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

Completed · Not applicable

Conditions studied: Asthma, Asthma Attack, Asthma, Allergic

In brief

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.

Key facts

Study ID

NCT03705325

Run by

VitalFlo Inc.

People needed

44

Starts

2019-02-22

Expected to finish

2020-08-03

Last updated by the study team

2020-10-06

Who can join

Age: 12 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

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

Full record on ClinicalTrials.gov

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