Overview

This trial is active, not recruiting.

Condition asthma
Treatments stand alone air cleaner, hvac modification
Sponsor Deborah Bennett,PhD
Start date November 2013
End date October 2016
Trial size 200 participants
Trial identifier NCT01869543, 11-324, 346123

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model crossover assignment
Masking double blind (subject, caregiver)
Arm
(Experimental)
The participant will have stand alone air cleaners placed in their home. They will have true filtration followed by sham filtration.
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.
(Experimental)
Participants will have stand alone air cleaners placed in their homes. They will begin with sham filtration.
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.
(Experimental)
Participants will have their HVAC system modified to include high efficiency filtration. They will begin true filtration followed by sham filtration.
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.
(Experimental)
Participants will have their HVAC system modified to include high efficiency filtration. They will begin sham filtration.
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.

Primary Outcomes

Measure
Days with asthma symptoms
time frame: Measured at 3, 6, 9, 12, 15, 18, 21, and 24 months

Secondary Outcomes

Measure
Forced expiratory volume at one second, percent predicted (FEV1 % predicted)
time frame: Measured at 12 months and 24 months
Forced vital capacity, percent predicted (FVC % predicted)
time frame: Measured at 12 months and 24 months
Peak Expiratory Flow Rate (PEFR)
time frame: Measured at 3, 6, 9, 12, 15, 18, 21, and 24 months
Exhaled NO
time frame: Measure at 6, 12, 18, and 24 months
Days of missing school due to asthma
time frame: Measured at 3, 6, 9, 12, 15, 18, 21, and 24 months
Days of missing work for parents due to child's asthma
time frame: Measured at 3, 6, 9, 12, 15, 18, 21, and 24 months
Hospitalizations
time frame: Count during 1-year true filtration period and count during 1-year sham filtration period
Emergency Room Visits
time frame: Count during 1-year true filtration period and count during 1-year sham filtration period
Unplanned Clinic Visits
time frame: Count during 1-year true filtration period and count during 1-year sham filtration period
Unplanned Steroid treatments
time frame: Count during 1-year true filtration period and count during 1-year sham filtration period
Mini Pediatric Asthma Quality of Life Questionnaire (MiniPAQLQ)
time frame: Measured at 3, 6, 9, 12, 15, 18, 21, and 24 months
Allergy symptoms
time frame: Measured at 3, 6, 9, 12, 15, 18, 21, and 24 months
Respiratory disease
time frame: Count of incidents of respiratory disease during 1-year true filtration period and count during 1-year sham filtration period

Eligibility Criteria

Male or female participants from 6 years up to 12 years old.

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.

Additional Information

Official title Benefits of High Efficiency Filtration to Children With Asthma
Principal investigator Deborah Bennett, PhD
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University of California, Davis.