Clinical trial NCT02956213: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
air filter
indoor air quality
respiratory symptoms
emphysema
chronic obstructive pulmonary disease
tobacco use
Lead sponsor: Intermountain Health Care, Inc.
Sponsor class: OTHER
First posted: 2016-11-06
Enrollment: 52
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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).

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

Primary outcomes:
measure: Change in SGRQ-C score
timeFrame: 12 weeks
Secondary outcomes:
measure: Effect of air filtration on healthcare utilization
timeFrame: 6 months
measure: Aggregated assessment of the effect of air filtration on COPD exacerbation frequency
timeFrame: 6 months
measure: Change in median daily step counts
timeFrame: 6 months
measure: Change in inflammatory markers
timeFrame: 6 months
measure: Change in spirometry
timeFrame: 3 months
measure: Number of cardiovascular events
timeFrame: 6 months
measure: Change in 6 minute walk test
timeFrame: 3 months
Other outcomes:
measure: Change in sleep efficiency
timeFrame: 12 weeks
measure: Change in sleep quality
timeFrame: 12 weeks
measure: Change in CAT scores
timeFrame: 12 weeks
measure: Change in mMRC scores
timeFrame: 12 weeks
measure: Change in other metrics of activity: specifically 6min walk distances and max walk distance
timeFrame: 12 weeks
measure: Change in air filter changing habits
timeFrame: 12 months
measure: Change in air filter weight with different filters (surrogate for particulates trapped)
timeFrame: 12 months
measure: Change in activity tracker use following study
timeFrame: 12 months
measure: Change in indoor particulate concentration as measured by personal air monitors (PurpleAir.org)
timeFrame: 3 months
Locations:
city: Salt Lake City
country: United States
facility: Intermountain Medical Center
state: Utah
Study officials:
affiliation: Intermountain Health Care, Inc.
name: Denitza Blagev, MD
role: PRINCIPAL_INVESTIGATOR
References: