Asthma and Indoor-air: Reducing Exposures

NCT ID: NCT01869543

Last Updated: 2019-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 219 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2017-02-08

Brief Summary

Two hundred moderate to severely asthmatic children (6-12 years) will be enrolled in a study to look at the effectiveness of high efficiency filtration of indoor air in homes on reducing asthma symptoms. One intervention group will have high efficiency filters or filtration systems installed in their central heating and air conditioning (HVAC) system. The second intervention group will have high efficiency portable air cleaners placed in the child's bedroom and in the main living area. Each participant will receive true air filtration for a year and a placebo for a year. During the placebo period a sham filter will be used that removes very little of the particles. Measures of health effects will include days of symptoms, unplanned utilization of the healthcare system for asthma-related illness, short-term medication use, peak exhaled flow, spirometry, and exhaled nitric oxide (eNO).

Conditions

Asthma

Study Design

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

Study Groups

Stand Alone Air Cleaner-True/Sham

The participant will have stand alone air cleaners placed in their home. They will have true filtration followed by sham filtration.

Group Type: EXPERIMENTAL

Stand Alone Air Cleaner

Intervention Type: OTHER

This is an environmental intervention using a stand alone air cleaner designed to reduce the air pollution levels in the home.

Stand Alone Air Cleaner-Sham/True

Participants will have stand alone air cleaners placed in their homes. They will begin with sham filtration.

Group Type: EXPERIMENTAL

Stand Alone Air Cleaner

Intervention Type: OTHER

This is an environmental intervention using a stand alone air cleaner designed to reduce the air pollution levels in the home.

HVAC modification-True/Sham

Participants will have their HVAC system modified to include high efficiency filtration. They will begin true filtration followed by sham filtration.

Group Type: EXPERIMENTAL

HVAC Modification

Intervention Type: OTHER

This is an environmental intervention that modifies the home HVAC system to include high efficiency air filtration designed to reduce the air pollution levels in the home.

HVAC Modification-Sham/True

Participants will have their HVAC system modified to include high efficiency filtration. They will begin sham filtration.

Group Type: EXPERIMENTAL

HVAC Modification

Intervention Type: OTHER

This is an environmental intervention that modifies the home HVAC system to include high efficiency air filtration designed to reduce the air pollution levels in the home.

Interventions

Stand Alone Air Cleaner

This is an environmental intervention using a stand alone air cleaner designed to reduce the air pollution levels in the home.

Intervention Type: OTHER

HVAC Modification

This is an environmental intervention that modifies the home HVAC system to include high efficiency air filtration designed to reduce the air pollution levels in the home.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 6-12 years of age
• Living in Fresno, San Bernardino or Riverside Counties.
• Physician diagnosed asthma, as stated by the participant's caregiver.
• In the last six months, the child must have had asthma symptoms at least twice a week for several weeks in a row.

Exclusion Criteria

• Children living in homes where more than 2 cigarettes are smoked per week in the home.
• Children that spend 2 or more nights per week in another home.
• Children living in homes that are planning on moving in the next 2 years.
• Children living in homes that keep their windows open most of the time.
• Children living in homes that have existing high efficiency filtration.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Davis

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Deborah Bennett, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Locations

University of California, Davis- Department of Public Health Sciences

Davis, California, United States

Countries

United States

Other Identifiers

11-324

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

346123

Identifier Type: -

Identifier Source: org_study_id