Chronic Obstructive Pulmonary DiseaseNCT02956213
Indoor Air Quality and Respiratory Symptoms in Former Smokers
A study testing HEPA portable air filter in people with Chronic Obstructive Pulmonary Disease, run by Intermountain Health Care, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- HEPA portable air filter
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- active tobacco use of subject
- active tobacco use in the home
- pre-existing use of a HEPA filter in the subject's bedroom
Trial locations and contacts
1 site in 1 country.
United States1 site
Intermountain Medical Center
Salt Lake City, Utah, 84107
About this study
Official title: Assessing the Effect of Different Efficiency Indoor Air Filters on Respiratory Symptoms in Former Smokers
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.
Read the 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).
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- HEPA portable air filter, Sham Control/Active Comparator
- Keywords
- COPD, air filter, indoor air quality, respiratory symptoms, emphysema, chronic obstructive pulmonary disease, tobacco use
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Signs and Symptoms, Respiratory, Emphysema, Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HEPA portable air filterOther
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 ComparatorOther
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
| Study group | Role | What they receive |
|---|---|---|
| ARM 1 MERV17 first | Experimental | 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. Receives: Other: HEPA portable air filter |
| ARM 2 MERV17 second | 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. Receives: Other: Sham Control/Active Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in SGRQ-C score
based on St. George's Respiratory Questionnaire - COPD - SGRQ-C score
Measured: 12 weeks
Secondary outcomes (7)
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 months
Number of cardiovascular events
CVA, MI, heart failure exacerbation
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2016 (estimated)
- Study startNov 2016
- Primary completion15 May 2019
- Study completionJun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intermountain Health Care, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Denitza Blagev, MD, Principal investigator, Intermountain Health Care, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02956213
- Sponsor's protocol ID
- 1050302
- Status last verified
- Jun 2019
- First submitted
- 19 Oct 2016
- Last updated
- 13 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Effect of Different Efficiency Indoor Air Filters on Respiratory Symptoms in Former Smokers
- ClinicalTrials.gov ID
- NCT02956213
- Acronym / sponsor ID
- 1050302
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, air filter, indoor air quality, respiratory symptoms, emphysema, chronic obstructive pulmonary disease, tobacco use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Intermountain Health Care, Inc.University, hospital or other
- Study start
- Nov 2016
- Primary completion
- 15 May 2019 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 7 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARM 1 MERV17 first | Experimental | Other: HEPA portable air filterThis 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. |
| ARM 2 MERV17 second | Active comparator | Other: Sham Control/Active ComparatorThis 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- active tobacco use of subject
- active tobacco use in the home
- pre-existing use of a HEPA filter in the subject's bedroom
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HEPA portable air filterA 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. | Other | ARM 1 MERV17 first |
| Sham Control/Active ComparatorA 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 | Other | ARM 2 MERV17 second |
Primary outcome
Change in SGRQ-C score
Time frame: 12 weeks
based on St. George's Respiratory Questionnaire - COPD - SGRQ-C score
7 secondary outcomes
Effect of air filtration on healthcare utilization
Time frame: 6 months
Aggregated assessment of the effect of air filtration on COPD exacerbation frequency
Time frame: 6 months
Change in median daily step counts
Time frame: 6 months
Change in inflammatory markers
Time frame: 6 months
Change in spirometry
Time frame: 3 months
Number of cardiovascular events
Time frame: 6 months
Change in 6 minute walk test
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Denitza Blagev, MD principal investigator
Intermountain Health Care, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HEPA portable air filter in people with Chronic Obstructive Pulmonary Disease, run by Intermountain Health Care, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in SGRQ-C score (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2019; AzTrials last refreshed its copy on 8 Nov 2026.