Teva Asthma Predictive Analytics Study

Study Overview
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Brief Summary
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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.

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

Conditions
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Asthma

Intervention / Treatment
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* Combination Product: AirDuo Digihaler
* Combination Product: ProAir Digihaler


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AirDuo and ProAir<br>This trial includes using the inhaler (AirDuo®) Digihaler™ and rescue inhalers (ProAir®) Digihaler™. | Combination Product: AirDuo Digihaler<br>* 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.<br>Combination Product: ProAir Digihaler<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean number of daily doses of ProAir® Digihaler™ |  | up to 1 year | 
| Mean number of daily doses AirDuo® Digihaler™. |  | up to 1 year | 
| Median 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Proportion of patients achieving non-response, partial and complete response to biologics |  | up to 1 year | 
| Change in mean peak inspiratory volume | Differences between the baseline and exacerbation measurements. | baseline to 1 year | 
| Change in mean inspiratory time | Differences between the baseline and exacerbation measurements. | baseline to 1 year | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adults, Severe persistent, AirDuo Digihaler, ProAir Digihaler