Multi-Center Clean Air Randomized Controlled Trial in COPD

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
JHSPH Center for Clinical Trials
Study ID
NCT06376994
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Chronic Obstructive Pulmonary Disease (COPD)

Eligibility Criteria

Sex
ALL
Age
40 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.
  • 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.

Study Details

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.

Key Dates

Start date
May 24, 2024
Status verified
Aug 2025
Primary completion
Aug 31, 2029
Completion
Nov 30, 2029

Study Design

Enrollment
770 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Active air cleaner
    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.
  • Sham Comparator: Sham air cleaner
    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.

Primary Outcome Measure

St. George's Respiratory Questionnaire (SGRQ) [ Time Frame: baseline and 3, 6, 9, and 12 months after baseline ]

Central Contacts

Locations (11)

FacilityCityStateZIPSite coordinators
University of Alabama, Lung Health CenterBirminghamAlabama35233
Geneva Avery
[email protected]
205-934-5555
James Michael Wells, MD (PRINCIPAL_INVESTIGATOR)
University of California, Los AngelesLos AngelesCalifornia90095
Tiffany Bina
[email protected]
310-206-1629
Igor Barjaktarevic, MD (PRINCIPAL_INVESTIGATOR)
University of IowaIowa CityIowa52242
Eric Garcia
[email protected]
319-353-8863
Alejandro Comellas, MD (PRINCIPAL_INVESTIGATOR)
Johns HopkinsBaltimoreMaryland21224
Wendy Lorizio
[email protected]
410-510-2449
Maggie Maly
[email protected]
410-550-9527
University of MarylandBaltimoreMaryland21201
Valeriya Rodionova
[email protected]
410-328-2835
William Grier, MD (PRINCIPAL_INVESTIGATOR)
Tidal HealthSalisburyMaryland21801
Sandra Fetko
[email protected]
410-912-6045
Robert Chasse, MD (PRINCIPAL_INVESTIGATOR)
Beth Israel Deaconess Medical CenterBostonMassachusetts02215
Alethea atadika
[email protected]
781-964-8163
Mary Rice, MD (PRINCIPAL_INVESTIGATOR)
University of MichiganAnn ArborMichigan48109
Crystal Cutlip
[email protected]
734-647-6399
Meilan Han, MD (PRINCIPAL_INVESTIGATOR)
Dartmouth HitchcockLebanonNew Hampshire03756
Athena Fowler
[email protected]
603-650-0567
Laura Paulin, MD (PRINCIPAL_INVESTIGATOR)
Cleveland ClinicClevelandOhio44195
Elena Engel
[email protected]
224-235-8363
Russel Bowler, MD (PRINCIPAL_INVESTIGATOR)
Reading HospitalWest ReadingPennsylvania19611
Pamela marrero
[email protected]
484-628-8355
Luis Murillo, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Birmingham, AL

By research site
University of Alabama, Lung Health Center· Birmingham, ALUniversity of California, Los Angeles· Los Angeles, CAUniversity of Iowa· Iowa City, IAJohns Hopkins· Baltimore, MDUniversity of Maryland· Baltimore, MDTidal Health· Salisbury, MD

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