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The primary goal of this proposal is to use an in-home, smartphone-enabled, hand-held spirometer to determine the FEV1% predicted ranges that predict the Yellow Zone threshold.
The study hypothesizes that objective lung function tracking at-home, using a portable spirometer in addition to conventional symptom monitoring (in which asthmatic patients self-report and track their own symptoms), will result in more reliable detection of exacerbation in children 6-15 years old with asthma.
This is a 44-week, single arm, blinded nonrandomized trial to determine clinically relevant ranges in FEV1% predicted that correlate with the Yellow Zone of the Asthma Action Plan.
A total of 100 pediatric subjects (between the ages of 6 and 15 years old) with physician-diagnosed mild or moderate persistent asthma treated on controller therapy will be enrolled from the ED, Inpatient Units, Pulmonary Medicine Clinic, and Allergy/Immunology Clinic at UCSF Benioff Children's Hospital San Francisco.
Primary Specific Aim
To determine the FEV1% predicted changes that correspond with a change from the Green to Yellow Zone.
The primary outcome will be Yellow Zone episodes, as identified by the occurence of any of the following:
Symptom Diary score > 4 ATAQ score > 1
Secondary Specific Aim
To determine the FEV1% predicted changes that correspond with a change from the Yellow to Red Zone.
The secondary outcome will Red Zone episodes, as identified by the occurence of any of the following:
ED or Urgent Care visit Administration of systemic (oral, IM, or IV) corticosteroids Hospitalization
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| Measure | Description | Time Frame |
|---|---|---|
| Yellow Zone episodes | defined by the occurrence of any of the following: (1) Symptom Diary score > 4 and (2) ATAQ score > 1 | 44 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Red Zone episodes | defined by the occurrence of any of the following: ED or Urgent Care visit Administration of systemic (oral, IM, or IV) corticosteroids Hospitalization | 44 weeks |
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Inclusion Criteria:
Exclusion Criteria:
Chronic obstructive respiratory disorder other than asthma (e.g., cystic fibrosis, primary ciliary dyskinesia)
Severe persistent asthma, as evidenced by any of the following:
Inability to perform acceptable spirometry
History of collapsed lung
History of syncope with forced exhalation
Not owning an iOS™ device (e.g., iPhone®, iPod®, or iPad®)
Lacking access to wireless local area networking (Wi-Fiâ„¢)
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Children 6 to15 years old with mild to moderate persistent asthma seen in the outpatient clinic
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| Name | Affiliation | Role |
|---|---|---|
| Ngoc P Ly, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSF- Benioff Children Hospital | San Francisco | California | 94158 | United States |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |