Indoor Air Quality and Respiratory Symptoms in Former Smokers
NCT ID: NCT02956213
Last Updated: 2019-06-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
52 participants
INTERVENTIONAL
2016-11-30
2019-06-30
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
TRIPLE
Study Groups
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ARM 1 MERV17 first
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.
HEPA 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.
ARM 2 MERV17 second
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.
Sham 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
Interventions
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HEPA 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.
Sham 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
Eligibility Criteria
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Inclusion Criteria
* 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 in the home
* pre-existing use of a HEPA filter in the subject's bedroom
40 Years
ALL
No
Sponsors
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Intermountain Health Care, Inc.
OTHER
Responsible Party
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Principal Investigators
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Denitza Blagev, MD
Role: PRINCIPAL_INVESTIGATOR
Intermountain Health Care, Inc.
Locations
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Intermountain Medical Center
Salt Lake City, Utah, United States
Countries
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Other Identifiers
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1050302
Identifier Type: -
Identifier Source: org_study_id
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