Asthma in Children Clinical Trial
Official title:
User-Friendly Spirometer and Mobile App for Self-Management and Home Monitoring of Asthma Patients Phase 2
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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