search
Back to results

Teva Asthma Predictive Analytics Study

Primary Purpose

Asthma

Status
Active
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
AirDuo Digihaler
ProAir Digihaler
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Asthma focused on measuring Adults, Severe persistent, AirDuo Digihaler, ProAir Digihaler

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Michigan

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AirDuo and ProAir

Arm Description

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

Outcomes

Primary Outcome Measures

Mean number of daily doses of ProAir® Digihaler™
Mean number of daily doses AirDuo® Digihaler™.
Median number of daily doses of ProAir® Digihaler™
Median number of daily doses of AirDuo® Digihaler™

Secondary Outcome Measures

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.
Proportion of patients achieving non-response, partial and complete response to biologics
Change in mean peak inspiratory volume
Differences between the baseline and exacerbation measurements.
Change in mean inspiratory time
Differences between the baseline and exacerbation measurements.
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.
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.

Full Information

First Posted
July 11, 2021
Last Updated
August 7, 2023
Sponsor
University of Michigan
Collaborators
Teva Branded Pharmaceutical Products R&D, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT04997304
Brief Title
Teva Asthma Predictive Analytics Study
Official Title
Utilizing Advances in Digital Inhaler Technology to Understand Heterogeneous Treatment Responses to Biologics in Severe Asthma
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 9, 2021 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
Teva Branded Pharmaceutical Products R&D, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Adults, Severe persistent, AirDuo Digihaler, ProAir Digihaler

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
101 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AirDuo and ProAir
Arm Type
Experimental
Arm Description
This trial includes using the inhaler (AirDuo®) Digihaler™ and rescue inhalers (ProAir®) Digihaler™.
Intervention Type
Combination Product
Intervention Name(s)
AirDuo Digihaler
Intervention Description
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.
Intervention Type
Combination Product
Intervention Name(s)
ProAir Digihaler
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mean number of daily doses of ProAir® Digihaler™
Time Frame
up to 1 year
Title
Mean number of daily doses AirDuo® Digihaler™.
Time Frame
up to 1 year
Title
Median number of daily doses of ProAir® Digihaler™
Time Frame
up to 1 year
Title
Median number of daily doses of AirDuo® Digihaler™
Time Frame
up to 1 year
Secondary Outcome Measure Information:
Title
Proportion of patients with different adherence rates
Description
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.
Time Frame
up to 1 year
Title
Proportion of patients achieving non-response, partial and complete response to biologics
Time Frame
up to 1 year
Title
Change in mean peak inspiratory volume
Description
Differences between the baseline and exacerbation measurements.
Time Frame
baseline to 1 year
Title
Change in mean inspiratory time
Description
Differences between the baseline and exacerbation measurements.
Time Frame
baseline to 1 year
Title
Change in mean Peak inspiratory flow (PIF)
Description
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.
Time Frame
baseline up to 1 year
Title
Change in mean Forced expiratory volume in one second (FEV1)
Description
FEV1 will be measured using the Go Spiro Spirometer. Differences between the baseline and exacerbation measurements.
Time Frame
baseline up to 1 year
Other Pre-specified Outcome Measures:
Title
Number of exacerbations
Description
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.
Time Frame
up to 1 year
Title
Number of hospitalizations
Time Frame
up to 1 year
Title
Number of Emergency room visits
Time Frame
up to 1 year
Title
Mean asthma control test (ACT) score
Description
Scored on a scale from 5 (poor control) -25 (excellent control), above 19 good control.
Time Frame
up to 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Njira Lugogo, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Teva Asthma Predictive Analytics Study

We'll reach out to this number within 24 hrs