Effects of Reducing Indoor Air Pollution on the Adult Asthmatic Response

Asthma Clinical Trial

— INHALE 2  

Official title:

Effects of Reducing Indoor Air Pollution on the Adult Asthmatic Response

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02153359
• Other study ID #: NA_00082646
• Secondary ID: 1K24ES021098-01K
• Status: Completed
• Phase: N/A
• Start date: February 2014
• Est. completion date: September 11, 2018

Study information

• Verified date: August 2019
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: September 11, 2018
• Est. primary completion date: September 11, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

Device:
• High Efficiency Particulate Air Cleaner

• Sham air cleaner

Locations

Country	Name	City	State
United States	Johns Hopkins Bayview Medical Center	Baltimore	Maryland
United States	Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute of Environmental Health Sciences (NIEHS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	Number of Days With Activity Limitations	Number of reported days with activity limitations due to asthma symptoms.	7 days
Secondary	Number of Nights Disrupted by Asthma Symptoms	The number of nights spent sleeping that was disrupted due to asthma symptoms.	7 nights
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Bronchoalveolar Lavage Differential Neutrophil Count	The percentage of neutrophils in the bronchoalveolar lavage cell count.	1 Day
Secondary	Bronchoalveolar Lavage Differential Eosinophil Count	The eosinophil percentage in the bronchoalveolar lavage cell count differential.	1 day
Secondary	Pre-bronchodilator Forced Vital Capacity (Litres)	Pre-bronchodilator forced vital capacity (FVC) as assessed with spirometry	1 day
Secondary	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
Secondary	FEV1 Percentage of FVC	The pre-bronchodilator forced expiratory volume in 1 second over the forced vital capacity as assessed by spirometry.	1 day