NCT03642418

Completed

User-Friendly Spirometer and Mobile App for Self-Management ...

University of California, San Francisco Source

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Other study identifiers

Sponsor study identifier

17-22946

Study Type

observational

Actual enrollment (reported)

20

Locations

1 country

Sites

1

Timeline

Study Start

August 13, 2018

Actual (reported)

Primary Completion

December 31, 2019

Actual (reported)

Study Completion

January 31, 2020

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 20 participants
Study completion date: January 31, 2020
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
August 13, 2018
Actual (reported)
First Submitted
August 20, 2018
Actual (reported)
First Posted
August 22, 2018
Actual (reported)
Primary Completion
December 31, 2019
Actual (reported)
Study Completion
January 31, 2020
Actual (reported)

Last Updated: July 15, 2020
Status Verified: July 2020
Last Update Submitted: July 13, 2020

Conditions

Asthma Acute Asthma Attack Asthma Chronic Asthma in Children

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

Age6 Years - 15 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

Sampling MethodNon-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

Sponsors & Collaborators

University of California, San Francisco
Otherlead

Study Sites (1)

UCSF- Benioff Children Hospital

San Francisco, California, 94158, United States

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

Ngoc P Ly, MD
University of California, San Francisco
PRINCIPAL INVESTIGATOR

Enrollment

20 participants (actual enrollment reported by the registry).

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

Actual (reported)

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Completed

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™)

Contact the study team to confirm eligibility.

Primary Completion

December 31, 2019

Actual (reported)

Study Completion

January 31, 2020

Actual (reported)

Last Updated

July 15, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing: Will not share

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT03642418
Data provider: ClinicalTrials.gov
Source updated: 2020-07-15
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:35:57 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations