Indoor Air Quality and Respiratory Symptoms in Former Smokers
- Conditions
- Chronic Obstructive Pulmonary Disease
- Interventions
- Other: Sham Control/Active ComparatorOther: HEPA portable air filter
- Registration Number
- NCT02956213
- Lead Sponsor
- Intermountain Health Care, Inc.
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 52
- 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
- active tobacco use of subject
- active tobacco use in the home
- pre-existing use of a HEPA filter in the subject's bedroom
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description ARM 2 MERV17 second Sham Control/Active Comparator 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. ARM 1 MERV17 first HEPA portable air filter 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.
- Primary Outcome Measures
Name Time Method Change in SGRQ-C score 12 weeks based on St. George's Respiratory Questionnaire - COPD - SGRQ-C score
- Secondary Outcome Measures
Name Time Method 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
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 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.
Number of cardiovascular events 6 months CVA, MI, heart failure exacerbation
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.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.
Trial Locations
- Locations (1)
Intermountain Medical Center
🇺🇸Salt Lake City, Utah, United States