Effects of Reducing Indoor Air Pollution on the Adult Asthmatic Response
INHALE 2
3 other identifiers
interventional
23
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable asthma
Started Feb 2014
Longer than P75 for not_applicable asthma
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 21, 2014
CompletedFirst Posted
Study publicly available on registry
June 3, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 11, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 11, 2018
CompletedResults Posted
Study results publicly available
September 12, 2019
CompletedSeptember 12, 2019
August 1, 2019
4.6 years
April 21, 2014
August 20, 2019
August 20, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (13)
Number of Symptom-free Days
7 days
Number of Days With Activity Limitations
7 days
Number of Nights Disrupted by Asthma Symptoms
7 nights
Number of Days of School/Work Missed Due to Asthma Symptoms
7 days
Number of Days of Unscheduled Visits to the Doctor Due to Asthma Symptoms
7 days
- +8 more secondary outcomes
Study Arms (2)
Air cleaner then sham air cleaner
EXPERIMENTALA 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.
Sham air cleaner then air cleaner
SHAM COMPARATORA 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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"
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224, United States
Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Sonali Bose
- Organization
- Johns Hopkins University
Study Officials
- PRINCIPAL INVESTIGATOR
Sonali Bose, MD MPH
Johns Hopkins University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 21, 2014
First Posted
June 3, 2014
Study Start
February 1, 2014
Primary Completion
September 11, 2018
Study Completion
September 11, 2018
Last Updated
September 12, 2019
Results First Posted
September 12, 2019
Record last verified: 2019-08