NCT04997304CompletedPhase 4
Teva Asthma Predictive Analytics Study
Utilizing Advances in Digital Inhaler Technology to Understand Heterogeneous Treatment Responses to Biologics in Severe Asthma
Source: ClinicalTrials.gov · Last updated 8 Jul 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 100 (actual)
- First submitted
- 11 Jul 2021
- Start date
- 9 Jul 2021
- Primary completion date
- 14 Dec 2023
- Lead sponsor
- University of Michigan
- Diseases
- Asthma
- NCT number
- NCT04997304
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 100
- From 9 Jul 2021 to the primary completion date, 14 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Michigan Coordinator of this site? Confirm its status | Ann Arbor | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.