Effects of Reducing Indoor Air Pollution on the Adult Asthmatic Response

NCT ID: NCT02153359

Last Updated: 2019-09-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2018-09-11

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.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

High Efficiency Particulate Air Cleaner

Intervention Type: DEVICE

Sham air cleaner

Intervention Type: DEVICE

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.

Group Type: SHAM_COMPARATOR

High Efficiency Particulate Air Cleaner

Intervention Type: DEVICE

Sham air cleaner

Intervention Type: DEVICE

Interventions

High Efficiency Particulate Air Cleaner

Intervention Type: DEVICE

Sham air cleaner

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Environmental Health Sciences (NIEHS)

NIH

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sonali Bose, MD MPH

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, United States

Johns Hopkins Hospital

Baltimore, Maryland, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1K24ES021098-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

K23ES021789

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NA_00082646

Identifier Type: -

Identifier Source: org_study_id