Teva Asthma Predictive Analytics Study

University of Michigan

Status and phase

Completed

Phase 4

Conditions

Asthma

Treatments

Combination Product: ProAir Digihaler

Combination Product: AirDuo Digihaler

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04997304

HUM00189756

Details and patient eligibility

About

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.

Enrollment

101 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

A history of severe persistent asthma as defined by European Respiratory Society (ERS) and American Thoracic Society (ERS/ATS) criteria which includes the presence of poor asthma control on high dose inhaled corticosteroid (ICS) and a long-acting beta-agonist (CS/LABA) or the need for high dose ICS/LABA to maintain asthma control or oral steroids for maintenance therapy for more than 50% of the prior year.
Presence of current biologic use or planned initiation of biologics following study enrollment
Patients will be categorized on the basis of asthma control (Asthma Control Test (ACT)< 19 will be considered poor asthma control). The study will cap the patients with good asthma control at 30% and will no longer enroll those patients once the strata have been fully enrolled.
Willingness to switch maintenance inhalers to AirDuo® Digihaler™ and to use ProAir® Digihaler™ for rescue therapy. Use of nebulized albuterol will be discouraged but not prohibited.
Can read and communicate in English and is familiar with and is willing to use his/her own smart device and download and use the study application
Ability to provide informed consent.
The patient must be willing and able to comply with study requirements and restrictions

Exclusion criteria

Clinically important pulmonary disease other than asthma including Chronic obstructive pulmonary disease (COPD), bronchiectasis, pulmonary fibrosis, cystic fibrosis, or other lung disease
Any disorder that is either not stable or could in the opinion of the investigator affect the ability of the subject to safely participate in the study or could adversely affect study results.
History of human immunodeficiency virus or other immunodeficiency syndrome
Malignancy other than skin cancer that has occurred within the past year and that will impact survival thus limit participation in the clinical trial
History of chronic alcohol abuse or drug use
Any life-threatening diseases that will impact the patient's ability to complete the 12-month study period