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

 1. Physician-diagnosed mild or moderate persistent asthma

 2. 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

 3. At least one severe exacerbation requiring systemic corticosteroids in the previous
 year

 4. Baseline FEV1 >/= 70% predicted for age, gender, and height according to published
 reference standards

 5. Parental consent and the child's assent

 Exclusion Criteria:

 1. Chronic obstructive respiratory disorder other than asthma (e.g., cystic fibrosis,
 primary ciliary dyskinesia)

 2. 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

 3. Inability to perform acceptable spirometry

 4. History of collapsed lung

 5. History of syncope with forced exhalation

 6. Not owning an iOS™ device (e.g., iPhone®, iPod®, or iPad®)

 7. Lacking access to wireless local area networking (Wi-Fi™)