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

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ClinicalTrials.gov Identifier: NCT03705325
Recruitment Status : Recruiting
First Posted : October 15, 2018
Last Update Posted : October 19, 2018
Sponsor:
Collaborator:
University of North Carolina, Chapel Hill
Information provided by (Responsible Party):
VitalFlo Inc.

Brief Summary:
The investigators will study the use of a home-based spirometer (VitalFlo) that connects to a smartphone app 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.

Condition or disease Intervention/treatment Phase
Asthma Asthma Attack Asthma, Allergic Device: VitalFlo spirometer Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 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 VitalFlo spirometer for home use and an iPhone 5S (without SIM card) loaded with the VitalFlo app. Participants will be asked to use the VitalFlo 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)
Primary Purpose: Other
Official Title: Evaluating Asthma Exacerbation-induced Changes in Lung Function With a Home-based Spirometer
Estimated Study Start Date : October 2018
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: VitalFlo spirometer
In this single arm study, all participants will be receive the VitalFlo spirometer and an iPhone 5S (without SIM card) loaded with the VitalFlo app.
Device: VitalFlo spirometer
The VitalFlo 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.




Primary Outcome Measures :
  1. 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 VitalFlo 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.


Secondary Outcome Measures :
  1. 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

  2. Correlation between FEV1 measurements from VitalFlo spirometer and commercially available handheld spirometer for use in clinical care [ Time Frame: 18 months ]
    • To assess the agreement between the VitalFlo device and the commercially available handheld spirometer used at the study visits, with the latter taken as the 'gold standard'



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Ages Eligible for Study:   12 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT03705325


Contacts
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Contact: Sally Ivins 919-966-7157 sivins@email.unc.edu
Contact: Carole Robinette 919-966-5368 carole_robinette@med.unc.edu

Locations
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United States, North Carolina
EPA Human Studies Facility Recruiting
Chapel Hill, North Carolina, United States, 27599-7310
Contact: Sally Ivins    919-966-7157    sivins@email.unc.edu   
Contact: Carole Robinette, M    919-966-5638    carole_robinette@med.unc.edu   
NC State Park Scholars Children's Specialty Clinic Recruiting
Raleigh, North Carolina, United States, 27607
Contact: Sally Ivins    919-966-7157    sivins@email.unc.edu   
Sponsors and Collaborators
VitalFlo Inc.
University of North Carolina, Chapel Hill
Investigators
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Principal Investigator: Allison Burbank, MD University of North Carolina, Chapel Hill

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Responsible Party: VitalFlo Inc.
ClinicalTrials.gov Identifier: NCT03705325     History of Changes
Other Study ID Numbers: VF-Cor2018
First Posted: October 15, 2018    Key Record Dates
Last Update Posted: October 19, 2018
Last Verified: October 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: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

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