Chronic Obstructive Pulmonary Disease (COPD)DS-FNCT07118189
Laying the Foundation for Building a Resilient KPNC Community in the Face of Worsening Air Quality Due to Wildfire Smoke
A study testing N95 masks and indoor air cleaner in people with Chronic Obstructive Pulmonary Disease (COPD) and Exacerbation of COPD, run by Kaiser Permanente at 1 site in United States.
Trial summary
The overarching goal of this project is to conduct a pilot intervention in high-risk Kaiser Permanente Northern California patients with chronic obstructive pulmonary disease to mitigate their exposure to poor air quality and decrease exacerbations of lung disease. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD), Exacerbation of COPD, Exacerbation of Chronic Obstructive Pulmonary Disease
- What is being tested?
- N95 masks and indoor air cleaner
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Oct 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- KPNC patients
- enrolled in Care Plus
- non-smoking
- oxygen-dependent
- adults aged ≥65 years old
- have had membership for at least 1 year prior to data extraction not counting </=3mo gaps)
Show all 9Show fewer
- have known COPD (at least 2 encounters with COPD ICD codes over a 3 year period in the 10 years prior to data extraction using the following ICD codes: ICD-9 491.21, 491.22, 491.8, 491.9, 492.8, 493.2, 493.21, 493.22, 496 and ICD-10 J44.1, J44.0, J41.8, J44.9, J42)15
- have picked up at least 1 controller inhaler at the pharmacy within 1 year prior to data extraction
- at least 2 exacerbations of COPD treated in any setting (outpatient or acute care) within 1 year before to data extraction.
Who cannot join
- with <1 year of continuous membership prior to the date they entered the cohort, allowing for 3-month, non-contiguous gaps
- any diagnosis with any of the past or present problems: blindness, dementia, deaf or hearing impaired, hospice admission, "tracheostomy" procedure code or problems and/or attached to a ventilator
- hearing, visually, physically, memory, and/or speech impaired
- those on the "Do Not Call" list
- non-English speakers.
Trial locations and contacts
1 site in 1 country.
United States1 site
Kaiser Permanente Northern California Division of Research
Pleasanton, California, 94588
About this study
The overarching goal of this project is to conduct a pilot intervention in high-risk Kaiser Permanente Northern California patients with chronic obstructive pulmonary disease to mitigate their exposure to poor air quality and decrease exacerbations of lung disease.
Read the detailed description
Over the past decade, the frequency and impact of wildfires has steadily worsened across California, a trend that is expected to continue as climate change becomes an urgent, everyday reality. This means that the number of Kaiser Permanente Northern California (KPNC) members exposed to unhealthy air quality due to wildfire smoke will increase dramatically. Unsurprisingly, vulnerable patients are disproportionately impacted, such as those with chronic obstructive pulmonary disease (COPD). In this rigorous pilot, we will deploy a pilot in-home intervention to non-smoking, oxygen-dependent patients who have frequent exacerbations of COPD to mitigate their exposure to poor air quality and reduce exacerbations.
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD), Exacerbation of COPD, Exacerbation of Chronic Obstructive Pulmonary Disease
- Being tested
- N95 masks and indoor air cleaner
- Keywords
- chronic obstructive pulmonary disease (COPD), air pollution, wildfire smoke
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N95 masks and indoor air cleanerDevice
Participants who are randomized into the intervention will receive N95 masks to be worn outdoors and an indoor air cleaner in the room that the participant spends the most time in their home. Both intervention and control arms will receive education.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants who are randomized into the intervention will receive N95 masks to be worn outdoors and an indoor air cleaner in the room that the participant spends the most time in their home. Both intervention and control arms will receive education. Receives: Device: N95 masks and indoor air cleaner |
| Control | No intervention | Both intervention and control arms will receive education. |
What is being measured
The primary outcome is the main question the study is designed to answer.
feasibility (by percent of enrolled patients who complete all follow-up assessments)
% of enrolled patients who complete all follow-up assessments
Measured: 30 days
fidelity
electrical sensors on the air cleaners showing the device was on for >80% of follow-up time
Measured: 30 days
Secondary outcomes (6)
average screen-to-enrollment ratio
how many patients were contacted to enroll 1 patient
Measured: Through study completion, an average of 18 months
indoor and outdoor PM2.5 concentrations
air quality monitoring devices inside and outside the home, which record data internally when not connected to the internet
Measured: 30 days
respiratory quality of life
via St George's respiratory questionnaire for COPD - Part 1 : Symptoms component (frequency \& severity) with a 1-month recall; Part 2: Activities that cause or are limited by breathlessness; Impact components (social functioning, psychological disturbances resulting from airways disease) refer to current state as the recall (dichotomous (true/false) except last question (4-point Likert scale)); Scores range from 0 to 100, with higher scores indicating more limitations
Measured: 30 days
effectiveness
FEV1 improvement by portable spirometry
Measured: 30 days
acceptability
>90% reporting satisfied/very satisfied on 5-point Likert scale as well as in qualitative interviews for feedback about the intervention, specifically which aspect of the intervention was most/least helpful and most/least burdensome, including aspects that should be changed to increase participation in future trials
Measured: 30 days
Urine oxidative stress
analysis of urinary F2-isoprostanes and Specific Gravity (SG)
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study start7 Oct 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized in-home intervention pilot trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Myers, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07118189
- Sponsor's protocol ID
- 2293325
- Acronym
- DS-F
- Status last verified
- Nov 2025
- First submitted
- 5 Aug 2025
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: organizational guidance
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laying the Foundation for Building a Resilient KPNC Community in the Face of Worsening Air Quality Due to Wildfire Smoke
- ClinicalTrials.gov ID
- NCT07118189
- Acronym / sponsor ID
- DS-F / 2293325
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD), Exacerbation of COPD, Exacerbation of Chronic Obstructive Pulmonary Disease
- Keywords
- chronic obstructive pulmonary disease (COPD), air pollution, wildfire smoke
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Study start
- 7 Oct 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 12 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overarching goal of this project is to conduct a pilot intervention in high-risk Kaiser Permanente Northern California patients with chronic obstructive pulmonary disease to mitigate their exposure to poor air quality and decrease exacerbations of lung disease.
Detailed description
Over the past decade, the frequency and impact of wildfires has steadily worsened across California, a trend that is expected to continue as climate change becomes an urgent, everyday reality. This means that the number of Kaiser Permanente Northern California (KPNC) members exposed to unhealthy air quality due to wildfire smoke will increase dramatically. Unsurprisingly, vulnerable patients are disproportionately impacted, such as those with chronic obstructive pulmonary disease (COPD). In this rigorous pilot, we will deploy a pilot in-home intervention to non-smoking, oxygen-dependent patients who have frequent exacerbations of COPD to mitigate their exposure to poor air quality and reduce exacerbations.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized in-home intervention pilot trial
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: N95 masks and indoor air cleanerParticipants who are randomized into the intervention will receive N95 masks to be worn outdoors and an indoor air cleaner in the room that the participant spends the most time in their home. Both intervention and control arms will receive education. |
| Control | No intervention | –Both intervention and control arms will receive education. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (9 listed)
- KPNC patients
- enrolled in Care Plus
- non-smoking
- oxygen-dependent
- adults aged ≥65 years old
Key exclusion criteria (5 listed)
- with <1 year of continuous membership prior to the date they entered the cohort, allowing for 3-month, non-contiguous gaps
- any diagnosis with any of the past or present problems: blindness, dementia, deaf or hearing impaired, hospice admission, "tracheostomy" procedure code or problems and/or attached to a ventilator
- hearing, visually, physically, memory, and/or speech impaired
- those on the "Do Not Call" list
- non-English speakers.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N95 masks and indoor air cleanerParticipants who are randomized into the intervention will receive N95 masks to be worn outdoors and an indoor air cleaner in the room that the participant spends the most time in their home. Both intervention and control arms will receive education. | Device | Intervention |
Primary outcome
feasibility (by percent of enrolled patients who complete all follow-up assessments)
Time frame: 30 days
% of enrolled patients who complete all follow-up assessments
fidelity
Time frame: 30 days
electrical sensors on the air cleaners showing the device was on for >80% of follow-up time
6 secondary outcomes
average screen-to-enrollment ratio
Time frame: Through study completion, an average of 18 months
indoor and outdoor PM2.5 concentrations
Time frame: 30 days
respiratory quality of life
Time frame: 30 days
effectiveness
Time frame: 30 days
acceptability
Time frame: 30 days
Urine oxidative stress
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Individual participant dataSharing planned: No. organizational guidance
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing N95 masks and indoor air cleaner in people with Chronic Obstructive Pulmonary Disease (COPD) and Exacerbation of COPD, run by Kaiser Permanente at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
feasibility (by percent of enrolled patients who complete all follow-up assessments) (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.