Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT03642418
Study type Observational
Source University of California, San Francisco
Contact
Status Completed
Phase
Start date August 13, 2018
Completion date January 31, 2020

See also
  Status Clinical Trial Phase
Completed NCT04450108 - Vivatmo Pro™ for Fractional Exhaled Nitric Oxide (FeNO) Monitoring in U.S. Asthmatic Patients N/A
Recruiting NCT05734261 - Forced Oscillations Technique During a Metacholine Test in Children N/A
Recruiting NCT06044051 - Dynamics of the Upper and Lower Airway Respiratory Microbiomes Associated With Severe Infant Asthma N/A
Completed NCT04896502 - Effectiveness of Telemedicine Home Assessments for Identification and Reduction of Asthma Triggers N/A
Completed NCT03503812 - Mitigating the Health Effects of Desert Dust Storms Using Exposure-Reduction Approaches N/A
Recruiting NCT06003569 - Reducing Asthma Attacks in Disadvantaged School Children With Asthma N/A
Not yet recruiting NCT05902702 - Isotonic Saline for Children With Bronchiolitis N/A
Not yet recruiting NCT05547477 - Continuous EMG Measurements in Children With Asthma During Sleep
Completed NCT04388098 - Oral Health Status of Asthmatic Children
Terminated NCT03586544 - Reducing Exercise-induced Bronchoconstriction in Children With Asthma and Obesity Phase 4
Recruiting NCT04821908 - Consequences of COVID 19 Pandemic on Childhood Asthma
Not yet recruiting NCT03277170 - Pragmatic RCT of High-dose Oral Montelukast for Moderate and Severe Pediatric Acute Asthma Exacerbations Phase 2
Enrolling by invitation NCT06239844 - Navigating Together for Equitable Asthma Management for Children in Families Who Communicate in Language Other Than English N/A
Not yet recruiting NCT05974917 - Serious gaMes as Emerging E-health Interventions for Young People With neurologicaL or rEspiratory disoRders
Not yet recruiting NCT05997784 - Study of Indoor Air Pollutants and Their Impact in Childhood Health and Wellbeing
Recruiting NCT05366309 - Performance and Adherence in Children Using Spacers N/A
Completed NCT05684926 - COVID-19 Pandemic Asthma Child Telerehabilitation Yoga N/A
Recruiting NCT04166344 - A mHealth Intervention to Improve Symptom Control in Children and Adolescents With Difficult-to-control Asthma N/A
Completed NCT05576142 - Oral Findings in Pediatric Patients With Allergic Rhinitis and/or Asthma
Completed NCT03907410 - The Tailored Adherence Incentives for Childhood Asthma Medications (TAICAM) Trial N/A