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Completed

NCT Number: NCT02956213

Indoor Air Quality and 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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Behavior Chronic Disease Disease Attributes Emphysema Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Tobacco Use

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Intermountain Medical Center

Salt Lake City, Utah, 84107, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HEPA portable air filter

Other

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

Other

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 outcomes

  1. Change in SGRQ-C score

    Time frame: 12 weeks

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

Secondary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Intermountain Health Care, Inc.

Other

Registry information

Official study title

Assessing the Effect of Different Efficiency Indoor Air Filters on Respiratory Symptoms in Former Smokers

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Nov 7, 2016
Registry last updated
Jun 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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