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Completed

NCT Number: NCT04997304

Teva Asthma Predictive Analytics Study

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

About this study

All participants were provided an AirDuo® Digihaler™ and ProAirDuo® Digihaler™, which the participants could choose to use or not. This trial did not restrict participants from using other asthma treatments in addition to or in lieu of the Digihalers.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Mean Number of Daily Doses of ProAir® Digihaler™

    Time frame: up to 1 year

    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.

  2. Mean Number of Daily Doses AirDuo® Digihaler™.

    Time frame: up to 1 year

    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.

  3. Median Number of Daily Doses of ProAir® Digihaler™

    Time frame: up to 1 year

    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.

  4. Median Number of Daily Doses of AirDuo® Digihaler™

    Time frame: up to 1 year

    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.

Secondary outcomes

  1. Maintenace Inhaler Adherence Rates

    Time frame: up to 1 year

    This outcome measured participant adherence to using the AirDuo® Digihaler™. All participants were provided the Digihaler, which they could choose to use or not. Adherence rates were measured by the following: High (>80% of puffs), moderate (50-80% of puffs), and low levels (<50% of puffs) of adherence to maintenance inhalers over the course of the trial.

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

    Time frame: up to 1 year

    All participants were provided the AirDuo® and ProAir® Digihalers, which they could choose to use or not. Responses were categorized as non-response, partial response, and complete response on the basis of five factors: a 50% reduction in exacerbations, any reduction in maintenance oral corticosteroids (OCS) dose, change of at least 10% in forced expiratory volume in one second (FEV1), improvement of 3 points in asthma control test (ACT) score, and patient perception of global improvement in asthma. Non-response indicated that a participant had no response to any of the 5 factors. Partial response indicated that a participant responded to at least 1 factor. Complete response indicated that a participant responded to all 5 factors.

  3. Change in Mean Peak Inhalation Volume

    Time frame: baseline to 1 year

    Peak inhalation volume is the maximum air volume a person can breathe in during a deep inhalation, serving as an indicator of lung capacity and respiratory function. Peak inhalation volume was measured by the digital inhaler at the end of inhalation. This measures the maximum volume that the participant was able to draw into their lungs. Larger numbers indicated healthier lungs.

  4. Change in Mean Inspiratory Time

    Time frame: baseline to 1 year

    Inspiratory time was the total time taken to complete an inspiration (i.e., breathing in). Results were differences between the baseline and exacerbation measurements.

  5. Change in Mean Peak Inspiratory Flow (PIF)

    Time frame: baseline up to 1 year

    PIF is the maximum rate of airflow a person can inhale using an inhaler after a full breath. PIF was measured by the ProAir® Digihaler™ and AirDuo® Digihaler™. Results indicate the changes between the baseline and exacerbation measurements.

  6. Change in Mean Forced Expiratory Volume in One Second (FEV1)

    Time frame: baseline up to 1 year

    FEV1 was measured using the Go Spiro Spirometer. Results indicate the difference between the baseline and exacerbation measurements.

Other outcomes

  1. Number of Exacerbations

    Time frame: up to 1 year

  2. Number of Hospitalizations

    Time frame: up to 1 year

  3. Number of Emergency Room Visits

    Time frame: up to 1 year

  4. Mean Asthma Control Test (ACT) Score

    Time frame: up to 1 year

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • Teva Branded Pharmaceutical Products R&D, Inc.

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Aug 9, 2021
Registry last updated
Jul 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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