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

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

• 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™)