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

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.

Study Overview

• Status: Completed
• Conditions: Asthma in Children; Asthma Attack; Asthma Acute; Asthma Chronic

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 Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94158
      • UCSF- Benioff Children Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 15 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Children 6 to15 years old with mild to moderate persistent asthma seen in the outpatient clinic

Description

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™)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Investigators: Principal Investigator: Ngoc P Ly, MD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 13, 2018
• Primary Completion (ACTUAL): December 31, 2019
• Study Completion (ACTUAL): January 31, 2020

Study Registration Dates

• First Submitted: August 20, 2018
• First Submitted That Met QC Criteria: August 20, 2018
• First Posted (ACTUAL): August 22, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 15, 2020
• Last Update Submitted That Met QC Criteria: July 13, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: asthma, children, spirometry, lung function, asthma action plan, asthma exacerbation, self management
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: 17-22946

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No