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Asthma and Indoor-air: Reducing Exposures (AIRE)

Primary Purpose

Asthma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stand Alone Air Cleaner
HVAC Modification
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Asthma

Eligibility Criteria

6 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of California, Davis- Department of Public Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Stand Alone Air Cleaner-True/Sham

Stand Alone Air Cleaner-Sham/True

HVAC modification-True/Sham

HVAC Modification-Sham/True

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Days with asthma symptoms
The maximum number of days with symptoms, from a two-week recall period, will be determined every three months. The maximum number of days with symptoms will be defined as the largest value among the following three variables: (i) number of days with wheezing, tightness in the chest, or cough because of asthma, (ii) number of days that the child had to slow down or stop his/her play or activities because of asthma, wheezing or tightness in the chest, or cough, or (iii) number of nights that the child woke up because of asthma, wheezing or tightness in the chest, or cough. The seasonally adjusted mean difference in the number of symptom days between the true and sham filtration periods will be estimated using generalized linear mixed-effects regression models.

Secondary Outcome Measures

Forced expiratory volume at one second, percent predicted (FEV1 % predicted)
Lung function will be assessed using FEV1 % predicted. The adjusted mean difference in the FEV1% predicted between the true and sham filtration periods will be estimated using generalized linear mixed-effects regression models.
Forced vital capacity, percent predicted (FVC % predicted)
Lung function will be assessed using FVC % predicted. The adjusted mean difference in the FVC% predicted between the true and sham filtration periods will be estimated using generalized linear mixed-effects regression models.
Peak Expiratory Flow Rate (PEFR)
Lung function will be assessed using morning peak expiratory flow rate (PEFR), averaged for all days over one-week testing periods. The seasonally adjusted mean difference in the PERF measure between the true and sham filtration periods will be estimated using generalized linear mixed-effects regression models.
Exhaled NO
The seasonally adjusted mean difference in the Exhaled NO between the true and sham filtration periods will be estimated using generalized linear mixed-effects regression models.
Days of missing school due to asthma
Days of missing school due to asthma will be expressed as a proportion of days of missing school versus the total number of school days during a two-week period. The seasonally adjusted mean difference in the proportion of missed school days between the true and sham filtration periods will be estimated using generalized linear mixed-effects regression models.
Days of missing work for parents due to child's asthma
Days of missing work due to child's asthma will be expressed as a proportion of days of missing work versus the total number of work days during a two-week period. The seasonally adjusted mean difference in the proportion of missed work days between the true and sham filtration periods will be estimated using generalized linear mixed-effects regression models.
Hospitalizations
The number of overnight hospitalizations due to asthma will be assessed every 3 months during real and sham periods. Participants will report number of overnight hospitalizations due to asthma that occurred in the previous three months. The adjusted mean hospitalization incidence ratio between the true and sham filtration periods will be compared using mixed-effects Poison regression models.
Emergency Room Visits
The number of emergency room visits due to asthma will be assessed every 3 months during real and sham periods. Participants will report number of emergency room visits due to asthma that occurred in the previous three months. The adjusted mean emergency room visit incidence ratio between the true and sham filtration periods will be compared using generalized mixed-effects regression models.
Unplanned Clinic Visits
The number of unplanned clinic visits due to asthma will be assessed every 3 months during real and sham periods. Participants will report number of unplanned clinic visits due to asthma that occurred in the previous three months. The adjusted mean unplanned clinic visit incidence ratio between the true and sham filtration periods will be compared using generalized mixed-effects regression models.
Unplanned Steroid treatments
The number of unplanned steroid treatments due to asthma will be assessed every 3 months during real and sham periods. Participants will report number of unplanned steroid treatments due to asthma that occurred in the previous three months. The adjusted mean unplanned steroid treatment incidence ratio between the true and sham filtration periods will be compared using generalized mixed-effects regression models.
Mini Pediatric Asthma Quality of Life Questionnaire (MiniPAQLQ)
The MiniPAQLQ has three composite domains, symptoms, emotional function, and activity limitation, each of which will be analyzed separately. The seasonally adjusted mean difference in each domain score between the true and sham filtration periods will be estimated using generalized linear mixed-effects regression models.
Allergy symptoms
Allergy symptoms during two week recall periods will be summarized into a composite score. The seasonally adjusted mean difference in the scores between the true and sham filtration periods will be using generalized linear mixed-effects regression models.
Respiratory disease
The number of incidents of respiratory disease will be assessed every 3 months during real and sham periods. Participants will report number of incidents of respiratory disease that occurred in the previous three months. The adjusted mean respiratory disease incidence ratio between the true and sham filtration periods will be compared using generalized mixed-effects regression models.

Full Information

First Posted
April 3, 2013
Last Updated
March 19, 2019
Sponsor
University of California, Davis
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1. Study Identification

Unique Protocol Identification Number
NCT01869543
Brief Title
Asthma and Indoor-air: Reducing Exposures
Acronym
AIRE
Official Title
Benefits of High Efficiency Filtration to Children With Asthma
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
July 2012 (Actual)
Primary Completion Date
February 8, 2017 (Actual)
Study Completion Date
February 8, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
219 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stand Alone Air Cleaner-True/Sham
Arm Type
Experimental
Arm Description
The participant will have stand alone air cleaners placed in their home. They will have true filtration followed by sham filtration.
Arm Title
Stand Alone Air Cleaner-Sham/True
Arm Type
Experimental
Arm Description
Participants will have stand alone air cleaners placed in their homes. They will begin with sham filtration.
Arm Title
HVAC modification-True/Sham
Arm Type
Experimental
Arm Description
Participants will have their HVAC system modified to include high efficiency filtration. They will begin true filtration followed by sham filtration.
Arm Title
HVAC Modification-Sham/True
Arm Type
Experimental
Arm Description
Participants will have their HVAC system modified to include high efficiency filtration. They will begin sham filtration.
Intervention Type
Other
Intervention Name(s)
Stand Alone Air Cleaner
Intervention Description
This is an environmental intervention using a stand alone air cleaner designed to reduce the air pollution levels in the home.
Intervention Type
Other
Intervention Name(s)
HVAC Modification
Intervention Description
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 Outcome Measure Information:
Title
Days with asthma symptoms
Description
The maximum number of days with symptoms, from a two-week recall period, will be determined every three months. The maximum number of days with symptoms will be defined as the largest value among the following three variables: (i) number of days with wheezing, tightness in the chest, or cough because of asthma, (ii) number of days that the child had to slow down or stop his/her play or activities because of asthma, wheezing or tightness in the chest, or cough, or (iii) number of nights that the child woke up because of asthma, wheezing or tightness in the chest, or cough. The seasonally adjusted mean difference in the number of symptom days between the true and sham filtration periods will be estimated using generalized linear mixed-effects regression models.
Time Frame
Measured at 3, 6, 9, 12, 15, 18, 21, and 24 months
Secondary Outcome Measure Information:
Title
Forced expiratory volume at one second, percent predicted (FEV1 % predicted)
Description
Lung function will be assessed using FEV1 % predicted. The adjusted mean difference in the FEV1% predicted between the true and sham filtration periods will be estimated using generalized linear mixed-effects regression models.
Time Frame
Measured at 12 months and 24 months
Title
Forced vital capacity, percent predicted (FVC % predicted)
Description
Lung function will be assessed using FVC % predicted. The adjusted mean difference in the FVC% predicted between the true and sham filtration periods will be estimated using generalized linear mixed-effects regression models.
Time Frame
Measured at 12 months and 24 months
Title
Peak Expiratory Flow Rate (PEFR)
Description
Lung function will be assessed using morning peak expiratory flow rate (PEFR), averaged for all days over one-week testing periods. The seasonally adjusted mean difference in the PERF measure between the true and sham filtration periods will be estimated using generalized linear mixed-effects regression models.
Time Frame
Measured at 3, 6, 9, 12, 15, 18, 21, and 24 months
Title
Exhaled NO
Description
The seasonally adjusted mean difference in the Exhaled NO between the true and sham filtration periods will be estimated using generalized linear mixed-effects regression models.
Time Frame
Measure at 6, 12, 18, and 24 months
Title
Days of missing school due to asthma
Description
Days of missing school due to asthma will be expressed as a proportion of days of missing school versus the total number of school days during a two-week period. The seasonally adjusted mean difference in the proportion of missed school days between the true and sham filtration periods will be estimated using generalized linear mixed-effects regression models.
Time Frame
Measured at 3, 6, 9, 12, 15, 18, 21, and 24 months
Title
Days of missing work for parents due to child's asthma
Description
Days of missing work due to child's asthma will be expressed as a proportion of days of missing work versus the total number of work days during a two-week period. The seasonally adjusted mean difference in the proportion of missed work days between the true and sham filtration periods will be estimated using generalized linear mixed-effects regression models.
Time Frame
Measured at 3, 6, 9, 12, 15, 18, 21, and 24 months
Title
Hospitalizations
Description
The number of overnight hospitalizations due to asthma will be assessed every 3 months during real and sham periods. Participants will report number of overnight hospitalizations due to asthma that occurred in the previous three months. The adjusted mean hospitalization incidence ratio between the true and sham filtration periods will be compared using mixed-effects Poison regression models.
Time Frame
Count during 1-year true filtration period and count during 1-year sham filtration period
Title
Emergency Room Visits
Description
The number of emergency room visits due to asthma will be assessed every 3 months during real and sham periods. Participants will report number of emergency room visits due to asthma that occurred in the previous three months. The adjusted mean emergency room visit incidence ratio between the true and sham filtration periods will be compared using generalized mixed-effects regression models.
Time Frame
Count during 1-year true filtration period and count during 1-year sham filtration period
Title
Unplanned Clinic Visits
Description
The number of unplanned clinic visits due to asthma will be assessed every 3 months during real and sham periods. Participants will report number of unplanned clinic visits due to asthma that occurred in the previous three months. The adjusted mean unplanned clinic visit incidence ratio between the true and sham filtration periods will be compared using generalized mixed-effects regression models.
Time Frame
Count during 1-year true filtration period and count during 1-year sham filtration period
Title
Unplanned Steroid treatments
Description
The number of unplanned steroid treatments due to asthma will be assessed every 3 months during real and sham periods. Participants will report number of unplanned steroid treatments due to asthma that occurred in the previous three months. The adjusted mean unplanned steroid treatment incidence ratio between the true and sham filtration periods will be compared using generalized mixed-effects regression models.
Time Frame
Count during 1-year true filtration period and count during 1-year sham filtration period
Title
Mini Pediatric Asthma Quality of Life Questionnaire (MiniPAQLQ)
Description
The MiniPAQLQ has three composite domains, symptoms, emotional function, and activity limitation, each of which will be analyzed separately. The seasonally adjusted mean difference in each domain score between the true and sham filtration periods will be estimated using generalized linear mixed-effects regression models.
Time Frame
Measured at 3, 6, 9, 12, 15, 18, 21, and 24 months
Title
Allergy symptoms
Description
Allergy symptoms during two week recall periods will be summarized into a composite score. The seasonally adjusted mean difference in the scores between the true and sham filtration periods will be using generalized linear mixed-effects regression models.
Time Frame
Measured at 3, 6, 9, 12, 15, 18, 21, and 24 months
Title
Respiratory disease
Description
The number of incidents of respiratory disease will be assessed every 3 months during real and sham periods. Participants will report number of incidents of respiratory disease that occurred in the previous three months. The adjusted mean respiratory disease incidence ratio between the true and sham filtration periods will be compared using generalized mixed-effects regression models.
Time Frame
Count of incidents of respiratory disease during 1-year true filtration period and count during 1-year sham filtration period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deborah Bennett, PhD
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Davis- Department of Public Health Sciences
City
Davis
State/Province
California
ZIP/Postal Code
95616
Country
United States

12. IPD Sharing Statement

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Asthma and Indoor-air: Reducing Exposures

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