Asthma in Children Clinical Trial
Official title:
User-Friendly Spirometer and Mobile App for Self-Management and Home Monitoring of Asthma Patients Phase 2
NCT number | NCT03642418 |
Other study ID # | 17-22946 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | August 13, 2018 |
Est. completion date | January 31, 2020 |
Verified date | July 2020 |
Source | University of California, San Francisco |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | January 31, 2020 |
Est. primary completion date | December 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Years to 15 Years |
Eligibility |
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™) |
Country | Name | City | State |
---|---|---|---|
United States | UCSF- Benioff Children Hospital | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Francisco |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 |
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