Asthma Clinical Trial
Official title:
Evaluating Asthma Exacerbation-induced Changes in Lung Function With a Home-based Spirometer
Verified date | October 2020 |
Source | VitalFlo Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 44 |
Est. completion date | August 3, 2020 |
Est. primary completion date | August 3, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years to 21 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | EPA Human Studies Facility | Chapel Hill | North Carolina |
United States | NC State Park Scholars Children's Specialty Clinic | Raleigh | North Carolina |
Lead Sponsor | Collaborator |
---|---|
VitalFlo Inc. | University of North Carolina, Chapel Hill |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Correlation between change in FEV1 from baseline during yellow zone events and likelihood of experiencing unscheduled healthcare visits | 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 | 6 months |
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