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Short-Acting Beta Agonist
Digihaler in Chronic Obstructive Pulmonary Disease (COPD)
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)
- Chronic Obstructive Pulmonary Disease
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
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 • NCT038906665%
Asthma
1%
COVID-19 pneumonia
1%
SARS-CoV-2 sepsis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Concurrent Control (CC)
Digital System (DS)
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
1,569 Previous Clinical Trials
4,319,653 Total Patients Enrolled
Wake Forest University Health SciencesOTHER
1,403 Previous Clinical Trials
2,478,281 Total Patients Enrolled
Teva Branded Pharmaceutical Products R&D, Inc.Industry Sponsor
256 Previous Clinical Trials
3,486,410 Total Patients Enrolled
Michael B Drummond, MDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill
4 Previous Clinical Trials
155 Total Patients Enrolled