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Indoor Air Quality and Respiratory Symptoms in Former Smokers

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HEPA portable air filter
Sham Control/Active Comparator
Sponsored by
Intermountain Health Care, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, air filter, indoor air quality, respiratory symptoms, emphysema, chronic obstructive pulmonary disease, tobacco use

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Intermountain Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ARM 1 MERV17 first

ARM 2 MERV17 second

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in SGRQ-C score
based on St. George's Respiratory Questionnaire - COPD - SGRQ-C score

Secondary Outcome Measures

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
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.
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.
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.
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.
Number of cardiovascular events
CVA, MI, heart failure exacerbation
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.

Full Information

First Posted
October 19, 2016
Last Updated
June 12, 2019
Sponsor
Intermountain Health Care, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02956213
Brief Title
Indoor Air Quality and Respiratory Symptoms in Former Smokers
Official Title
Assessing the Effect of Different Efficiency Indoor Air Filters on Respiratory Symptoms in Former Smokers
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
November 2016 (undefined)
Primary Completion Date
May 15, 2019 (Actual)
Study Completion Date
June 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Intermountain Health Care, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
COPD, air filter, indoor air quality, respiratory symptoms, emphysema, chronic obstructive pulmonary disease, tobacco use

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ARM 1 MERV17 first
Arm Type
Experimental
Arm Description
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.
Arm Title
ARM 2 MERV17 second
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
HEPA portable air filter
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Sham Control/Active Comparator
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in SGRQ-C score
Description
based on St. George's Respiratory Questionnaire - COPD - SGRQ-C score
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Effect of air filtration on healthcare utilization
Description
Effect on COPD related ER visits and hospitalizations; CHF and MI related visits and hospitalizations and all cause ER visits and hospitalizations
Time Frame
6 months
Title
Aggregated assessment of the effect of air filtration on COPD exacerbation frequency
Description
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.
Time Frame
6 months
Title
Change in median daily step counts
Description
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.
Time Frame
6 months
Title
Change in inflammatory markers
Description
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.
Time Frame
6 months
Title
Change in spirometry
Description
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.
Time Frame
3 months
Title
Number of cardiovascular events
Description
CVA, MI, heart failure exacerbation
Time Frame
6 months
Title
Change in 6 minute walk test
Description
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.
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
Change in sleep efficiency
Description
As measured by the activity tracker, the amount of hours slept
Time Frame
12 weeks
Title
Change in sleep quality
Description
As measured by the activity tracker, the number of disruptions in sleep
Time Frame
12 weeks
Title
Change in CAT scores
Description
COPD assessment test is a questionnaire used to determine subjective improve or progression of COPD.
Time Frame
12 weeks
Title
Change in mMRC scores
Description
Modified Medical Research Council Dyspnea Scale score used to track a subject's shortness of breath
Time Frame
12 weeks
Title
Change in other metrics of activity: specifically 6min walk distances and max walk distance
Description
walk distance
Time Frame
12 weeks
Title
Change in air filter changing habits
Description
Change in air filter changing habits
Time Frame
12 months
Title
Change in air filter weight with different filters (surrogate for particulates trapped)
Description
Change in air filter weight with different filters (surrogate for particulates trapped)
Time Frame
12 months
Title
Change in activity tracker use following study
Description
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.
Time Frame
12 months
Title
Change in indoor particulate concentration as measured by personal air monitors (PurpleAir.org)
Description
Change in indoor particulate concentration as measured by personal air
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Denitza Blagev, MD
Organizational Affiliation
Intermountain Health Care, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Intermountain Medical Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Indoor Air Quality and Respiratory Symptoms in Former Smokers

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