AsthmaPhase 4NCT04997304

Teva Asthma Predictive Analytics Study

A Phase 4 study testing AirDuo Digihaler and ProAir Digihaler in people with Asthma, run by University of Michigan at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Asthma
What is being tested?: AirDuo Digihaler and ProAir Digihaler
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 1 siteUnited States
Study dates: 9 Jul 2021to 14 Dec 2023
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Michigan
Ann Arbor, Michigan, 48109

Other trials in United States

About this study

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

Enrolled participants will complete questionnaires along with other study specific procedures. Additionally, in-person and phone visits will be performed.

Read the detailed description

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.

Conditions: Asthma
Being tested: AirDuo Digihaler, ProAir Digihaler
Keywords: Adults, Severe persistent, AirDuo Digihaler, ProAir Digihaler
Medical subject headings: Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AirDuo DigihalerCombination 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 DigihalerCombination 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.

Study groups in NCT04997304
Study group	Role	What they receive
AirDuo and ProAir	Experimental	This trial includes using the inhaler (AirDuo®) Digihaler™ and rescue inhalers (ProAir®) Digihaler™. Receives: Combination Product: AirDuo Digihaler; Combination Product: ProAir Digihaler

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: up to 1 year

Secondary outcomes (6)

Maintenace Inhaler Adherence Rates
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.
Measured: up to 1 year
Participants Who Achieved Non-response, Partial Response, and Complete Response to Biologics
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.
Measured: up to 1 year
Change in Mean Peak Inhalation Volume
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.
Measured: baseline to 1 year
Change in Mean Inspiratory Time
Inspiratory time was the total time taken to complete an inspiration (i.e., breathing in). Results were differences between the baseline and exacerbation measurements.
Measured: baseline to 1 year
Change in Mean Peak Inspiratory Flow (PIF)
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.
Measured: baseline up to 1 year
Change in Mean Forced Expiratory Volume in One Second (FEV1)
FEV1 was measured using the Go Spiro Spirometer. Results indicate the difference between the baseline and exacerbation measurements.
Measured: baseline up to 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Jul 202114 Dec 2023

First posted9 Aug 2021
Study start9 Jul 2021
Primary completion14 Dec 2023
Study completion14 Dec 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for AsthmaStudies of the same condition, open and under way.
More trials run by University of MichiganThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Health services research
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04997304
Sponsor's protocol ID: HUM00189756
Status last verified: Jun 2025
First submitted: 11 Jul 2021
Last updated: 8 Jul 2025
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Asthma trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Utilizing Advances in Digital Inhaler Technology to Understand Heterogeneous Treatment Responses to Biologics in Severe Asthma
ClinicalTrials.gov ID: NCT04997304
Acronym / sponsor ID: HUM00189756
Conditions: Asthma
Keywords: Adults, Severe persistent, AirDuo Digihaler, ProAir Digihaler
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: University of MichiganUniversity, hospital or other
Collaborators: Teva Branded Pharmaceutical Products R&D, Inc.
Study start: 9 Jul 2021 (actual)
Primary completion: 14 Dec 2023 (actual)
Study completion: 14 Dec 2023 (actual)
First posted: 9 Aug 2021 (actual)
Results: Posted 8 Jul 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Enrolled participants will complete questionnaires along with other study specific procedures. Additionally, in-person and phone visits will be performed.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
AirDuo and ProAir	Experimental	Combination Product: AirDuo Digihaler, Combination Product: ProAir DigihalerThis trial includes using the inhaler (AirDuo®) Digihaler™ and rescue inhalers (ProAir®) Digihaler™.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AirDuo DigihalerParticipants 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.	Combination product	AirDuo and ProAir
ProAir DigihalerParticipants 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.	Combination product	AirDuo and ProAir

Primary outcome

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.
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.
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.
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.

6 secondary outcomes

Maintenace Inhaler Adherence Rates
Time frame: up to 1 year
Participants Who Achieved Non-response, Partial Response, and Complete Response to Biologics
Time frame: up to 1 year
Change in Mean Peak Inhalation Volume
Time frame: baseline to 1 year
Change in Mean Inspiratory Time
Time frame: baseline to 1 year
Change in Mean Peak Inspiratory Flow (PIF)
Time frame: baseline up to 1 year
Change in Mean Forced Expiratory Volume in One Second (FEV1)
Time frame: baseline up to 1 year

Results and safety

Results posted to the registry on 8 Jul 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AirDuo and ProAir	100	74

Primary outcome: Mean Number of Daily Doses of ProAir® Digihaler™

Time frame: up to 1 year. Mean (Standard Deviation). Unit: doses per day

Measure	ProAir® Digihaler n = 100
Value	0.55 (0.95)

Population analysed: Because the outcome measure concerned adherence, all participants were included in this outcome, regardless of whether they chose to use the ProAir® Digihaler™.

Primary outcome: Mean Number of Daily Doses AirDuo® Digihaler™.

Time frame: up to 1 year. Mean (Standard Deviation). Unit: doses per day

Measure	AirDuo® Digihaler n = 100
Value	0.99 (0.76)

Population analysed: Because the outcome measure concerned adherence, all participants were included in this outcome, regardless of whether they chose to use the AirDuo® Digihaler™.

Primary outcome: Median Number of Daily Doses of ProAir® Digihaler™

Time frame: up to 1 year. Median (Inter-Quartile Range). Unit: doses per day

Measure	ProAir® Digihaler n = 100
Value	0.21 (0.03 to 0.52)

Population analysed: Because the outcome measure concerned adherence, all participants were included in this outcome, regardless of whether they chose to use the ProAir® Digihaler™.

Primary outcome: Median Number of Daily Doses of AirDuo® Digihaler™

Time frame: up to 1 year. Median (Inter-Quartile Range). Unit: doses per day

Measure	AirDuo® Digihaler n = 100
Value	0.99 (0.21 to 1.66)

Population analysed: Because the outcome measure concerned adherence, all participants were included in this outcome, regardless of whether they chose to use the AirDuo® Digihaler™.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 1 year. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Not Using Either AirDuo or ProAir	5 of 16 (31.3%)	7 of 16 (43.8%)	1 of 16
After Using AirDuo	0 of 84 (0%)	7 of 84 (8.3%)	0 of 84
After Using ProAir	2 of 73 (2.7%)	1 of 73 (1.4%)	0 of 73
After Using Both AirDuo and ProAir	8 of 73 (11%)	18 of 73 (24.7%)	0 of 73

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Asthma

Enrolling by invitationObservational study
Allergy, Asthma, and Atopic Eczema in Finland
Asthma, Asthma in Children
RecruitingPhase 2
Rademikibart IV for Acute Asthma and COPD Exacerbation
Asthma Acute, COPD Exacerbation Acute
Active, not recruiting
Community Health Equity Accelerator (CHEA) Pediatric Asthma Intervention
Asthma in Children
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
RecruitingObservational study
NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Njira Lugogo, MD principal investigator

University of Michigan

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing AirDuo Digihaler and ProAir Digihaler in people with Asthma, run by University of Michigan at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Number of Daily Doses of ProAir® Digihaler™ (time frame: up to 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04997304.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2025.