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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date July 2020
Source University of California, San Francisco
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

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.


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


Recruitment information / eligibility

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™)

Study Design


Locations

Country Name City State
United States UCSF- Benioff Children Hospital San Francisco California

Sponsors (1)

Lead Sponsor Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

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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