Indoor Air Quality and Respiratory Symptoms in Former Smokers

NCT02956213 | Completed

• 1 other identifier: 1050302
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD; air filter; indoor air quality; respiratory symptoms; emphysema; chronic obstructive pulmonary disease; tobacco use

Outcome Measures

Primary Outcomes (1)

• Change in SGRQ-C score

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

  12 weeks

Secondary Outcomes (7)

• Effect of air filtration on healthcare utilization

  6 months

• Aggregated assessment of the effect of air filtration on COPD exacerbation frequency

  6 months

• Change in median daily step counts

  6 months

• Change in inflammatory markers

  6 months

• Change in spirometry

  3 months

Other Outcomes (9)

• Change in sleep efficiency

  12 weeks

• Change in sleep quality

  12 weeks

• Change in CAT scores

  12 weeks

Study Arms (2)

ARM 1 MERV17 first

EXPERIMENTAL

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

ARM 2 MERV17 second

ACTIVE COMPARATOR

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

Interventions

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.

ARM 1 MERV17 first

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

ARM 2 MERV17 second

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• active tobacco use of subject
• active tobacco use in the home
• pre-existing use of a HEPA filter in the subject's bedroom

Sponsors & Collaborators

• Intermountain Health Care, Inc.: lead

Study Sites (1)

Intermountain Medical Center

Salt Lake City, Utah, 84107, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Signs and Symptoms, Respiratory; Emphysema; Tobacco Use

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Behavior

Study Officials

• Denitza Blagev, MD

  Intermountain Health Care, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2016
• First Posted: November 7, 2016
• Study Start: November 1, 2016
• Primary Completion: May 15, 2019
• Study Completion: June 1, 2019
• Last Updated: June 13, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)