Asthma AcuteNCT03642418
User-Friendly Spirometer and Mobile App for Self-Management and Home Monitoring of Asthma Patients
An observational study of Asthma Acute and Asthma in Children, run by University of California, San Francisco at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 6 to 15 years
- Conditions the study is for
- Asthma Acute, Asthma in Children, Asthma Chronic
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Aug 2018to 31 Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: Children 6 to15 years old with mild to moderate persistent asthma seen in the outpatient clinic
Who may be able to join
- 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
Who cannot join
- Chronic obstructive respiratory disorder other than asthma (e.g., cystic fibrosis, primary ciliary dyskinesia)
- 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
- Inability to perform acceptable spirometry
- History of collapsed lung
Show all 9Show fewer
- 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™)
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF- Benioff Children Hospital
San Francisco, California, 94158
About this study
Official title: 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.
Read the 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
- Conditions
- Asthma Acute, Asthma in Children, Asthma Chronic, Asthma Attack
- Keywords
- asthma, children, spirometry, lung function, asthma action plan, asthma exacerbation, self management
- Medical subject headings
- Asthma
What is being measured
The primary outcome is the main question the study is designed to answer.
Yellow Zone episodes
defined by the occurrence of any of the following: (1) Symptom Diary score > 4 and (2) ATAQ score > 1
Measured: 44 weeks
Secondary outcomes (1)
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
Measured: 44 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2018
- Study start13 Aug 2018
- Primary completion31 Dec 2019
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma AcuteStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ngoc P Ly, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03642418
- Sponsor's protocol ID
- 17-22946
- Status last verified
- Jul 2020
- First submitted
- 20 Aug 2018
- Last updated
- 15 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- User-Friendly Spirometer and Mobile App for Self-Management and Home Monitoring of Asthma Patients Phase 2
- ClinicalTrials.gov ID
- NCT03642418
- Acronym / sponsor ID
- 17-22946
- Conditions
- Asthma Acute, Asthma in Children, Asthma Chronic, Asthma Attack
- Keywords
- asthma, children, spirometry, lung function, asthma action plan, asthma exacerbation, self management
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 13 Aug 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 22 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children 6 to15 years old with mild to moderate persistent asthma seen in the outpatient clinic
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- Chronic obstructive respiratory disorder other than asthma (e.g., cystic fibrosis, primary ciliary dyskinesia)
- Severe persistent asthma, as evidenced by any of the following:
- Inability to perform acceptable spirometry
- History of collapsed lung
- History of syncope with forced exhalation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Red Zone episodes
Time frame: 44 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ngoc P Ly, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma Acute and Asthma in Children, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Yellow Zone episodes (time frame: 44 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2020.