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

NCT03705325 | Completed FDA Device

• 1 other identifier: VF-Cor2018
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Asthma; Asthma Attack; Asthma, Allergic

Outcome Measures

Primary Outcomes (1)

• change in FEV1 from baseline during "yellow zone" events

  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 Outcomes (1)

• Correlation between change in FEV1 from baseline during yellow zone events and likelihood of experiencing unscheduled healthcare visits

  6 months

Study Arms (1)

Spirobank smart spirometer with VitalFlo mobile app

EXPERIMENTAL

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

Interventions

Spirobank Smart spirometer DEVICE

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.

Spirobank smart spirometer with VitalFlo mobile app

Eligibility Criteria

• Age: 12 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• VitalFlo Inc.: lead
• University of North Carolina, Chapel Hill: collaborator

Study Sites (2)

EPA Human Studies Facility

Chapel Hill, North Carolina, 27599-7310, United States

Location

NC State Park Scholars Children's Specialty Clinic

Raleigh, North Carolina, 27607, United States

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Allison Burbank, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 10, 2018
• First Posted: October 15, 2018
• Study Start: February 22, 2019
• Primary Completion: August 3, 2020
• Study Completion: August 3, 2020
• Last Updated: October 6, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)