Teva Asthma Predictive Analytics Study

NCT04997304 | Completed Phase 4 Results FDA Drug

• 1 other identifier: HUM00189756
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Keywords

Adults; Severe persistent; AirDuo Digihaler; ProAir Digihaler

Outcome Measures

Primary Outcomes (4)

• Mean Number of Daily Doses of ProAir® Digihaler™

  This outcome measured participant adherence to using the ProAir® Digihaler™. All participants were provided the Digihaler device, which they could choose to use or not. Subject-specific result was calculated as the sum total of doses taken by participant divided by their number of days of follow-up.

  up to 1 year

• Mean Number of Daily Doses AirDuo® Digihaler™.

  This outcome measured participant adherence to using the AirDuo® Digihaler™. All participants were provided the Digihaler, which they could choose to use or not. Subject-specific result was calculated as the sum total of doses for a given participant divided by their number of days of follow-up.

  up to 1 year

• Median Number of Daily Doses of ProAir® Digihaler™

  This outcome measured participant adherence to using the ProAir® Digihaler™. All participants were provided the Digihaler, which they could choose to use or not. Subject-specific result was calculated as the 50th percentile value of all daily dose totals (or the average of two 50th percentile values if there was a tie) calculated over the number of days of follow-up.

  up to 1 year

• Median Number of Daily Doses of AirDuo® Digihaler™

  This outcome measured participant adherence to using the AirDuo® Digihaler™. All participants were provided the Digihaler, which they could choose to use or not. Subject-specific result was calculated as the 50th percentile value of all daily dose totals (or the average of two 50th percentile values if there was a tie) calculated over the number of days of follow-up.

  up to 1 year

Secondary Outcomes (6)

• Maintenace Inhaler Adherence Rates

  up to 1 year

• Participants Who Achieved Non-response, Partial Response, and Complete Response to Biologics

  up to 1 year

• Change in Mean Peak Inhalation Volume

  baseline to 1 year

• Change in Mean Inspiratory Time

  baseline to 1 year

• Change in Mean Peak Inspiratory Flow (PIF)

  baseline up to 1 year

Other Outcomes (4)

• Number of Exacerbations

  up to 1 year

• Number of Hospitalizations

  up to 1 year

• Number of Emergency Room Visits

  up to 1 year

Study Arms (1)

AirDuo and ProAir

EXPERIMENTAL

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

Combination Product: AirDuo Digihaler; Combination Product: ProAir Digihaler

Interventions

AirDuo Digihaler COMBINATION_PRODUCT

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.

AirDuo and ProAir

ProAir Digihaler COMBINATION_PRODUCT

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.

AirDuo and ProAir

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead
• Teva Branded Pharmaceutical Products R&D, Inc.: collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Asthma

Interventions

Albuterol

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

Results Point of Contact

• Title: Njira Lugogo
• Organization: University of Michigan

nlugogo@med.umich.edu

734-647-6477

Study Officials

• Njira Lugogo, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Internal Medicine

Study Record Dates

• First Submitted: July 11, 2021
• First Posted: August 9, 2021
• Study Start: July 9, 2021
• Primary Completion: December 14, 2023
• Study Completion: December 14, 2023
• Last Updated: July 8, 2025
• Results First Posted: July 8, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)