Clinical Trial of Air Cleaners to Improve Indoor Air Quality and COPD Health
| Status: | Recruiting |
|---|---|
| Conditions: | Chronic Obstructive Pulmonary Disease, Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 40 - Any |
| Updated: | 3/6/2019 |
| Start Date: | March 2014 |
| End Date: | June 2019 |
| Contact: | Cass L. Foster |
| Email: | cfoste16@jhmi.edu |
| Phone: | 410-550-8722 |
Objectives (include all primary and secondary objectives)
Specific Aim #1: To determine whether an air cleaner intervention to improve home air quality
will improve respiratory symptoms, quality of life, lung function and reduce risk of
exacerbations in former smokers with COPD.
Hypothesis: An intervention using high-efficiency particulate air (HEPA) and carbon filter
air cleaners in homes of former smokers with COPD will improve respiratory symptoms, quality
of life, and lung function and reduce risk of COPD exacerbations compared with placebo (sham
air cleaners).
Specific Aim #2: To determine whether an air cleaner intervention to improve home air quality
will be associated with intermediate outcome measures known to be linked with long term
outcomes in COPD, including airway and systemic markers of inflammation and oxidative stress,
in former smokers with COPD.
Hypothesis 2: An intervention using HEPA and carbon filter air cleaners in homes of formers
smokers with COPD will be associated with lower levels of markers of inflammation and
oxidative stress known to be associated with adverse outcomes in patients with COPD.
Specific Aim #1: To determine whether an air cleaner intervention to improve home air quality
will improve respiratory symptoms, quality of life, lung function and reduce risk of
exacerbations in former smokers with COPD.
Hypothesis: An intervention using high-efficiency particulate air (HEPA) and carbon filter
air cleaners in homes of former smokers with COPD will improve respiratory symptoms, quality
of life, and lung function and reduce risk of COPD exacerbations compared with placebo (sham
air cleaners).
Specific Aim #2: To determine whether an air cleaner intervention to improve home air quality
will be associated with intermediate outcome measures known to be linked with long term
outcomes in COPD, including airway and systemic markers of inflammation and oxidative stress,
in former smokers with COPD.
Hypothesis 2: An intervention using HEPA and carbon filter air cleaners in homes of formers
smokers with COPD will be associated with lower levels of markers of inflammation and
oxidative stress known to be associated with adverse outcomes in patients with COPD.
This research is being done to learn whether an air cleaner intervention to improve home air
quality (particulate matter (PM) and nitrogen dioxide (NO2) reduction) will improve
respiratory symptoms, quality of life, lung function, and reduce risk of exacerbations in
former smokers with COPD.
The investigators will place air pollution monitors in the home to measure the air quality
over five 1-week periods (at 3 month and 1 week pre-intervention, and 1 week, 3 months and 6
months post-intervention). During each week of monitoring, the investigators will ask that a
diary be kept of breathing and how the participants are feeling every day.
Participant will have 5 home visits and 5 clinic visits and monthly telephone calls during
this time to see how the participant is feeling. One week after each home visit, the
monitoring equipment will be picked up. After the 2nd monitoring period, active or sham air
cleaners will be placed in home.
quality (particulate matter (PM) and nitrogen dioxide (NO2) reduction) will improve
respiratory symptoms, quality of life, lung function, and reduce risk of exacerbations in
former smokers with COPD.
The investigators will place air pollution monitors in the home to measure the air quality
over five 1-week periods (at 3 month and 1 week pre-intervention, and 1 week, 3 months and 6
months post-intervention). During each week of monitoring, the investigators will ask that a
diary be kept of breathing and how the participants are feeling every day.
Participant will have 5 home visits and 5 clinic visits and monthly telephone calls during
this time to see how the participant is feeling. One week after each home visit, the
monitoring equipment will be picked up. After the 2nd monitoring period, active or sham air
cleaners will be placed in home.
Inclusion Criteria:
- Age ≥ 40 years,
- 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%,
- Tobacco exposure ≥ 10 pack-years, and
- Former smoker. We will employ a combination of self-report and a biochemical marker to
identify former-smokers. Exhaled CO (eCO) will be used as a marker of smoking status,
as it is easy to perform, provides immediate data and is non-invasive. Former-smokers
will be those who report no current smoking in the past 1 year AND have exhaled CO
levels ≤ 6ppm. This threshold was chosen to maximize the chance of distinguishing true
smokers and ex-smokers (>95%).
Exclusion Criteria:
- Chronic systemic corticosteroids (≥ 3 months continuous use in past 12 months),
- Other chronic lung disease including asthma,
- Living in location other than home (e.g., long term care facility) and
- Home owner or home occupant planning to move or change residence within the study
period.
We found this trial at
1
site
3400 N Charles St
Baltimore, Maryland 21205
Baltimore, Maryland 21205
410-516-8000
Phone: 410-550-9527
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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