Clinical trial NCT01869543: Asthma and Indoor-air: Reducing Exposures
Official title: Benefits of High Efficiency Filtration to Children With Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2013-06-05
Enrollment: 219
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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).


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.

Primary outcomes:
measure: Days with asthma symptoms
timeFrame: 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)
timeFrame: Measured at 12 months and 24 months
measure: Forced vital capacity, percent predicted (FVC % predicted)
timeFrame: Measured at 12 months and 24 months
measure: Peak Expiratory Flow Rate (PEFR)
timeFrame: Measured at 3, 6, 9, 12, 15, 18, 21, and 24 months
measure: Exhaled NO
timeFrame: Measure at 6, 12, 18, and 24 months
measure: Days of missing school due to asthma
timeFrame: Measured at 3, 6, 9, 12, 15, 18, 21, and 24 months
measure: Days of missing work for parents due to child's asthma
timeFrame: Measured at 3, 6, 9, 12, 15, 18, 21, and 24 months
measure: Hospitalizations
timeFrame: Count during 1-year true filtration period and count during 1-year sham filtration period
measure: Emergency Room Visits
timeFrame: Count during 1-year true filtration period and count during 1-year sham filtration period
measure: Unplanned Clinic Visits
timeFrame: Count during 1-year true filtration period and count during 1-year sham filtration period
measure: Unplanned Steroid treatments
timeFrame: Count during 1-year true filtration period and count during 1-year sham filtration period
measure: Mini Pediatric Asthma Quality of Life Questionnaire (MiniPAQLQ)
timeFrame: Measured at 3, 6, 9, 12, 15, 18, 21, and 24 months
measure: Allergy symptoms
timeFrame: Measured at 3, 6, 9, 12, 15, 18, 21, and 24 months
measure: Respiratory disease
timeFrame: Count of incidents of respiratory disease during 1-year true filtration period and count during 1-year sham filtration period
Other outcomes:
Locations:
city: Davis
country: United States
facility: University of California, Davis- Department of Public Health Sciences
state: California
Study officials:
affiliation: University of California, Davis
name: Deborah Bennett, PhD
role: PRINCIPAL_INVESTIGATOR
References: