Recruiting
Early Phase 1

Smart Device

Sponsor:

Landon Pediatric Foundation

Code:

NCT04250779

Conditions

Asthma

Adherence, Medication

Childhood Asthma

Eligibility Criteria

Sex: All

Age: 8+

Healthy Volunteers: Not accepted

Interventions

CapMedic smart inhaler device

Video-based guidance

Study Details

Brief summary:

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.

Conditions

Asthma

Adherence, Medication

Childhood Asthma

Study ID

NCT04250779

Start date

Jul 1, 2019

Status verified date

Jan, 2020

Completion date

Dec 1, 2021

Anticipated

Primary completion date

Jul 1, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

placebo comparator: Control Group

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.

active comparator: Treatment Group

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.

Interventions

CapMedic smart inhaler device

The CapMedic device provides active coaching to promote correct and regular use of MDI.

Video-based guidance

Patients are shown a video of how to use inhalers correctly and any questions are answered by the clinician. They are also encouraged to use inhalers regularly and correctly at home.

Primary outcome measure

  • MDI use Competence in Clinic [ Time Frame: 1 day ]
  • MDI use Competence at home [ Time Frame: 8 weeks ]

Central Contacts and Locations

Central contacts

Locations

Pediatric Diagnostic Center

Recruiting

Ventura, California, United States, 93003

Contacts

Principal Investigator:

Chris Landon, MD

More Information

Sponsor

Landon Pediatric Foundation

Last update posted

Sep 16, 2020

Last verified

Jan, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Landon Pediatric Foundation on 2020-09-16.