Indoor Air Quality and Respiratory Symptoms in Former Smokers

Study Overview
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Brief Summary
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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
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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).

Official Title
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Assessing the Effect of Different Efficiency Indoor Air Filters on Respiratory Symptoms in Former Smokers

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Other: HEPA portable air filter
* Other: Sham Control/Active Comparator


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ARM 1 MERV17 first<br>This group will receive a portable HEPA air filtering device with MERV17 air filter for the first part of the study. At cross over, this group will receive the placebo or no high-efficiency filter. | Other: HEPA portable air filter<br>* 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.<br>|
| Active Comparator: ARM 2 MERV17 second<br>This group will receive a HEPA portable air filter with no high efficiency air filter for the first part of the study. At cross over, this group will receive the high-efficiency MERV17 air filter. | Other: Sham Control/Active Comparator<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in SGRQ-C score | based on St. George's Respiratory Questionnaire - COPD - SGRQ-C score | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of air filtration on healthcare utilization | Effect on COPD related ER visits and hospitalizations; CHF and MI related visits and hospitalizations and all cause ER visits and hospitalizations | 6 months | 
| Aggregated assessment of the effect of air filtration on COPD exacerbation frequency | 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. | 6 months | 
| Change in median daily step counts | 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. | 6 months | 
| Change in inflammatory markers | 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. | 6 months | 
| Change in spirometry | 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. | 3 months | 
| Number of cardiovascular events | CVA, MI, heart failure exacerbation | 6 months | 
| Change in 6 minute walk test | 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. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, air filter, indoor air quality, respiratory symptoms, emphysema, chronic obstructive pulmonary disease, tobacco use