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Short-Acting Beta Agonist

Albuterol eMDPI DS for Chronic Obstructive Pulmonary Disease

N/A
Waitlist Available
Led By Michael B Drummond, MD
Research Sponsored by University of North Carolina, Chapel Hill
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
All Individual Drugs Already Approved
Approved for 10 Other Conditions
No Placebo-Only Group

Summary

This trial tests the ProAir Digihaler, an advanced inhaler with a sensor, on adults with COPD who are at risk for worsening symptoms. The inhaler helps with breathing and provides data to improve usage techniques.

Eligible Conditions
  • Chronic Obstructive Pulmonary Disease (COPD)
  • Asthma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Mean Variability in Peak Inspiratory Flow (PIF)
Variability in Peak Inspiratory Flow (PIF) as Measured by Coefficient of Variation
Secondary study objectives
Correlation of Self-Reported Inhaler Use With Actual Inhaler Use
Mean Variability in Inhalation Volume
Variability in Inhalation Volume as Measured by Coefficient of Variation

Side effects data

From 2021 Phase 4 trial • 333 Patients • NCT03890666
7%
Asthma
1%
Ovarian cancer
100%
80%
60%
40%
20%
0%
Study treatment Arm
Digital System (DS)
Concurrent Control (CC)

Awards & Highlights

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.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Albuterol eMDPI DS (ProAir® Digihaler®)Experimental Treatment1 Intervention
This arm will receive the intervention of the Albuterol eMDPI DS for three months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Salbutamol
FDA approved

Find a Location

Who is running the clinical trial?

University of North Carolina, Chapel HillLead Sponsor
1,555 Previous Clinical Trials
4,298,479 Total Patients Enrolled
Wake Forest University Health SciencesOTHER
1,394 Previous Clinical Trials
2,459,982 Total Patients Enrolled
Teva Branded Pharmaceutical Products R&D, Inc.Industry Sponsor
256 Previous Clinical Trials
3,486,518 Total Patients Enrolled
~15 spots leftby Nov 2025
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