California Care Plus program. As an unphased trial, this study offers a unique opportunity for patients to contribute to innovative research that could enhance COPD management.

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 is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that N95 masks and indoor air cleaners are safe for COPD patients?

Research has shown that wearing N95 masks for individuals with mild COPD (a lung condition) usually doesn't cause major problems. However, some studies suggest these masks might make breathing harder and increase tiredness during physical activity. They can also affect blood oxygen and carbon dioxide levels.

Regarding indoor air cleaners, studies have found they can reduce harmful particles in the air by about 50-60%. This reduction can help with breathing and lessen symptoms for people with COPD. Overall, both masks and air cleaners have been researched. While masks might cause some discomfort, air cleaners seem to help with breathing issues.12345

Why are researchers excited about this trial?

Researchers are excited about using N95 masks and air cleaners for COPD because these tools offer a non-pharmaceutical approach to managing the condition. Unlike traditional treatments, which often include inhalers, bronchodilators, and steroids to manage symptoms, this method focuses on reducing exposure to harmful airborne particles. By preventing inhalation of pollutants and allergens, this approach could lead to better lung health and improved quality of life for those with COPD without the side effects associated with medications.

What evidence suggests that N95 masks and indoor air cleaners are effective for COPD?

This trial will evaluate the use of N95 masks and indoor air cleaners for individuals with COPD. Research has shown that N95 masks can make breathing harder for people with COPD, with some studies finding that wearing these masks can increase breathing difficulty and raise heart rate. However, these masks block harmful particles, potentially reducing exposure to poor air quality. Meanwhile, indoor air cleaners have shown promise in improving lung health in COPD patients. Studies have found that these devices can effectively lower indoor air pollution, which may lead to easier breathing and fewer symptoms. Overall, air cleaners could help create a healthier home for those with COPD. Participants in the intervention arm of this trial will receive both N95 masks and an indoor air cleaner.34678

Are You a Good Fit for This Trial?

This trial is for Kaiser Permanente Northern California members aged 65 or older with chronic obstructive pulmonary disease (COPD). They must have had at least two COPD exacerbations in the past year, be enrolled in Care Plus, and have used a controller inhaler. Participants cannot be on the 'Do Not Call' list, non-English speakers, or have significant impairments like blindness or dementia.

Inclusion Criteria

Have had membership for at least 1 year prior to data extraction not counting ≤3mo gaps
I have had at least 2 flare-ups of my COPD in the last year.
KPNC patients enrolled in Care Plus
See 3 more

Exclusion Criteria

Presence on the 'Do Not Call' list
Non-English speakers
I have difficulties with hearing, seeing, moving, remembering, or speaking.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive N95 masks and an indoor air cleaner; both intervention and control arms receive education

30 days
1 visit (in-person) for device setup and education

Follow-up

Participants are monitored for feasibility, fidelity, and effectiveness of the intervention

30 days
Follow-up assessments conducted virtually

Long-term Monitoring

Monitoring of indoor and outdoor air quality and respiratory quality of life

18 months

What Are the Treatments Tested in This Trial?

Interventions

  • Indoor air cleaner
  • N95 masks
Trial Overview The study tests whether N95 masks and indoor air cleaners can help high-risk COPD patients by reducing their exposure to poor air quality from wildfire smoke and decreasing lung disease flare-ups.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 Intervention
Group II: ControlActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Kaiser Permanente

Lead Sponsor

Trials
563
Recruited
27,400,000+

Citations

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 ...
Randomized Clinical Trial of Air Cleaners to Improve ...This is the first environmental intervention study conducted among former smokers with COPD showing potential health benefits of portable high-efficiency ...
Cleaning indoor air—what works for respiratory healthSeveral studies, including those focused on asthma and chronic obstructive pulmonary disease, demonstrated improvement in symptoms and medication receipt with ...
Real-World Effectiveness of Portable Air Cleaners in ...As one of the first studies to evaluate the effectiveness of a PAC on a secondary room, we found that our overall PAC effectiveness values of 57.9% for PM2.5 ...
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 ...
6.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/34449285/
Randomized Clinical Trial of Air Cleaners to Improve ...Rationale: Indoor particulate matter is associated with worse chronic obstructive pulmonary disease (COPD) outcomes.
Respiratory Impact of Indoor Air Quality in Chronic ...Randomized clinical trial of air cleaners to improve indoor air quality and chronic obstructive pulmonary disease health: results of the CLEAN AIR study. Am ...
COPD and Particulate MatterA recent study showed that individuals with COPD who consistently used HEPA air cleaners for six months experienced fewer symptoms, had improved ...
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