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Indoor Air Quality and Respiratory Symptoms in Former Smokers

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ClinicalTrials.gov Identifier: NCT02956213
Recruitment Status : Completed
First Posted : November 7, 2016
Last Update Posted : June 13, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Other: HEPA portable air filter Other: Sham Control/Active Comparator Not Applicable

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).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Assessing the Effect of Different Efficiency Indoor Air Filters on Respiratory Symptoms in Former Smokers
Study Start Date : November 2016
Actual Primary Completion Date : May 15, 2019
Actual Study Completion Date : June 2019

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.
Other: 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.

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.
Other: 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




Primary Outcome Measures :
  1. Change in SGRQ-C score [ Time Frame: 12 weeks ]
    based on St. George's Respiratory Questionnaire - COPD - SGRQ-C score


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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.

  4. 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.


  5. 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.

  6. Number of cardiovascular events [ Time Frame: 6 months ]
    CVA, MI, heart failure exacerbation

  7. 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.


Other Outcome Measures:
  1. Change in sleep efficiency [ Time Frame: 12 weeks ]
    As measured by the activity tracker, the amount of hours slept

  2. Change in sleep quality [ Time Frame: 12 weeks ]
    As measured by the activity tracker, the number of disruptions in sleep

  3. Change in CAT scores [ Time Frame: 12 weeks ]
    COPD assessment test is a questionnaire used to determine subjective improve or progression of COPD.

  4. Change in mMRC scores [ Time Frame: 12 weeks ]
    Modified Medical Research Council Dyspnea Scale score used to track a subject's shortness of breath

  5. Change in other metrics of activity: specifically 6min walk distances and max walk distance [ Time Frame: 12 weeks ]
    walk distance

  6. Change in air filter changing habits [ Time Frame: 12 months ]
    Change in air filter changing habits

  7. 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)

  8. 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.

  9. 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



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02956213


Locations
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United States, Utah
Intermountain Medical Center
Salt Lake City, Utah, United States, 84107
Sponsors and Collaborators
Intermountain Health Care, Inc.
Investigators
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Principal Investigator: Denitza Blagev, MD Intermountain Health Care, Inc.

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Responsible Party: Intermountain Health Care, Inc.
ClinicalTrials.gov Identifier: NCT02956213     History of Changes
Other Study ID Numbers: 1050302
First Posted: November 7, 2016    Key Record Dates
Last Update Posted: June 13, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Intermountain Health Care, Inc.:
COPD
air filter
indoor air quality
respiratory symptoms
emphysema
chronic obstructive pulmonary disease
tobacco use
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Signs and Symptoms, Respiratory
Respiratory Tract Diseases
Signs and Symptoms