Clinical Trial of Air Cleaners to Improve Indoor Air Quality and COPD Health

Objectives (include all primary and secondary objectives)

Specific Aim #1: To determine whether an air cleaner intervention to improve home air quality will improve respiratory symptoms, quality of life, lung function and reduce risk of exacerbations in former smokers with COPD.

Hypothesis: An intervention using high-efficiency particulate air (HEPA) and carbon filter air cleaners in homes of former smokers with COPD will improve respiratory symptoms, quality of life, and lung function and reduce risk of COPD exacerbations compared with placebo (sham air cleaners).

Specific Aim #2: To determine whether an air cleaner intervention to improve home air quality will be associated with intermediate outcome measures known to be linked with long term outcomes in COPD, including airway and systemic markers of inflammation and oxidative stress, in former smokers with COPD.

Hypothesis 2: An intervention using HEPA and carbon filter air cleaners in homes of formers smokers with COPD will be associated with lower levels of markers of inflammation and oxidative stress known to be associated with adverse outcomes in patients with COPD.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Intervention / Treatment: Device: Sham HEPA Air Cleaner; Device: HEPA Air Cleaner

Detailed Description

This research is being done to learn whether an air cleaner intervention to improve home air quality (particulate matter (PM) and nitrogen dioxide (NO2) reduction) will improve respiratory symptoms, quality of life, lung function, and reduce risk of exacerbations in former smokers with COPD.

The investigators will place air pollution monitors in the home to measure the air quality over five 1-week periods (at 3 month and 1 week pre-intervention, and 1 week, 3 months and 6 months post-intervention). During each week of monitoring, the investigators will ask that a diary be kept of breathing and how the participants are feeling every day.

Participant will have 5 home visits and 5 clinic visits and monthly telephone calls during this time to see how the participant is feeling. One week after each home visit, the monitoring equipment will be picked up. After the 2nd monitoring period, active or sham air cleaners will be placed in home.

• Study Type: Interventional
• Enrollment (Actual): 142
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Johns Hopkins University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 36 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age ≥ 40 years,
• Physician diagnosis of COPD,
• Global Initiative for Obstructive Lung Disease (GOLD) Stage II-IV disease with Forced Expiratory Volume (FEV1)/ Forced Vital Capacity (FVC) ≤70% and FEV1 (% predicted) <80%,
• Tobacco exposure ≥ 10 pack-years, and
• Former smoker. We will employ a combination of self-report and a biochemical marker to identify former-smokers. Exhaled CO (eCO) will be used as a marker of smoking status, as it is easy to perform, provides immediate data and is non-invasive. Former-smokers will be those who report no current smoking in the past 1 year AND have exhaled CO levels ≤ 6ppm. This threshold was chosen to maximize the chance of distinguishing true smokers and ex-smokers (>95%).

Exclusion Criteria:

• Chronic systemic corticosteroids (≥ 3 months continuous use in past 12 months),
• Other chronic lung disease including asthma,
• Living in location other than home (e.g., long term care facility) and
• Home owner or home occupant planning to move or change residence within the study period.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Sham HEPA Air Cleaner; Sham HEPA Air Cleaner and Delayed Intervention. Homes in the control group will receive sham air cleaners that have the internal HEPA and carbon filters removed, but which will run normally, including similar noise, airflow and overall appearance compared to active air cleaners, thus blinding participants to filter status.	Device: Sham HEPA Air Cleaner; Homes in the control group will receive sham air cleaners that have the internal HEPA and carbon filters removed, but which will run normally, including similar noise, airflow and overall appearance compared to active air cleaners, thus blinding participants to filter status.
Active Comparator: HEPA Air Cleaner; HEPA Air Cleaner also containing carbon filters (Austin HealthMate HM400) and capable of removing PM and NO2 will be placed in the bedroom and room where the participant reports spending the most time. These air cleaners are suitably sized to provide clean air delivery rates for the rooms in which they will be placed. Participants will be instructed to run the air cleaners continually during the course of the study and the units will be modified to prevent them from being turned off by the participants.	Device: HEPA Air Cleaner; Air cleaners containing HEPA and carbon filters (Austin HealthMate HM400) and capable of removing PM and NO2 will be placed in the bedroom and room where the participant reports spending the most time.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Quality of Life	St. George's Respiratory Questionnaire (SGRQ). The total score is from 0 to 100. Higher scores indicate more limitations	Change from baseline and at 6 months post randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health care utilization	Aggregate Exacerbations including (need for oral corticosteroids or antibiotics for worsening respiratory symptoms, emergency department (ED) visit or hospitalization). During this 6 months exacerbations will be collected at monthly telephone calls and at 3 and 6 month clinic visits. Whether an exacerbation occurred over this 6 month period will be assessed.	Baseline through end of study (approximately 6 months post-randomization)
Change in Dyspnea (mMRC)	Dyspnea will be assessed using the modified medical research Council questionnaire (mMRC). The total score is from 0 (no dyspnea) to 2 (severe dyspnea).	Change from baseline and 3 months post-randomization
Change in Dyspnea (mMRC)	Dyspnea will be assessed using the modified medical research Council questionnaire (mMRC). The total score is from 0 (no dyspnea) to 2 (severe dyspnea).	Change from baseline and 6 months post-randomization
Change in COPD health status	Functional status will be assessed with the COPD assessment test (CAT). The total score is from 0 to 40. Higher scores indicate worse COPD control	Change from baseline and 3 months post randomization
Change in COPD health status	Functional status will be assessed with the COPD assessment test (CAT). The total score is from 0 to 40. Higher scores indicate worse COPD control	Change from baseline and 6 months post randomization
Change in Functional status	Functional status will be assessed with the 6 minute walk test. We will assess the distance (in meters) covered a time of 6 minutes.	Change from baseline and 3 months post randomization
Change in Functional status	Functional status will be assessed with the 6 minute walk test. We will assess the distance (in meters) covered a time of 6 minutes.	Change from baseline and 6 months post randomization

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: National Institute of Environmental Health Sciences (NIEHS)
• Investigators: Principal Investigator: Nadia N Hansel, MD, MPH, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2014
• Primary Completion (Actual): February 21, 2020
• Study Completion (Actual): September 10, 2021

Study Registration Dates

• First Submitted: February 24, 2014
• First Submitted That Met QC Criteria: September 10, 2014
• First Posted (Estimate): September 11, 2014

Study Record Updates

• Last Update Posted (Actual): September 14, 2021
• Last Update Submitted That Met QC Criteria: September 13, 2021
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: COPD
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: NA_00085617; 1R01ES022607 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No