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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02153359
Recruitment Status : Completed
First Posted : June 3, 2014
Results First Posted : September 12, 2019
Last Update Posted : September 12, 2019
Sponsor:
Collaborator:
National Institute of Environmental Health Sciences (NIEHS)
Information provided by (Responsible Party):
Johns Hopkins University

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.

Condition or disease Intervention/treatment Phase
Asthma Device: High Efficiency Particulate Air Cleaner Device: Sham air cleaner Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Effects of Reducing Indoor Air Pollution on the Adult Asthmatic Response
Actual Study Start Date : February 2014
Actual Primary Completion Date : September 11, 2018
Actual Study Completion Date : September 11, 2018

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. PM2.5 Concentration (ug/m^3) [ Time Frame: Approximately 1 month ]
    Fine particulate matter (PM2.5) concentration as assessed by a passive filter placed in the participant's home.

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


Secondary Outcome Measures :
  1. Number of Symptom-free Days [ Time Frame: 7 days ]
    The number of reported days without daytime asthma symptoms (symptom-free days) as based on daily symptom diaries recorded by the patient.

  2. Number of Days With Activity Limitations [ Time Frame: 7 days ]
    Number of reported days with activity limitations due to asthma symptoms.

  3. Number of Nights Disrupted by Asthma Symptoms [ Time Frame: 7 nights ]
    The number of nights spent sleeping that was disrupted due to asthma symptoms.

  4. Number of Days of School/Work Missed Due to Asthma Symptoms [ Time Frame: 7 days ]
    The number of days of school or work missed due to asthma symptoms.

  5. Number of Days of Unscheduled Visits to the Doctor Due to Asthma Symptoms [ Time Frame: 7 days ]
    The number of days of unscheduled, urgent visits to the office, urgent care or emergency department due to asthma symptoms.

  6. Asthma Disease Status as Assessed by the Asthma Control and Communication Instrument (ACCI) [ Time Frame: Approximately 1 month ]
    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).

  7. Asthma-specific Health-related Quality of Life as Assessed by the Asthma Quality of Life Questionnaire (AQLQ) [ Time Frame: Approximately 1 month ]
    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.

  8. Air Nicotine Concentration (ug/m^3) [ Time Frame: Approximately 1 month ]
    Indoor air nicotine concentration as assessed by a passive filter placed in the participant's home.

  9. Bronchoalveolar Lavage Differential Neutrophil Count [ Time Frame: 1 Day ]
    The percentage of neutrophils in the bronchoalveolar lavage cell count.

  10. Bronchoalveolar Lavage Differential Eosinophil Count [ Time Frame: 1 day ]
    The eosinophil percentage in the bronchoalveolar lavage cell count differential.

  11. Pre-bronchodilator Forced Vital Capacity (Litres) [ Time Frame: 1 day ]
    Pre-bronchodilator forced vital capacity (FVC) as assessed with spirometry

  12. Pre-bronchodilator Forced Expiratory Volume in 1 Second (Litres) [ Time Frame: 1 day ]
    The pre-bronchodilator forced expiratory volume in 1 second (FEV1) as assessed by spirometry.

  13. FEV1 Percentage of FVC [ Time Frame: 1 day ]
    The pre-bronchodilator forced expiratory volume in 1 second over the forced vital capacity as assessed by spirometry.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02153359


Locations
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United States, Maryland
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
National Institute of Environmental Health Sciences (NIEHS)
Investigators
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Principal Investigator: Sonali Bose, MD MPH Johns Hopkins University
  Study Documents (Full-Text)

Documents provided by Johns Hopkins University:
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02153359    
Other Study ID Numbers: NA_00082646
1K24ES021098-01 ( U.S. NIH Grant/Contract )
K23ES021789 ( U.S. NIH Grant/Contract )
First Posted: June 3, 2014    Key Record Dates
Results First Posted: September 12, 2019
Last Update Posted: September 12, 2019
Last Verified: August 2019
Keywords provided by Johns Hopkins University:
asthma
HEPA
air pollutants
lung function
home environment
respiratory symptoms
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases