Evaluating Asthma Exacerbation-induced Changes in Lung Function With a Home-based Spirometer
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|ClinicalTrials.gov Identifier: NCT03705325|
Recruitment Status : Completed
First Posted : October 15, 2018
Last Update Posted : October 6, 2020
|Condition or disease||Intervention/treatment||Phase|
|Asthma Asthma Attack Asthma, Allergic||Device: Spirobank Smart spirometer||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||44 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||This is a prospective single arm study of 12-21 year olds with persistent asthma. Participants will be given the home spirometer and 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. After performing the spirometry maneuver, the user will be prompted to answer questions about their asthma symptoms. Changes in lung function will be matched to subject-reported asthma symptoms and/or albuterol use.|
|Masking:||None (Open Label)|
|Official Title:||Evaluating Asthma Exacerbation-induced Changes in Lung Function With a Home-based Spirometer|
|Actual Study Start Date :||February 22, 2019|
|Actual Primary Completion Date :||August 3, 2020|
|Actual Study Completion Date :||August 3, 2020|
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.
- 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.
- 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
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): NCT03705325
|United States, North Carolina|
|EPA Human Studies Facility|
|Chapel Hill, North Carolina, United States, 27599-7310|
|NC State Park Scholars Children's Specialty Clinic|
|Raleigh, North Carolina, United States, 27607|
|Principal Investigator:||Allison Burbank, MD||University of North Carolina, Chapel Hill|