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

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ClinicalTrials.gov Identifier: NCT02236858
Recruitment Status : Active, not recruiting
First Posted : September 11, 2014
Last Update Posted : June 21, 2019
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Tracking Information
First Submitted Date  ICMJE February 24, 2014
First Posted Date  ICMJE September 11, 2014
Last Update Posted Date June 21, 2019
Actual Study Start Date  ICMJE March 2014
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 28, 2018)
Change in Quality of Life [ Time Frame: Change from baseline and at 6 months post randomization ]
St. George's Respiratory Questionnaire (SGRQ). The total score is from 0 to 100. Higher scores indicate more limitations
Original Primary Outcome Measures  ICMJE
 (submitted: September 10, 2014)
Quality of life [ Time Frame: Change from baseline quality of life at 6 months post randomization ]
St. George's respiratory questionnaire (SGRQ)
Change History Complete list of historical versions of study NCT02236858 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 28, 2018)
  • Health care utilization [ Time Frame: Baseline through end of study (approximately 6 months post-randomization) ]
    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 [ Time Frame: Change from baseline and 3 months post-randomization ]
    Dyspnea will be assessed using the modified medical research Council questionnaire. The total score is from 0 (no dyspnea) to 2 (severe dyspnea).
  • Change in Dyspnea [ Time Frame: Change from baseline and 6 months post-randomization ]
    Dyspnea will be assessed using the modified medical research Council questionnaire. The total score is from 0 (no dyspnea) to 2 (severe dyspnea).
  • Change in Functional status [ Time Frame: Change from baseline and 3 months post randomization ]
    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 [ Time Frame: Change from baseline and 6 months post randomization ]
    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 [ Time Frame: Change from baseline and 3 months post randomization ]
    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 [ Time Frame: Change from baseline and 6 months post randomization ]
    Functional status will be assessed with the 6 minute walk test. We will assess the distance (in meters) covered a time of 6 minutes.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 10, 2014)
  • 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, ED visit or hospitalization.
  • Dypsnea [ Time Frame: change from baseline dyspnea at 6 months post-randomization ]
    Dyspnea will be assesed 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)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Trial of Air Cleaners to Improve Indoor Air Quality and COPD Health
Official Title  ICMJE Clinical Trial of Air Cleaners to Improve Indoor Air Quality and COPD Health
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Other
Condition  ICMJE Chronic Obstructive Pulmonary Disease (COPD)
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Device: Sham HEPA Air Cleaner
  • 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.
    Intervention: Device: HEPA Air Cleaner
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: June 20, 2019)
142
Original Estimated Enrollment  ICMJE
 (submitted: September 10, 2014)
120
Estimated Study Completion Date  ICMJE February 2020
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02236858
Other Study ID Numbers  ICMJE NA_00085617
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Johns Hopkins University
Study Sponsor  ICMJE Johns Hopkins University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Nadia N Hansel, MD, MPH Johns Hopkins University
PRS Account Johns Hopkins University
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP