Teva Asthma Predictive Analytics Study

Phase 4

Completed

• Conditions: Asthma
• Interventions: Combination Product: AirDuo Digihaler; Combination Product: ProAir Digihaler

• Registration Number: NCT04997304
• Lead Sponsor: University of Michigan

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2021-07-09
• Study First Submitted: 2021-07-11
• Study First Submitted QC: 2021-08-02
• Study First Posted: 2021-08-09
• Primary Completion: 2023-12-14
• Study Completion: 2023-12-14
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-07
• Last Update Posted: 2024-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AirDuo and ProAir	ProAir Digihaler	This trial includes using the inhaler (AirDuo®) Digihaler™ and rescue inhalers (ProAir®) Digihaler™.
AirDuo and ProAir	AirDuo Digihaler	This trial includes using the inhaler (AirDuo®) Digihaler™ and rescue inhalers (ProAir®) Digihaler™.

Primary Outcome Measures

Name	Time	Method
Median number of daily doses of ProAir® Digihaler™	up to 1 year
Mean number of daily doses AirDuo® Digihaler™.	up to 1 year
Mean number of daily doses of ProAir® Digihaler™	up to 1 year
Median number of daily doses of AirDuo® Digihaler™	up to 1 year

Secondary Outcome Measures

Name	Time	Method
Change in mean inspiratory time	baseline to 1 year	Differences between the baseline and exacerbation measurements.
Proportion of patients with different adherence rates	up to 1 year	The adherence rates will be measured by the following: High (\>80% of puffs), moderate (50-80% of puffs), and low levels (\<50% of puffs) of adherence to maintenance inhalers.
Proportion of patients achieving non-response, partial and complete response to biologics	up to 1 year
Change in mean peak inspiratory volume	baseline to 1 year	Differences between the baseline and exacerbation measurements.
Change in mean Peak inspiratory flow (PIF)	baseline up to 1 year	PIF will be measured by the ProAir® Digihaler™ and AirDuo® Digihaler™ as well as the Go Spiro Spirometer. Differences between the baseline and exacerbation measurements.
Change in mean Forced expiratory volume in one second (FEV1)	baseline up to 1 year	FEV1 will be measured using the Go Spiro Spirometer. Differences between the baseline and exacerbation measurements.

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States