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

Primary Purpose

Asthma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High Efficiency Particulate Air Cleaner
Sham air cleaner
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Asthma focused on measuring asthma, HEPA, air pollutants, lung function, home environment, respiratory symptoms

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Johns Hopkins Bayview Medical Center
  • Johns Hopkins Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Air cleaner then sham air cleaner

Sham air cleaner then air cleaner

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

PM2.5 Concentration (ug/m^3)
Fine particulate matter (PM2.5) concentration as assessed by a passive filter placed in the participant's home.
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.

Secondary Outcome Measures

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.
Number of Days With Activity Limitations
Number of reported days with activity limitations due to asthma symptoms.
Number of Nights Disrupted by Asthma Symptoms
The number of nights spent sleeping that was disrupted due to asthma symptoms.
Number of Days of School/Work Missed Due to Asthma Symptoms
The number of days of school or work missed due to asthma symptoms.
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.
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).
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.
Air Nicotine Concentration (ug/m^3)
Indoor air nicotine concentration as assessed by a passive filter placed in the participant's home.
Bronchoalveolar Lavage Differential Neutrophil Count
The percentage of neutrophils in the bronchoalveolar lavage cell count.
Bronchoalveolar Lavage Differential Eosinophil Count
The eosinophil percentage in the bronchoalveolar lavage cell count differential.
Pre-bronchodilator Forced Vital Capacity (Litres)
Pre-bronchodilator forced vital capacity (FVC) as assessed with spirometry
Pre-bronchodilator Forced Expiratory Volume in 1 Second (Litres)
The pre-bronchodilator forced expiratory volume in 1 second (FEV1) as assessed by spirometry.
FEV1 Percentage of FVC
The pre-bronchodilator forced expiratory volume in 1 second over the forced vital capacity as assessed by spirometry.

Full Information

First Posted
April 21, 2014
Last Updated
August 20, 2019
Sponsor
Johns Hopkins University
Collaborators
National Institute of Environmental Health Sciences (NIEHS)
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1. Study Identification

Unique Protocol Identification Number
NCT02153359
Brief Title
Effects of Reducing Indoor Air Pollution on the Adult Asthmatic Response
Acronym
INHALE 2
Official Title
Effects of Reducing Indoor Air Pollution on the Adult Asthmatic Response
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
February 2014 (Actual)
Primary Completion Date
September 11, 2018 (Actual)
Study Completion Date
September 11, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
National Institute of Environmental Health Sciences (NIEHS)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
asthma, HEPA, air pollutants, lung function, home environment, respiratory symptoms

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Air cleaner then sham air cleaner
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham air cleaner then air cleaner
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
High Efficiency Particulate Air Cleaner
Intervention Type
Device
Intervention Name(s)
Sham air cleaner
Primary Outcome Measure Information:
Title
PM2.5 Concentration (ug/m^3)
Description
Fine particulate matter (PM2.5) concentration as assessed by a passive filter placed in the participant's home.
Time Frame
Approximately 1 month
Title
PM2.5-10 Concentration (ug/m^3)
Description
Coarse particulate matter (PM2.5-10) concentration as assessed by a passive filter placed in the participant's home.
Time Frame
Approximately 1 month
Secondary Outcome Measure Information:
Title
Number of Symptom-free Days
Description
The number of reported days without daytime asthma symptoms (symptom-free days) as based on daily symptom diaries recorded by the patient.
Time Frame
7 days
Title
Number of Days With Activity Limitations
Description
Number of reported days with activity limitations due to asthma symptoms.
Time Frame
7 days
Title
Number of Nights Disrupted by Asthma Symptoms
Description
The number of nights spent sleeping that was disrupted due to asthma symptoms.
Time Frame
7 nights
Title
Number of Days of School/Work Missed Due to Asthma Symptoms
Description
The number of days of school or work missed due to asthma symptoms.
Time Frame
7 days
Title
Number of Days of Unscheduled Visits to the Doctor Due to Asthma Symptoms
Description
The number of days of unscheduled, urgent visits to the office, urgent care or emergency department due to asthma symptoms.
Time Frame
7 days
Title
Asthma Disease Status as Assessed by the Asthma Control and Communication Instrument (ACCI)
Description
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).
Time Frame
Approximately 1 month
Title
Asthma-specific Health-related Quality of Life as Assessed by the Asthma Quality of Life Questionnaire (AQLQ)
Description
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.
Time Frame
Approximately 1 month
Title
Air Nicotine Concentration (ug/m^3)
Description
Indoor air nicotine concentration as assessed by a passive filter placed in the participant's home.
Time Frame
Approximately 1 month
Title
Bronchoalveolar Lavage Differential Neutrophil Count
Description
The percentage of neutrophils in the bronchoalveolar lavage cell count.
Time Frame
1 Day
Title
Bronchoalveolar Lavage Differential Eosinophil Count
Description
The eosinophil percentage in the bronchoalveolar lavage cell count differential.
Time Frame
1 day
Title
Pre-bronchodilator Forced Vital Capacity (Litres)
Description
Pre-bronchodilator forced vital capacity (FVC) as assessed with spirometry
Time Frame
1 day
Title
Pre-bronchodilator Forced Expiratory Volume in 1 Second (Litres)
Description
The pre-bronchodilator forced expiratory volume in 1 second (FEV1) as assessed by spirometry.
Time Frame
1 day
Title
FEV1 Percentage of FVC
Description
The pre-bronchodilator forced expiratory volume in 1 second over the forced vital capacity as assessed by spirometry.
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sonali Bose, MD MPH
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Bayview Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States

12. IPD Sharing Statement

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Effects of Reducing Indoor Air Pollution on the Adult Asthmatic Response

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