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AirDuo Digihaler for Asthma

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
University of Michigan, Ann Arbor, MIAsthmaAirDuo Digihaler - CombinationProduct
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

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Study Objectives

4 Primary · 6 Secondary · Reporting Duration: up to 1 year

baseline to 1 year
Change in mean inspiratory time
Change in mean peak inspiratory volume
Year 1
Change in mean Forced expiratory volume in one second (FEV1)
Change in mean Peak inspiratory flow (PIF)
up to 1 year
Mean asthma control test (ACT) score
Mean number of daily doses AirDuo® Digihaler™.
Mean number of daily doses of ProAir® Digihaler™
Median number of daily doses of AirDuo® Digihaler™
Pro-Air Procaterol
Number of Emergency room visits
Number of exacerbations
Number of hospitalizations
Proportion of patients achieving non-response, partial and complete response to biologics
Proportion of patients with different adherence rates

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Similar Trials

1
Roflumilast
1
As needed inhaled corticosteroid and long-acting beta-agonist
1
Glycine Buffer

Trial Design

1 Treatment Group

AirDuo and ProAir
1 of 1

Experimental Treatment

100 Total Participants · 1 Treatment Group

Primary Treatment: AirDuo Digihaler · No Placebo Group · Phase 4

AirDuo and ProAirExperimental Group · 2 Interventions: AirDuo Digihaler, ProAir Digihaler · Intervention Types: CombinationProduct, CombinationProduct

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 1 year

Who is running the clinical trial?

University of MichiganLead Sponsor
1,647 Previous Clinical Trials
6,420,345 Total Patients Enrolled
16 Trials studying Asthma
4,976 Patients Enrolled for Asthma
Teva Branded Pharmaceutical Products R&D, Inc.Industry Sponsor
244 Previous Clinical Trials
3,482,783 Total Patients Enrolled
61 Trials studying Asthma
2,613,892 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

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are currently taking or planning to start using biologic drugs after joining the study.
You are willing to switch to AirDuo Digihaler and use ProAir Digihaler for emergencies. You should avoid using nebulized albuterol but it is not strictly prohibited.
If you have asthma, your level of control will be assessed using a test. If your score is below a certain number, it means your asthma is not well controlled. The study will only accept a certain percentage of participants who have well-controlled asthma. Once that percentage is reached, no more participants with well-controlled asthma will be enrolled.

Who else is applying?

What state do they live in?
Michigan100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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