Evaluating Efficacy of Smart Device in Assisting With Inhaler Technique and Adherence (MOMMIASTHMA1)

Landon Pediatric Foundation

Status and phase: Unknown; Early Phase 1

Conditions: Asthma; Adherence, Medication; Childhood Asthma

Treatments: Device: CapMedic smart inhaler device; Behavioral: Video-based guidance

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04250779

MOMMIASTHMA1

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 8+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups, including a placebo group

Control Group

Placebo Comparator group

Description:

In this arm, patients are provided with standard-of-care instructions on using MDIs correctly and regularly at home. The MDI usage is recorded using CapMedic device with active guidance turned off.

Treatment:

Behavioral: Video-based guidance

Treatment Group

Active Comparator group

Description:

In this arm, patients are provided with active guidance from CapMedic device on using MDIs correctly and regularly at home. The MDI usage is recorded using CapMedic device with active guidance turned on.

Treatment:

Device: CapMedic smart inhaler device