- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02956213
Indoor Air Quality and Respiratory Symptoms in Former Smokers
Assessing the Effect of Different Efficiency Indoor Air Filters on Respiratory Symptoms in Former Smokers
Study Overview
Status
Conditions
Intervention / Treatment
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).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Utah
-
Salt Lake City, Utah, United States, 84107
- Intermountain Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
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.
|
Active Comparator: 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.
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in SGRQ-C score
Time Frame: 12 weeks
|
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
Time Frame: 6 months
|
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
Time Frame: 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.
|
6 months
|
Change in median daily step counts
Time Frame: 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.
|
6 months
|
Change in inflammatory markers
Time Frame: 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. |
6 months
|
Change in spirometry
Time Frame: 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.
|
3 months
|
Number of cardiovascular events
Time Frame: 6 months
|
CVA, MI, heart failure exacerbation
|
6 months
|
Change in 6 minute walk test
Time Frame: 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.
|
3 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in sleep efficiency
Time Frame: 12 weeks
|
As measured by the activity tracker, the amount of hours slept
|
12 weeks
|
Change in sleep quality
Time Frame: 12 weeks
|
As measured by the activity tracker, the number of disruptions in sleep
|
12 weeks
|
Change in CAT scores
Time Frame: 12 weeks
|
COPD assessment test is a questionnaire used to determine subjective improve or progression of COPD.
|
12 weeks
|
Change in mMRC scores
Time Frame: 12 weeks
|
Modified Medical Research Council Dyspnea Scale score used to track a subject's shortness of breath
|
12 weeks
|
Change in other metrics of activity: specifically 6min walk distances and max walk distance
Time Frame: 12 weeks
|
walk distance
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12 weeks
|
Change in air filter changing habits
Time Frame: 12 months
|
Change in air filter changing habits
|
12 months
|
Change in air filter weight with different filters (surrogate for particulates trapped)
Time Frame: 12 months
|
Change in air filter weight with different filters (surrogate for particulates trapped)
|
12 months
|
Change in activity tracker use following study
Time Frame: 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.
|
12 months
|
Change in indoor particulate concentration as measured by personal air monitors (PurpleAir.org)
Time Frame: 3 months
|
Change in indoor particulate concentration as measured by personal air
|
3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Denitza Blagev, MD, Intermountain Health Care, Inc.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1050302
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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