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

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.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Device: High Efficiency Particulate Air Cleaner; Device: Sham air cleaner

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins Hospital
    • Baltimore, Maryland, United States, 21224
      • Johns Hopkins Bayview Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Air cleaner then sham air cleaner; 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.	Device: High Efficiency Particulate Air Cleaner; Device: Sham air cleaner
Sham Comparator: Sham air cleaner then air cleaner; 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.	Device: High Efficiency Particulate Air Cleaner; Device: Sham air cleaner

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PM2.5 Concentration (ug/m^3)	Fine particulate matter (PM2.5) concentration as assessed by a passive filter placed in the participant's home.	Approximately 1 month
PM2.5-10 Concentration (ug/m^3)	Coarse particulate matter (PM2.5-10) concentration as assessed by a passive filter placed in the participant's home.	Approximately 1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Symptom-free Days	The number of reported days without daytime asthma symptoms (symptom-free days) as based on daily symptom diaries recorded by the patient.	7 days
Number of Days With Activity Limitations	Number of reported days with activity limitations due to asthma symptoms.	7 days
Number of Nights Disrupted by Asthma Symptoms	The number of nights spent sleeping that was disrupted due to asthma symptoms.	7 nights
Number of Days of School/Work Missed Due to Asthma Symptoms	The number of days of school or work missed due to asthma symptoms.	7 days
Number of Days of Unscheduled Visits to the Doctor Due to Asthma Symptoms	The number of days of unscheduled, urgent visits to the office, urgent care or emergency department due to asthma symptoms.	7 days
Asthma Disease Status as Assessed by the Asthma Control and Communication Instrument (ACCI)	The ACCI is a validated clinical tool that measures asthma disease status during routine health care and is valid for use in both black and white populations. The sum of each of the 5 ACCI asthma control domains results in a final ACCI score ranging from 0 (better control) to 19 (worse control).	Approximately 1 month
Asthma-specific Health-related Quality of Life as Assessed by the Asthma Quality of Life Questionnaire (AQLQ)	The AQLQ is validated clinical tool to assess asthma-specific health-related quality of life instrument that taps both physical and emotional impact of disease. Scores range from 1-7, with higher scores indicating better quality of life.	Approximately 1 month
Air Nicotine Concentration (ug/m^3)	Indoor air nicotine concentration as assessed by a passive filter placed in the participant's home.	Approximately 1 month
Bronchoalveolar Lavage Differential Neutrophil Count	The percentage of neutrophils in the bronchoalveolar lavage cell count.	1 Day
Bronchoalveolar Lavage Differential Eosinophil Count	The eosinophil percentage in the bronchoalveolar lavage cell count differential.	1 day
Pre-bronchodilator Forced Vital Capacity (Litres)	Pre-bronchodilator forced vital capacity (FVC) as assessed with spirometry	1 day
Pre-bronchodilator Forced Expiratory Volume in 1 Second (Litres)	The pre-bronchodilator forced expiratory volume in 1 second (FEV1) as assessed by spirometry.	1 day
FEV1 Percentage of FVC	The pre-bronchodilator forced expiratory volume in 1 second over the forced vital capacity as assessed by spirometry.	1 day

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: National Institute of Environmental Health Sciences (NIEHS)
• Investigators: Principal Investigator: Sonali Bose, MD MPH, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2014
• Primary Completion (Actual): September 11, 2018
• Study Completion (Actual): September 11, 2018

Study Registration Dates

• First Submitted: April 21, 2014
• First Submitted That Met QC Criteria: May 29, 2014
• First Posted (Estimate): June 3, 2014

Study Record Updates

• Last Update Posted (Actual): September 12, 2019
• Last Update Submitted That Met QC Criteria: August 20, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: lung function; asthma; home environment; HEPA; respiratory symptoms; air pollutants
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: NA_00082646; 1K24ES021098-01 (U.S. NIH Grant/Contract); K23ES021789 (U.S. NIH Grant/Contract)