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| ID | Type | Description | Link |
|---|---|---|---|
| 1U24HL169566-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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This is a multi-center randomized, sham-controlled clinical trial to determine the effectiveness of an air cleaner intervention aimed at improving indoor air quality on reducing COPD exacerbation risk and improving quality of life, functional status, rescue medication use.
The Multi-Center Clean Air Randomized Controlled Trial in COPD (Clean Air) is a multi-center, prospective, randomized, double-blind, sham-controlled trial that will enroll 770 former smokers with COPD over a 4-year period and follow participants at regular intervals for one year. The primary endpoint is respiratory specific quality of life. Secondary endpoints include rate of acute exacerbations, rescue medication use, quality of life, and cost-effectiveness.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active air cleaner | Experimental | The active arm will receive two active air cleaners with high efficiency particulate air (HEPA) filters which remove particulate matter (PM), as well as activated carbon filters to remove Nitrogen Dioxide (NO2) and other trace gases. |
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| Sham air cleaner | Sham Comparator | The sham control treatment arm will receive two 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Air cleaner | Device | The intervention is two active air cleaners with high efficiency particulate air (HEPA) filters which remove PM, as well as activated carbon filters to remove NO2 (and other trace gases). These will be run for a year in a participant's house. |
| Measure | Description | Time Frame |
|---|---|---|
| St. George's Respiratory Questionnaire (SGRQ) | The St. George's Respiratory Questionnaire (SGRQ) is a widely used measure of disease impact as an indicator of disease-specific quality of life. The SGRQ is a disease specific instrument containing 50 items in three subscales (symptoms, activity, and impact). Scores range from 0 to 100, with higher scores indicating more limitations. | baseline and 3, 6, 9, and 12 months after baseline |
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Inclusion criteria
To be eligible, subjects must meet all these criteria:
Exclusion criteria
To be eligible, subjects must not meet any one of these criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stephan Ehrhardt, MD, PhD | Contact | (410) 502-3872 | sehrhar6@jhu.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama, Lung Health Center | Recruiting | Birmingham | Alabama | 35233 | United States |
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| Sham air cleaner | Device | The sham intervention is two 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. These will be run for a year in a participant's house. |
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| University of California, Los Angeles | Recruiting | Los Angeles | California | 90095 | United States |
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| University of Iowa | Recruiting | Iowa City | Iowa | 52242 | United States |
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| University of Maryland | Recruiting | Baltimore | Maryland | 21201 | United States |
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| Johns Hopkins | Recruiting | Baltimore | Maryland | 21224 | United States |
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| Tidal Health | Recruiting | Salisbury | Maryland | 21801 | United States |
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| Beth Israel Deaconess Medical Center | Not yet recruiting | Boston | Massachusetts | 02215 | United States |
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| University of Michigan | Recruiting | Ann Arbor | Michigan | 48109 | United States |
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| Dartmouth Hitchcock | Not yet recruiting | Lebanon | New Hampshire | 03756 | United States |
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| Cleveland Clinic | Not yet recruiting | Cleveland | Ohio | 44195 | United States |
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| Reading Hospital | Recruiting | West Reading | Pennsylvania | 19611 | United States |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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