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

NCT03642418 | Completed

• 1 other identifier: 17-22946
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma Acute; Asthma in Children; Asthma Chronic; Asthma Attack

Keywords

asthma, children, spirometry, lung function, asthma action plan, asthma exacerbation, self management

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Red Zone episodes

  44 weeks

Eligibility Criteria

• Age: 6 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Physician-diagnosed mild or moderate persistent asthma
• 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
• At least one severe exacerbation requiring systemic corticosteroids in the previous year
• Baseline FEV1 \>/= 70% predicted for age, gender, and height according to published reference standards
• Parental consent and the child's assent

You may not qualify if:

• Chronic obstructive respiratory disorder other than asthma (e.g., cystic fibrosis, primary ciliary dyskinesia)
• Severe persistent asthma, as evidenced by any of the following:
• hospitalizations
• severe exacerbations in the previous year on chronic oral corticosteroid therapy daily symptoms
• Inability to perform acceptable spirometry
• History of collapsed lung
• History of syncope with forced exhalation
• Not owning an iOS™ device (e.g., iPhone®, iPod®, or iPad®)
• Lacking access to wireless local area networking (Wi-Fi™)

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

UCSF- Benioff Children Hospital

San Francisco, California, 94158, United States

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Ngoc P Ly, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2018
• First Posted: August 22, 2018
• Study Start: August 13, 2018
• Primary Completion: December 31, 2019
• Study Completion: January 31, 2020
• Last Updated: July 15, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)