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

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ClinicalTrials.gov Identifier: NCT02153359
Recruitment Status : Recruiting
First Posted : June 3, 2014
Last Update Posted : December 7, 2018
Sponsor:
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 their 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. They will receive either true air cleaners or sham cleaners in a blinded, randomized manner for one month, and then, after a washout period, they will cross over and receive the other intervention (sham or true cleaner). All participants will have environmental monitoring (personal and in-home) to determine their 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, airway hyperresponsiveness, systemic markers of inflammation, and bronchoscopic evidence of airway inflammation or epithelial cell dysfunction. Modifying factors or factors influencing susceptibility, such as diet and nutritional status, will also be explored.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 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
Study Start Date : February 2014
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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, including in-home health questionnaires, symptom-, diet-, and activity- diaries/recalls, blood, urine and exhaled breath testing, repeated measures of home hand-held lung function, and in-clinic pulmonary function testing with broncho-provocation. Participants will wear a light backpack with air monitoring devices during the last week in order to measure their 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 nasal and lower airway sampling will occur under conscious sedation.
Device: High Efficiency Particulate Air Cleaner
Sham Comparator: sham 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, including in-home health questionnaires, symptom-, diet-, and activity- diaries/recalls, blood, urine and exhaled breath testing, repeated measures of home hand-held lung function, and in-clinic pulmonary function testing with broncho-provocation. Participants will wear a light backpack with air monitoring devices during the last week in order to measure their 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 nasal and lower airway sampling will occur under conscious sedation.
Device: Sham air cleaner



Primary Outcome Measures :
  1. Asthma morbidity [ Time Frame: Approximately 3 months ]
    Asthma morbidity will be assessed by reports of health-care utilization, need for pharmacotherapy, and respiratory symptoms at two distinct intervention periods, while receiving sham and true air cleaners. Changes in respiratory symptoms will be assessed by self-reports in symptoms questionnaires and diaries.


Secondary Outcome Measures :
  1. Pulmonary Function: Spirometry [ Time Frame: Approximately 3 months ]
    Pulmonary function will be assessed by spirometry. We will obtain values of FEV1, FVC, FEV1/FVC ratio, and FEF25/75.

  2. Bronchoreactivity to Mannitol Challenge [ Time Frame: Approximately 3 months ]
    Bronchoreactivity will be defined according to the decrease in forced expiratory volume at 1 second (FEV1) following administration of mannitol.

  3. Biomarkers of inflammation and immune status [ Time Frame: Approximately 3 months ]
    Biomarkers indicating changes in individual inflammatory and immune status (e.g. cytokines, exhaled NO, hematologic cell counts, etc) in blood, urine, exhaled breath and samples from the upper and lower airways will be analyzed with respect to the change in pollution (e.g. particulate matter) that each participant is exposed to in each arm of the study.

  4. Intake and individual status of a variety of micro and macronutrients [ Time Frame: Approximately 3 months ]
    Effect modifiers, such as diet, nutritional factors, and measures of obesity will also be explored in these analyses.



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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


Contacts
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Contact: Kim Ladson, CO MA 410-550-2708 kladson1@jhmi.edu

Locations
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United States, Maryland
Johns Hopkins Bayview Medical Center Recruiting
Baltimore, Maryland, United States, 21224
Contact: Kim Ladson, CO MA    410-550-2708    kladson1@jhmi.edu   
Principal Investigator: Sonali Bose, MD MPH         
Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21287
Contact: Kim Ladson, CO MA    410-550-2708    kladson1@jhmi.edu   
Principal Investigator: Sonali Bose, MD MPH         
Sponsors and Collaborators
Johns Hopkins University
Investigators
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Principal Investigator: Sonali Bose, MD MPH Johns Hopkins University

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02153359     History of Changes
Other Study ID Numbers: NA_00082646
First Posted: June 3, 2014    Key Record Dates
Last Update Posted: December 7, 2018
Last Verified: December 2018

Keywords provided by Johns Hopkins University:
asthma
HEPA
air pollutants
lung function
home environment
respiratory symptoms
diet