Clinical trial NCT04997304: Teva Asthma Predictive Analytics Study
Official title: Utilizing Advances in Digital Inhaler Technology to Understand Heterogeneous Treatment Responses to Biologics in Severe Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Keywords: Adults
Severe persistent
AirDuo Digihaler
ProAir Digihaler
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Teva Branded Pharmaceutical Products R&D, Inc.
First posted: 2021-08-09
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Mean number of daily doses of ProAir® Digihaler™
timeFrame: up to 1 year
measure: Mean number of daily doses AirDuo® Digihaler™.
timeFrame: up to 1 year
measure: Median number of daily doses of ProAir® Digihaler™
timeFrame: up to 1 year
measure: Median number of daily doses of AirDuo® Digihaler™
timeFrame: up to 1 year
Secondary outcomes:
measure: Proportion of patients with different adherence rates
timeFrame: up to 1 year
measure: Proportion of patients achieving non-response, partial and complete response to biologics
timeFrame: up to 1 year
measure: Change in mean peak inspiratory volume
timeFrame: baseline to 1 year
measure: Change in mean inspiratory time
timeFrame: baseline to 1 year
measure: Change in mean Peak inspiratory flow (PIF)
timeFrame: baseline up to 1 year
measure: Change in mean Forced expiratory volume in one second (FEV1)
timeFrame: baseline up to 1 year
Other outcomes:
measure: Number of exacerbations
timeFrame: up to 1 year
measure: Number of hospitalizations
timeFrame: up to 1 year
measure: Number of Emergency room visits
timeFrame: up to 1 year
measure: Mean asthma control test (ACT) score
timeFrame: up to 1 year
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Njira Lugogo, MD
role: PRINCIPAL_INVESTIGATOR
References: