Teva Asthma Predictive Analytics Study

Asthma Clinical Trial

Official title:

Utilizing Advances in Digital Inhaler Technology to Understand Heterogeneous Treatment Responses to Biologics in Severe Asthma

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04997304
• Other study ID #: HUM00189756
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: July 9, 2021
• Est. completion date: September 2024

Study information

• Verified date: August 2023
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 101
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

Combination Product:
• AirDuo Digihaler
Patients will receive the AirDuo® Digihaler™ at a dose that is equivalent to the patients current inhaled therapy dose. Most patients 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.
• ProAir Digihaler
Patients will receive the ProAir® Digihaler™ 90mcg at a dose that is equivalent to the patients current inhaled therapy dose. Most patients 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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	Teva Branded Pharmaceutical Products R&D, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of exacerbations	This will be defined as an episode of acute worsening of asthma that requires at least 3 days of corticosteroids or a doubling dose of maintenance steroids.	up to 1 year
Other	Number of hospitalizations		up to 1 year
Other	Number of Emergency room visits		up to 1 year
Other	Mean asthma control test (ACT) score	Scored on a scale from 5 (poor control) -25 (excellent control), above 19 good control.	up to 1 year
Primary	Mean number of daily doses of ProAir® Digihaler™		up to 1 year
Primary	Mean number of daily doses AirDuo® Digihaler™.		up to 1 year
Primary	Median number of daily doses of ProAir® Digihaler™		up to 1 year
Primary	Median number of daily doses of AirDuo® Digihaler™		up to 1 year
Secondary	Proportion of patients with different adherence rates	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.	up to 1 year
Secondary	Proportion of patients achieving non-response, partial and complete response to biologics		up to 1 year
Secondary	Change in mean peak inspiratory volume	Differences between the baseline and exacerbation measurements.	baseline to 1 year
Secondary	Change in mean inspiratory time	Differences between the baseline and exacerbation measurements.	baseline to 1 year
Secondary	Change in mean Peak inspiratory flow (PIF)	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.	baseline up to 1 year
Secondary	Change in mean Forced expiratory volume in one second (FEV1)	FEV1 will be measured using the Go Spiro Spirometer. Differences between the baseline and exacerbation measurements.	baseline up to 1 year