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

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ClinicalTrials.gov Identifier: NCT03642418
Recruitment Status : Recruiting
First Posted : August 22, 2018
Last Update Posted : August 22, 2018
Sponsor:
Information provided by (Responsible Party):
Ngoc Ly, MD, MPH, University of California, San Francisco

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.

Condition or disease
Asthma Acute Asthma in Children Asthma Chronic Asthma Attack

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


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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: User-Friendly Spirometer and Mobile App for Self-Management and Home Monitoring of Asthma Patients Phase 2
Actual Study Start Date : August 13, 2018
Estimated Primary Completion Date : August 31, 2019
Estimated Study Completion Date : January 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma




Primary Outcome Measures :
  1. Yellow Zone episodes [ Time Frame: 44 weeks ]
    defined by the occurrence of any of the following: (1) Symptom Diary score > 4 and (2) ATAQ score > 1


Secondary Outcome Measures :
  1. Red Zone episodes [ Time Frame: 44 weeks ]

    defined by the occurrence of any of the following:

    ED or Urgent Care visit Administration of systemic (oral, IM, or IV) corticosteroids Hospitalization




Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children 6 to15 years old with mild to moderate persistent asthma seen in the outpatient clinic
Criteria

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™)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03642418


Contacts
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Contact: Courtney Moreno 415-476-2984 Courtney.Moreno@ucsf.edu

Locations
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United States, California
UCSF- Benioff Children Hospital Recruiting
San Francisco, California, United States, 94158
Contact: Courtney Moreno    415-476-2984    Courtney.Moreno@ucsf.edu   
Contact: Joseph Dang    415-531-8668    Joseph.Dang@ucsf.edu   
Principal Investigator: Ngoc P Ly, MD         
Principal Investigator: Kensho Iwanaga, MD         
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Ngoc P Ly, MD University of California, San Francisco

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Responsible Party: Ngoc Ly, MD, MPH, Professor of Pediatrics, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03642418     History of Changes
Other Study ID Numbers: 17-22946
First Posted: August 22, 2018    Key Record Dates
Last Update Posted: August 22, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ngoc Ly, MD, MPH, University of California, San Francisco:
asthma, children, spirometry, lung function, asthma action plan, asthma exacerbation, self management

Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases