Evaluating Asthma Exacerbation-induced Changes in Lung Function With a Home-based Spirometer

October 5, 2020 updated by: VitalFlo Inc.
The investigators will study the use of a home-based spirometer (Spirobank Smart spirometer) that connects to a smartphone app (VitalFlo) in teenagers with persistent asthma to determine if clinically significant changes in lung function detected by the spirometer are associated with patient-reported asthma symptoms.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Asthma is a common chronic illness and significant expense to our healthcare system. Asthma affects nearly 25 million Americans, including 10% of U.S. adolescents. Teenagers are one of the most difficult groups to engage in self-management of chronic health problems like asthma and are at greater risk of poorly controlled asthma compared to younger children. Up to 80% of children with asthma are non-adherent to their controller medications, often due to lack of parent or child-perceived need or beneficial effects of these medications. Adolescents may have a higher threshold for initiating rescue treatment due to the perceived normalcy of asthma symptoms and frequently under-report symptoms to parents and healthcare providers.

Poor perception of asthma symptoms leads to overestimation of asthma control. Defining well controlled versus poorly controlled asthma is highly dependent on self-reported asthma symptoms. Up to half of patients with severe asthma symptoms report well controlled asthma. Many have low expectations of asthma control and have adapted to the disease so much so that they no longer perceive their limitations. Inaccurate self-reported data can be problematic in studies evaluating the impact of environmental factors or the efficacy of asthma treatments. An objective measure of asthma impairment is pulmonary function testing performed by spirometry. Ready access to a conventional spirometer is not always realistic in clinical care or research settings. The investigators propose integrating technology-based tools that leverage on the high rates of smartphone use among youth to identify early signs of deteriorating asthma control.

The Spirobank smart spirometer is a compact, portable, home-based spirometer approximately the size of an inhaler that pairs with a smartphone app called VitalFlo. The device uses an energy conserving turbine. Exhaled air flow causes the turbine to rotate, generating a voltage analogous to the rate of air flow across the turbine. The spirometer measures Forced expiratory volume in 1 second (FEV1), or the volume of air that is exhaled in the first second. The device prompts the user to perform a minimum of three expiratory maneuvers in and records the best of the three maneuvers. The information generated is collected on a microprocessor and then transmitted by a low power Bluetooth radio to the VitalFlo App (password protected) on the user's iPhone. The user is alerted, by the App, if their expiratory effort is inadequate (such as early termination of exhalation) and is provided coaching for proper technique. The data is then transmitted to a HIPAA-compliant cloud database. Participants will receive a survey after each time they measure lung function to gather information about any asthma symptoms they are experiencing. Investigators will ask that they use the spirometer prior to using albuterol for symptoms if possible. VitalFlo will also track, via cloud databases, outdoor temperature, humidity, air quality, and pollen counts: all environmental factors that can influence asthma symptoms. Routine calibration is not needed. The eventual goal of home spirometer use is to identify drops in lung function preceding asthma symptoms to allow persons with asthma to intervene with rescue medications early in hopes of preventing progression to a more serious exacerbation of asthma ("red zone") requiring healthcare utilization, such as emergency care or hospitalization.

This is a prospective single arm intervention study of 12-21 year olds with persistent asthma. Participants will be given the home spirometer after receiving instruction on proper use of the device. The participants will also receive an iPhone 5S (without SIM card) loaded with the VitalFlo app. Participants will be asked to use the spirometer at least twice daily (in the morning between 6am and 10am and in the evening between 6am and 10pm) and whenever rescue medication (albuterol) is administered or the participant feels symptoms of asthma (such as cough, wheezing, or shortness of breath) in order to document lung function. Pulmonary function testing is known to show diurnal variability. Investigators will use the morning and evening measurements to calculate the mean FEV1 for the day. After performing the spirometry maneuver, the user will be prompted to answer questions about their asthma symptoms. The lung function measurements and responses to the questions will be transmitted to a cloud-based HIPAA-compliant database and will be available for the investigators to download. Changes in lung function will be matched to subject-reported asthma symptoms and/or albuterol use.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
44

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599-7310
        • EPA Human Studies Facility
      • Raleigh, North Carolina, United States, 27607
        • NC State Park Scholars Children's Specialty Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

8 years to 17 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Ages 12 to 21 years, inclusive, of both genders
  2. Physician diagnosis of persistent asthma or symptoms consistent with persistent asthma based on NHLBI Expert Panel Review 3 guidelines for diagnosis and management of asthma.
  3. Current use of a controller therapy such as an inhaled corticosteroid (ICS), ICS in combination with long-acting beta agonist (LABA), or leukotriene receptor antagonist (LTRA).
  4. A history of at least one asthma exacerbation requiring oral corticosteroids (OCS) in the past 12 months.
  5. Wireless internet access in the participant's home

Exclusion Criteria:

  1. Systemic corticosteroid-dependent asthma (i.e. people who take oral steroids such as prednisone daily for asthma control).
  2. Pulmonary disease other than asthma that in the opinion of investigators may affect the interpretation of spirometry data, including but not limited to vocal cord dysfunction, restrictive lung disease, or cystic fibrosis.
  3. Inability to perform spirometry.
  4. History of spirometry-induced bronchoconstriction.
  5. Pregnancy or nursing a baby.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Spirobank smart spirometer with VitalFlo mobile app
In this single arm study, all participants will be receive the spirometer and an iPhone 5S (without SIM card) loaded with the VitalFlo app.
Device: Spirobank Smart spirometer
The spirometer is a compact, portable, home-based spirometer that pairs with a smartphone app. Exhaled air flow causes the turbine to rotate, generating a voltage analogous to the rate of air flow across the turbine. The spirometer measures Forced expiratory volume in 1 second (FEV1), or the volume of air that is exhaled in the first second. The device prompts the user to perform a minimum of three expiratory maneuvers in and records the best of the three maneuvers. The information generated is then transmitted to the VitalFlo App (password protected) on the user's iPhone. The user is alerted, by the App, if their expiratory effort is inadequate (such as early termination of exhalation) and is provided coaching for proper technique.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
change in FEV1 from baseline during "yellow zone" events
Time Frame: 6 months
To determine if there is a clinically significant reduction from baseline in FEV1 percent predicted (for age, sex, height, and race) values obtained from the spirometer associated with "yellow zone" events, as defined by the participant's personalized asthma action plan. For the purposes of this study, we will define yellow zone events as any asthma symptoms (such as cough, wheezing, chest tightness) with or without use of rescue albuterol (excluding pre-exercise use of albuterol). A reduction of 10 percentage points or more in mean percent predicted FEV1 will be considered a clinically significant change.
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Correlation between change in FEV1 from baseline during yellow zone events and likelihood of experiencing unscheduled healthcare visits
Time Frame: 6 months
To determine if the magnitude of the change from baseline in FEV1 associated with yellow zone events predicts unscheduled healthcare visits with the participant's primary care physician. Participants will be queried at each study visit about doctor's visits, emergency or urgent care visits, or hospitalizations related to asthma and whether or not oral steroids were prescribed
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
VitalFlo Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of North Carolina, Chapel Hill

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Allison Burbank, MD, University of North Carolina, Chapel Hill

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 22, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 3, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 3, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 10, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 10, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 15, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 6, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 5, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • VF-Cor2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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Drug Interventions

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