At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Utilizing Advances in Digital Inhaler Technology to Understand Heterogeneous Treatment Responses to Biologics in Severe Asthma
In Brief
A Phase 4 clinical trial evaluating AirDuo Digihaler and ProAir Digihaler for Asthma. Completed, enrolled 100 participants across 1 site.
Detailed Summary
This trial is being completed to determine baseline inhalation parameters and patterns of use in patients receiving treatment with TEVA digital inhalers, to develop predictive models for asthma exacerbations and response to biologics using data collected from these devices. Enrolled participants will complete questionnaires along with other study specific procedures. Additionally, in-person and phone visits will be performed.
Study Details
Timeline
Interventions
Participants will receive the AirDuo® Digihaler™ at a dose that is equivalent to the participants' current inhaled therapy dose. Most participants will likely require the high dose inhaler: 232/14 device. This medication will be administered twice daily. The study and treatment will last 1 year. Participants will also use a home spirometry device and smart device application (app) will be used to track medication usage and allow users to self-assess their respiratory symptoms on a daily basis.
Participants will receive the ProAir® Digihaler™ 90mcg at a dose that is equivalent to the participants' current inhaled therapy dose. Most participants will likely require the high dose inhaler: 232/14 device. The ProAir® Digihaler™ will be utilized up to six times per day as needed for acute asthma symptoms. The study and treatment will last 1 year.