Clinical trial NCT02153359: Effects of Reducing Indoor Air Pollution on the Adult Asthmatic Response
Official title: Effects of Reducing Indoor Air Pollution on the Adult Asthmatic Response
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: asthma
HEPA
air pollutants
lung function
home environment
respiratory symptoms
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute of Environmental Health Sciences (NIEHS)
First posted: 2014-06-03
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: PM2.5 Concentration (ug/m^3)
timeFrame: Approximately 1 month
measure: PM2.5-10 Concentration (ug/m^3)
timeFrame: Approximately 1 month
Secondary outcomes:
measure: Number of Symptom-free Days
timeFrame: 7 days
measure: Number of Days With Activity Limitations
timeFrame: 7 days
measure: Number of Nights Disrupted by Asthma Symptoms
timeFrame: 7 nights
measure: Number of Days of School/Work Missed Due to Asthma Symptoms
timeFrame: 7 days
measure: Number of Days of Unscheduled Visits to the Doctor Due to Asthma Symptoms
timeFrame: 7 days
measure: Asthma Disease Status as Assessed by the Asthma Control and Communication Instrument (ACCI)
timeFrame: Approximately 1 month
measure: Asthma-specific Health-related Quality of Life as Assessed by the Asthma Quality of Life Questionnaire (AQLQ)
timeFrame: Approximately 1 month
measure: Air Nicotine Concentration (ug/m^3)
timeFrame: Approximately 1 month
measure: Bronchoalveolar Lavage Differential Neutrophil Count
timeFrame: 1 Day
measure: Bronchoalveolar Lavage Differential Eosinophil Count
timeFrame: 1 day
measure: Pre-bronchodilator Forced Vital Capacity (Litres)
timeFrame: 1 day
measure: Pre-bronchodilator Forced Expiratory Volume in 1 Second (Litres)
timeFrame: 1 day
measure: FEV1 Percentage of FVC
timeFrame: 1 day
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Bayview Medical Center
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Sonali Bose, MD MPH
role: PRINCIPAL_INVESTIGATOR
References: