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

Primary Purpose

Chronic Obstructive Pulmonary Disease (COPD)

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

HEPA Air Cleaner

Sham HEPA Air Cleaner

About this trial

This is an interventional other trial for Chronic Obstructive Pulmonary Disease (COPD) focused on measuring COPD

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Johns Hopkins University

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Active Comparator

Arm Label

Sham HEPA Air Cleaner

HEPA Air Cleaner

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in Quality of Life

St. George's Respiratory Questionnaire (SGRQ). The total score is from 0 to 100. Higher scores indicate more limitations

Secondary Outcome Measures

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.

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 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 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 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 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 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.

Full Information

NCT ID

NCT02236858

First Posted

February 24, 2014

Last Updated

September 13, 2021

Sponsor

Johns Hopkins University

Collaborators

National Institute of Environmental Health Sciences (NIEHS)

1. Study Identification

Unique Protocol Identification Number

NCT02236858

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Completed

Study Start Date

March 2014 (Actual)

Primary Completion Date

February 21, 2020 (Actual)

Study Completion Date

September 10, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Johns Hopkins University

Collaborators

National Institute of Environmental Health Sciences (NIEHS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

COPD

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

142 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sham HEPA Air Cleaner

Arm Type

Sham Comparator

Arm Description

Arm Title

HEPA Air Cleaner

Arm Type

Active Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

HEPA Air Cleaner

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Sham HEPA Air Cleaner

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in Quality of Life

Description

St. George's Respiratory Questionnaire (SGRQ). The total score is from 0 to 100. Higher scores indicate more limitations

Time Frame

Change from baseline and at 6 months post randomization

Secondary Outcome Measure Information:

Title

Health care utilization

Description

Time Frame

Baseline through end of study (approximately 6 months post-randomization)

Title

Change in Dyspnea (mMRC)

Description

Dyspnea will be assessed using the modified medical research Council questionnaire (mMRC). The total score is from 0 (no dyspnea) to 2 (severe dyspnea).

Time Frame

Change from baseline and 3 months post-randomization

Title

Change in Dyspnea (mMRC)

Description

Dyspnea will be assessed using the modified medical research Council questionnaire (mMRC). The total score is from 0 (no dyspnea) to 2 (severe dyspnea).

Time Frame

Change from baseline and 6 months post-randomization

Title

Change in COPD health status

Description

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

Time Frame

Change from baseline and 3 months post randomization

Title

Change in COPD health status

Description

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

Time Frame

Change from baseline and 6 months post randomization

Title

Change in Functional status

Description

Functional status will be assessed with the 6 minute walk test. We will assess the distance (in meters) covered a time of 6 minutes.

Time Frame

Change from baseline and 3 months post randomization

Title

Change in Functional status

Description

Functional status will be assessed with the 6 minute walk test. We will assess the distance (in meters) covered a time of 6 minutes.

Time Frame

Change from baseline and 6 months post randomization

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nadia N Hansel, MD, MPH

Organizational Affiliation

Johns Hopkins University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Johns Hopkins University

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21224

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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