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

NCT02236858 | Completed DMC

• 2 other identifiers: NA_000856171R01ES022607
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

COPD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Health care utilization

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

• Change in Dyspnea (mMRC)

  Change from baseline and 3 months post-randomization

• Change in Dyspnea (mMRC)

  Change from baseline and 6 months post-randomization

• Change in COPD health status

  Change from baseline and 3 months post randomization

• Change in COPD health status

  Change from baseline and 6 months post randomization

Study Arms (2)

Sham HEPA Air Cleaner

SHAM COMPARATOR

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

HEPA Air Cleaner

ACTIVE COMPARATOR

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

Interventions

HEPA Air Cleaner DEVICE

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.

HEPA Air Cleaner

Sham HEPA Air Cleaner DEVICE

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.

Sham HEPA Air Cleaner

Eligibility Criteria

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

You may qualify if:

• 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%).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute of Environmental Health Sciences (NIEHS): collaborator

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21224, United States

Location

Related Publications (1)

• Woo H, Koehler K, Putcha N, Lorizio W, McCormack M, Peng R, Hansel NN. Principal stratification analysis to determine health benefit of indoor air pollution reduction in a randomized environmental intervention in COPD: Results from the CLEAN AIR study. Sci Total Environ. 2023 Apr 10;868:161573. doi: 10.1016/j.scitotenv.2023.161573. Epub 2023 Jan 18.

  PMID: 36669663 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

• Nadia N Hansel, MD, MPH

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2014
• First Posted: September 11, 2014
• Study Start: March 1, 2014
• Primary Completion: February 21, 2020
• Study Completion: September 10, 2021
• Last Updated: September 14, 2021

Record last verified: 2020-11

Locations

US (1)