Chronic Obstructive Pulmonary Disease
Conditions
Keywords
COPD, air filter, indoor air quality, respiratory symptoms, emphysema, chronic obstructive pulmonary disease, tobacco use
Brief summary
The investigators will conduct a randomized, controlled, double-blind, crossover trial to determine whether the presence of a portable high-efficiency indoor air filter in the bedroom reduces respiratory symptoms in former smokers compared with placebo. The primary outcomes will be change in St. George's Respiratory Questionnaire - COPD (SGRQ-C) score associated with using a portable high-efficiency indoor air filter during the study period. Secondary outcomes of COPD exacerbations and hospitalizations, daily step counts, medication changes, spirometry, and cardiovascular outcomes will also be assessed.
Detailed description
Hypothesis/Research Questions: This study will determine whether the presence of a portable high-efficiency indoor air filter in the bedroom improves respiratory symptoms (based on St. George's Respiratory Questionnaire - COPD - SGRQ-C score) during a period of high air pollution compared with placebo in former smokers with respiratory symptoms. The primary outcome will be the change in SGRQ-C score associated with using a portable high-efficiency indoor air filter during the study period. Secondary outcomes will assess the effect of using a portable high-efficiency indoor air filter on healthcare utilization, other symptom scores, COPD exacerbation frequency, medication use, median daily step counts, inflammatory markers, oxygenation, indoor particulate counts and indoor-outdoor particulate count difference, and pulmonary function tests. Baseline descriptive statistics will report baseline air filter type, duration of use, and particulate weight prior to study enrollment. Evaluation of change in symptom scores and other secondary outcomes from baseline to study air filter (Visit 1 vs. Visit 2).
Interventions
OTHERHEPA portable air filter
A high efficiency (MERV17) portable air filter (HEPA portable air filter) will be placed in the subject's bedroom and will run 24/7 for the duration of the study.
OTHERSham Control/Active Comparator
A portable air filtering device will be placed with no high-efficiency air filter, but only the basic carbon filter in place. Then at cross over, there will be an active HEPA portable air filter used
Sponsors
Intermountain Health Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* history of smoking * Do not currently smoke and no one currently smokes inside the home * history of exacerbation or development of respiratory symptoms (e.g.cough, sputum production, chest tightness, exertional dyspnea, etc.) with periods of high outdoor air pollution (inversions) * Age 40 or older * Access to Wi-Fi * Access to a cell phone, tablet or personal computer
Exclusion criteria
* active tobacco use of subject * active tobacco use in the home * pre-existing use of a HEPA filter in the subject's bedroom
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in SGRQ-C score | 12 weeks | based on St. George's Respiratory Questionnaire - COPD - SGRQ-C score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Aggregated assessment of the effect of air filtration on COPD exacerbation frequency | 6 months | A combined assessment of patient reported symptom questionnaires including increased medication use, ER visits and hospitalizations for breathing-related problems and COPD exacerbations. These assessments will be determined by patient reported hospitalizations/ED visits, and patient reported symptom increase and COPD-related medication changes. |
| Change in median daily step counts | 6 months | Whether median daily step counts are affected by air pollution levels, or correlate with other metrics of COPD outcomes remains unknown and thus, step counts will be tracked. |
| Change in inflammatory markers | 6 months | This is a common office test used to assess how well the lungs work by measuring how much air the patients inhale, how much they exhale, and how quickly they exhale. We will also perform pulse oximetry and a blood draw to assess inflammatory markers and basic labs. COPD sufferers experience inflammation due to their disease. Inflammatory markers will be documented during their clinic visits. |
| Effect of air filtration on healthcare utilization | 6 months | Effect on COPD related ER visits and hospitalizations; CHF and MI related visits and hospitalizations and all cause ER visits and hospitalizations |
| Number of cardiovascular events | 6 months | CVA, MI, heart failure exacerbation |
| Change in 6 minute walk test | 3 months | The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity. |
| Change in spirometry | 3 months | Spirometry will be used to assess how well a subject's lungs work by measuring how much air is inhaled, how much is exhaled and how quickly you exhale. Spirometry is used to diagnose COPD and tracks it's progression or improve. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in sleep efficiency | 12 weeks | As measured by the activity tracker, the amount of hours slept |
| Change in indoor particulate concentration as measured by personal air monitors (PurpleAir.org) | 3 months | Change in indoor particulate concentration as measured by personal air |
| Change in sleep quality | 12 weeks | As measured by the activity tracker, the number of disruptions in sleep |
| Change in CAT scores | 12 weeks | COPD assessment test is a questionnaire used to determine subjective improve or progression of COPD. |
| Change in mMRC scores | 12 weeks | Modified Medical Research Council Dyspnea Scale score used to track a subject's shortness of breath |
| Change in other metrics of activity: specifically 6min walk distances and max walk distance | 12 weeks | walk distance |
| Change in air filter changing habits | 12 months | Change in air filter changing habits |
| Change in air filter weight with different filters (surrogate for particulates trapped) | 12 months | Change in air filter weight with different filters (surrogate for particulates trapped) |
| Change in activity tracker use following study | 12 months | Question in 6 month follow up from study if participants bought their own step counter or if they already had a step counter, if they use the device more as a result of the study. |
Countries
United States
Outcome results
None listed