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

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02236858
• Other study ID #: NA_00085617
• Secondary ID: 1R01ES022607
• Status: Completed
• Phase: N/A
• Start date: March 2014
• Est. completion date: September 10, 2021

Study information

• Verified date: November 2020
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: September 10, 2021
• Est. primary completion date: February 21, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute of Environmental Health Sciences (NIEHS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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