Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2025-12-25 @ 5:05 AM
NCT ID:
NCT03642418
Brief Summary:
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:
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
Study:
NCT03642418
Study Brief:
Protocol Section:
NCT03642418