User-Friendly Spirometer and Mobile App for Self-Management and Home Monitoring of Asthma Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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User-Friendly Spirometer and Mobile App for Self-Management and Home Monitoring of Asthma Patients Phase 2

Conditions
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Asthma Acute, Asthma in Children, Asthma Chronic, Asthma Attack

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Physician-diagnosed mild or moderate persistent asthma On controller therapy [inhaled corticosteroid (ICS), ICS + leukotriene receptor antagonist (LTRA), or ICS + long-acting beta agonist (LABA)] for at least the previous six months At least one severe exacerbation requiring systemic corticosteroids in the previous year Baseline FEV1 >/= 70% predicted for age, gender, and height according to published reference standards Parental consent and the child's assent 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: 3 hospitalizations 6 severe exacerbations in the previous year on chronic oral corticosteroid therapy daily symptoms 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-Fi™)

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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asthma, children, spirometry, lung function, asthma action plan, asthma exacerbation, self management