Effects of Reducing Indoor Air Pollution on the Adult Asthmatic Response (INHALE 2)

Johns Hopkins University

Status: Completed

Conditions: Asthma

Treatments: Device: High Efficiency Particulate Air Cleaner; Device: Sham air cleaner

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02153359

K23ES021789 (U.S. NIH Grant/Contract)

NA_00082646

1K24ES021098-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This study is about asthma and how the environment affects asthma. Scientists know that air pollution (such as cigarette smoke and other particles in the air) can make asthma symptoms worse. This research is being done to study how the health of a person with asthma responds to an air cleaner. The investigator hypothesize that an air cleaner will improve the health of persons with asthma.

Full description

The investigators seek to determine the effect of placing air cleaner devices in the homes of adults with asthma on the adults' asthma health. To this end, the investigators aim to study 40 adults with asthma that are 18-50 years of age and live in Baltimore. Participants will receive either true air cleaners or sham cleaners in a blinded, randomized manner for one month, and then, after a washout period, participants will cross over and receive the other intervention (sham or true cleaner). All participants will have environmental monitoring (personal and in-home) to determine participants' particulate matter exposure, and be followed repeatedly during the 3 month study period for markers of asthma disease, including respiratory symptoms, medication and health care utilization, pulmonary function, systemic markers of inflammation, and bronchoscopic evidence of airway inflammation or epithelial cell dysfunction.

Enrollment: 23 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18-50 years of age
• Non-smoker (<100 cigarettes in lifetime)
• Physician diagnosis of asthma
• Symptoms of asthma and/or reliever medication use in the past 6 months
• Living in the current residence >= 6 months within Baltimore
• Enrollment in, and completion of, the observational environmental asthma study "Inhale 1"

Exclusion criteria

• Current diagnosis of another major pulmonary disease, other significant morbidity
• Pregnancy (as defined by a positive urine pregnancy test at screening of all women of child-bearing potential)
• Planning to relocate residence or activity that necessitates travel away from home for prolonged period of time during the study period
• Current use of an air cleaner in the home

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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23 participants in 2 patient groups

Air cleaner then sham air cleaner

Experimental group

Description:

A High Efficiency Particulate Air Cleaner (HEPA) intervention will be placed in the participant's home for one month. During the last week of the month, health assessments will be conducted, which include in-home health questionnaires, symptom-, and activity- diaries/recalls, blood, and hand-held spirometry. Participants will also be asked to wear a light backpack with air monitoring devices during the course of the day during the last week in order to measure participants' exposures to pollutants. Finally, at the end of the month, participants will be asked to report to the Johns Hopkins outpatient endoscopy suite for bronchoscopy, during which airway sampling will occur under conscious sedation. For the participants who started in the experimental arm, after this one month intervention period, they will then enter a wash-out period where no intervention or outcome measures are undertaken for at least one month prior to cross-over to the sham comparator arm.

Treatment:

Device: High Efficiency Particulate Air Cleaner

Device: Sham air cleaner

Sham air cleaner then air cleaner

Sham Comparator group

Description:

A sham air cleaner will be placed in the participant's home for one month. During the last week of the month, health assessments will be conducted, which include in-home health questionnaires, symptom-, and activity- diaries/recalls, blood, and hand-held spirometry. Participants will also be asked to wear a light backpack with air monitoring devices during the course of the day during the last week in order to measure participants' exposures to pollutants. Finally, at the end of the month, participants will be asked to report to the Johns Hopkins outpatient endoscopy suite for bronchoscopy, during which airway sampling will occur under conscious sedation. For the participants who started in the sham comparator arm, after this one month intervention period, they will then enter a wash-out period where no intervention or outcome measures are undertaken for at least one month prior to cross-over to the experimental arm.

Treatment:

Device: High Efficiency Particulate Air Cleaner

Device: Sham air cleaner