Asthma Clinical Trial
— MOMMIASTHMA1Official title:
Evaluating Efficacy of Smart Device in Assisting With Inhaler Technique and Adherence
Asthma affects over 10 million children in the U.S., and poses a significant health and cost
burden. Metered dose inhaler (MDI) is the most common method of treatment. Studies show that
up to 80% of patients demonstrate incorrect use of MDIs, which results in suboptimal
medication delivery to the lungs.
Asthma control can be followed by symptoms, rescue medication usage and measures of airflow
obstruction. Current options to monitor control include an asthma diary (relies on consistent
use by the patient), pharmacy records of medication dispensing (dispensing does not equal
usage), and peak expiratory flow (PEF) meters (significant variability in technique leading
to inconsistent results).
CapMedic is a smart inhaler and home spirometer device which aims to assist with correct MDI
usage and to monitor asthma control. CapMedic fits on top of the MDI inhaler and provides
live audio-visual-haptic cues to guide the patient for correctly using their inhaler.
CapMedic includes a built-in forced expiratory flow in 1 second (FEV1, a measure of airflow)
and PEF meter. It will utilize the same audio-visual-haptic hardware to implement live cues
that encourage patient's effort in performing accurate at-home FEV1/PEF test. Cap will also
be able to log medication usage and Medic application will allow patients to keep an asthma
symptom diary.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | December 1, 2021 |
Est. primary completion date | July 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 8 Years and older |
Eligibility |
Inclusion Criteria: - Diagnosis of Asthma - Regular user of MDI - Asthma Control Test (ACT) scores between 15 and 25 - FEV1 between 60-80% of predicted (persistent mild-moderate) - Disease severity in the range mild-moderate - Access to a Smartphone and internet during the entire duration of the study. - Cognitively able to utilize the device and express interest in participating. Exclusion Criteria: - Patients without asthma - With developmental disabilities - Do not speak English - Do not own a Smartphone |
Country | Name | City | State |
---|---|---|---|
United States | Pediatric Diagnostic Center | Ventura | California |
Lead Sponsor | Collaborator |
---|---|
Landon Pediatric Foundation | Cognita Labs LLC |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | MDI use Competence in Clinic | Correctness of Inhaler Use measured using CapMedic device during recruitment. Competence is measured as a score out of 4 for 4 steps of MDI use: 1. Shaking, 2. Orientation, 3. Coordination 4. Duration of inhalation | 1 day | |
Primary | MDI use Competence at home | Correctness of Inhaler Use measured using CapMedic device at home. Competence is measured as a score out of 4 for 4 steps of MDI use: 1. Shaking, 2. Orientation, 3. Coordination 4. Duration of inhalation | 8 weeks | |
Secondary | PEF Lung Function in Clinic | PEF measured using CapMedic device during recruitment. PEF is measured in L/min. | 1 day | |
Secondary | FEV1 Lung Function in Clinic | FEV1 measured using CapMedic device during recruitment. FEV1 is measured in L. | 1 day | |
Secondary | PEF Lung Function at home | PEF measured using CapMedic device at home. PEF is measured in L/min. | 8 weeks | |
Secondary | FEV1 Lung Function at home | FEV1 measured using CapMedic device at home. FEV1 is measured in L. | 8 weeks | |
Secondary | MDI use Adherence | Regularity of MDI use measured by CapMedic device at home, measured as a % of puffs taken per week compared to prescribed dosage. | 8 weeks |
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