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Combination Product
Digital Inhalers for Asthma
Phase 4
Waitlist Available
Led By Njira Lugogo, MD
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
Study Summary
This trial is being done to see how well patients with asthma respond to treatment with TEVA digital inhalers. Data from these devices will be used to help predict asthma exacerbations and response to biologics.
Who is the study for?
This trial is for asthma patients with poor control of their condition, willing to switch to TEVA digital inhalers. Participants must be able to use a smart device and app, may be using or starting biologics, and should have severe persistent asthma as defined by ERS/ATS criteria. Excluded are those with unstable conditions, drug abuse history, immunodeficiencies, life-threatening diseases other than asthma or recent malignancies.Check my eligibility
What is being tested?
The study aims to develop predictive models for asthma exacerbations and response to biologics using data from TEVA's ProAir Digihaler for rescue therapy and AirDuo Digihaler for maintenance. It involves questionnaires, in-person visits, phone check-ins and monitoring inhalation patterns through the digital devices.See study design
What are the potential side effects?
While specific side effects aren't listed here since it's more about data collection from digital inhalers rather than testing new drugs; typical inhaler side effects can include throat irritation, headache, coughing or respiratory infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have severe asthma that hasn't improved with strong asthma medications.
Select...
I am currently using or plan to use biologic therapy after joining the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Mean number of daily doses AirDuo® Digihaler™.
Mean number of daily doses of ProAir® Digihaler™
Median number of daily doses of AirDuo® Digihaler™
+1 moreSecondary outcome measures
Change in mean Forced expiratory volume in one second (FEV1)
Change in mean Peak inspiratory flow (PIF)
Change in mean inspiratory time
+3 moreOther outcome measures
Mean asthma control test (ACT) score
Number of Emergency room visits
Number of exacerbations
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: AirDuo and ProAirExperimental Treatment2 Interventions
This trial includes using the inhaler (AirDuo®) Digihaler™ and rescue inhalers (ProAir®) Digihaler™.
Find a Location
Who is running the clinical trial?
University of MichiganLead Sponsor
1,794 Previous Clinical Trials
6,373,815 Total Patients Enrolled
17 Trials studying Asthma
5,152 Patients Enrolled for Asthma
Teva Branded Pharmaceutical Products R&D, Inc.Industry Sponsor
251 Previous Clinical Trials
3,485,275 Total Patients Enrolled
63 Trials studying Asthma
2,616,110 Patients Enrolled for Asthma
Njira Lugogo, MDPrincipal Investigator - University of Michigan
University of Michigan C.S. Mott Children's Hospital, University of Michigan Hospital, Von Voigtlander Women's Hospital
Virginia Commonwealth University (Medical School)
Duke University Medical Center (Residency)
2 Previous Clinical Trials
40,743 Total Patients Enrolled
2 Trials studying Asthma
40,743 Patients Enrolled for Asthma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a significant lung condition other than asthma.My asthma control score is below 19, indicating poor control.My health condition is stable and won't affect my participation in the study.I am willing to change my inhalers to AirDuo and ProAir Digihaler.I do not have any severe illnesses that could stop me from completing a 12-month study.I have severe asthma that hasn't improved with strong asthma medications.You have a history of drinking too much alcohol or using drugs regularly.I am currently using or plan to use biologic therapy after joining the study.I have HIV or another immune system condition.I have had a cancer, other than skin cancer, in the past year that affects my survival.
Research Study Groups:
This trial has the following groups:- Group 1: AirDuo and ProAir
Awards:
This trial has 5 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What medical condition is AirDuo Digihaler typically employed to address?
"The AirDuo Digihaler is prescribed to those suffering from bronchodilator agents, as well as rhinorrhoea, seasonal allergic rhinitis and chronic bronchitis."
Answered by AI
Has the AirDuo Digihaler been granted authorization from the FDA?
"AirDuo Digihaler has been approved by the relevant governing bodies, so it is rated 3 out of 3 on our safety scale."
Answered by AI
Are there currently any spots available for enrollment in this clinical trial?
"Affirmative. The information hosted on clinicaltrials.gov indicates that this medical experiment, which was initially announced on July 9th 2021, is at present looking for participants. A total of 100 patients will be enrolled from a single site."
Answered by AI
Can you tell me more about the past studies conducted on AirDuo Digihaler?
"Currently, there are 26 medical trials being conducted to evaluate the efficacy of AirDuo Digihaler. Two of these studies have reached Phase 3 and most take place in Ann Arbor, Michigan. Across all 88 sites running this trial, patients can participate."
Answered by AI
What is the total enrollment of this trial?
"Affirmative. Clinicaltrials.gov data shows that the study, first introduced on July 9th 2021, is currently recruiting patients. The project seeks to find 100 volunteers from a single medical centre."
Answered by AI
Who else is applying?
What state do they live in?
Michigan
What portion of applicants met pre-screening criteria?
Met criteria
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