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

This study is currently recruiting participants.
Verified September 2017 by Johns Hopkins University
Sponsor:
ClinicalTrials.gov Identifier:
NCT02236858
First Posted: September 11, 2014
Last Update Posted: October 3, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Johns Hopkins University
  Purpose

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.


Condition Intervention
Chronic Obstructive Pulmonary Disease (COPD) Device: HEPA Air Cleaner Device: Sham HEPA Air Cleaner

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Other
Official Title: Clinical Trial of Air Cleaners to Improve Indoor Air Quality and COPD Health

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Quality of life [ Time Frame: Change from baseline quality of life at 6 months post randomization ]
    St. George's respiratory questionnaire (SGRQ)


Secondary Outcome Measures:
  • Health care utilization [ Time Frame: Participants will be followed for 6 months post-randomization. During this 6 months exacerbations will be collected at monthly telephone calls and at 3 and 6 month clinic visits. Whether an exacerbation occured over this 6 month period will be assessed ]
    Exacerbations including need for oral corticosteroids or antibiotics for worsening respiratory symptoms, emergency department (ED) visit or hospitalization.

  • Dyspnea [ Time Frame: change from baseline dyspnea at 6 months post-randomization ]
    Dyspnea will be assessed using the modified medical research council questionnaire

  • Functional status [ Time Frame: Change from baseline functional status at 6 months post randomization ]
    Functional status will be assessed with the COPD assessment test (CAT)


Estimated Enrollment: 120
Actual Study Start Date: March 2014
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: June 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥ 40 years,
  2. Physician diagnosis of COPD,
  3. GOLD Stage II-IV disease with FEV1/FVC ≤70% and FEV1 (% predicted) <80%,
  4. Tobacco exposure ≥ 10 pack-years, and
  5. 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:

  1. Chronic systemic corticosteroids (≥ 3 months continuous use in past 12 months),
  2. Other chronic lung disease including asthma,
  3. Living in location other than home (e.g., long term care facility) and
  4. Home owner or home occupant planning to move or change residence within the study period.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02236858


Contacts
Contact: Teresa L. Concordia 410-550-2449 tconcor1@jhmi.edu
Contact: Lilian Arteaga 410-550-9527 larteag1@jhmi.edu

Locations
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21224
Contact: Lilian Arteaga    410-550-9527    larteag1@jhmi.eduedu   
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Nadia N Hansel, MD, MPH Johns Hopkins University
  More Information

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02236858     History of Changes
Other Study ID Numbers: NA_00085617
First Submitted: February 24, 2014
First Posted: September 11, 2014
Last Update Posted: October 3, 2017
Last Verified: September 2017

Keywords provided by Johns Hopkins University:
COPD

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases