Evaluating Asthma Exacerbation-induced Changes in Lung Function With a Home-based Spirometer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03705325|
Recruitment Status : Completed
First Posted : October 15, 2018
Last Update Posted : October 6, 2020
- Study Details
- Tabular View
- Results Submitted
- How to Read a Study Record
|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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||12 Years to 21 Years (Child, Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Ages 12 to 21 years, inclusive, of both genders
- 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.
- 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).
- A history of at least one asthma exacerbation requiring oral corticosteroids (OCS) in the past 12 months.
- Wireless internet access in the participant's home
- Systemic corticosteroid-dependent asthma (i.e. people who take oral steroids such as prednisone daily for asthma control).
- 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.
- Inability to perform spirometry.
- History of spirometry-induced bronchoconstriction.
- Pregnancy or nursing a baby.
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|
|Responsible Party:||VitalFlo Inc.|
|Other Study ID Numbers:||
|First Posted:||October 15, 2018 Key Record Dates|
|Last Update Posted:||October 6, 2020|
|Last Verified:||October 2020|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||Yes|
|Device Product Not Approved or Cleared by U.S. FDA:||Yes|
|Product Manufactured in and Exported from the U.S.:||Yes|
Respiratory Tract Diseases
Lung Diseases, Obstructive
Immune System Diseases