Residential Cleaning of Indoor Air to Protect COPD Patients

NCT ID: NCT03750292

Last Updated: 2022-06-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-18
• Study Completion Date: 2021-03-26

Brief Summary

This study looks at whether air cleaning devices put in the bedroom and living room of your home could reduce the irritation of your lungs and body that is caused by indoor air pollution. While participating in this study there will be two, 2 month long study segments (Study Period 1 and Study Period 2) where the air filter units, placed in your living room and bedroom windows, will be turned on at your home.

Conditions

Chronic Obstructive Pulmonary Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

HEPAirX air filter

Group Type: EXPERIMENTAL

HEPAirX air filter

Intervention Type: DEVICE

It is a trademarked, patented (U.S. Patent # 7,802,443), U.S. FDA approved Class II medical re-circulating air cleaner, built by Air Innovations, Inc. (North Syracuse, NY) to provide improved indoor air quality in the bedrooms of asthmatic children. Units to be used in the proposed study have a 99.97% efficient filter for particles 0.3 µm in size. The device provides a clean air delivery rate (CADR) of 9 per hour with 1.8 of them being outdoor air.

Control air filter

Group Type: PLACEBO_COMPARATOR

control air filter

Intervention Type: DEVICE

A placebo mode was added to the HEPAirX to provide only recirculation (without filtration or ventilation using outdoor air) and temperature control of the room air. The placebo filter is made of metal.

Interventions

HEPAirX air filter

It is a trademarked, patented (U.S. Patent # 7,802,443), U.S. FDA approved Class II medical re-circulating air cleaner, built by Air Innovations, Inc. (North Syracuse, NY) to provide improved indoor air quality in the bedrooms of asthmatic children. Units to be used in the proposed study have a 99.97% efficient filter for particles 0.3 µm in size. The device provides a clean air delivery rate (CADR) of 9 per hour with 1.8 of them being outdoor air.

Intervention Type: DEVICE

control air filter

A placebo mode was added to the HEPAirX to provide only recirculation (without filtration or ventilation using outdoor air) and temperature control of the room air. The placebo filter is made of metal.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• severe COPD (FEV1 < 50%)
• live in Monroe County
• referred for pulmonary rehabilitation
• suffered from an AECOPD in the past year
• have standard sized windows in their bedroom and living room amenable to installation of the HEPAirX® device
• expect to sleep each night of the 4 months (2 months of Period 1, and 2 months of period 2) in either their bedroom or living room for at least 6 hours/night, and not use other air filtering devices during the study

Exclusion Criteria

• under age 18
• smoking at the time of their prior COPD exacerbation
• current smokers
• those who live with an active smoker
• those with an occupation that has a high pollutant exposure (e.g. professional drivers)
• those who already have a home air filtration device (other than basic furnace filter)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Rochester

OTHER

Sponsor Role: lead

Responsible Party

Dan Croft

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Rochester Medical Center

Rochester, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

72609

Identifier Type: -

Identifier Source: org_study_id