Indoor Air Quality and Respiratory Symptoms in Former Smokers

Intermountain Health Care, Inc.

Status: Completed

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Other: HEPA portable air filter; Other: Sham Control/Active Comparator

Study type: Interventional

Funder types: Other

Identifiers

NCT02956213

1050302

Details and patient eligibility

About

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.

Full 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).

Enrollment: 52 patients

Sex: All

Ages: 40+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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52 participants in 2 patient groups

ARM 1 MERV17 first

Experimental group

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.

Treatment:

Other: HEPA portable air filter

ARM 2 MERV17 second

Active Comparator group

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.

Treatment:

Other: Sham Control/Active Comparator