N/A
N=54
Digihaler in Chronic Obstructive Pulmonary Disease (COPD)
Pulmonary Disease, Chronic Obstructive
Bottom Line
View on ClinicalTrials.gov: NCT05241288 ↗Enrolled (actual)
54
Serious AEs
9.3%
Results posted
Jan 2024
Primary outcome: Primary: Mean Variability in Peak Inspiratory Flow (PIF) — 67.6 Liters/minute
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Albuterol eMDPI DS (Combination_product)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- Feb 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Variability in Peak Inspiratory Flow (PIF) |
67.6 | — |
| PRIMARY Variability in Peak Inspiratory Flow (PIF) as Measured by Coefficient of Variation |
0.286 | — |
| SECONDARY Correlation of Self-Reported Inhaler Use With Actual Inhaler Use |
-0.385 | — |
| SECONDARY Mean Variability in Inhalation Volume |
1.395 | — |
| SECONDARY Variability in Inhalation Volume as Measured by Coefficient of Variation |
0.426 | — |
Summary
This is a multi-center 3-month study to determine the variation in ProAir Digihaler metrics [peak inspiratory flow (PIF), inhalation volume, number of inhalation events] amongst COPD patients in the ambulatory setting.
Eligibility Criteria
Inclusion Criteria
- Age >40 years old
- History of cigarette smoking >=10 pack-years
- Established COPD defined as physician diagnosis along with spirometry confirmation [post-bronchodilator (BD) forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC)<0.70] within the last two years and an FEV1 ≤80% predicted
- Regular albuterol use (defined as at least one puff weekly for each of the last four weeks)
- Currently non-hospitalized
- Medical records confirmed history of two moderate AECOPD (defined as use of antibiotic or steroids to treat clinical event consistent with AECOPD) or one severe AECOPD (defined as emergency department/hospital visit) in prior 12 months
- Access to smart phone, tablet or computer and internet
- Willingness to switch current rescue inhaler/device to ProAir Digihaler
Exclusion Criteria
- Allergy or inability/contraindication to use Albuterol Sulfate
- Any condition that, in the opinion of the site investigator, would compromise the subject's ability to participate in the study
Data sourced from ClinicalTrials.gov (NCT05241288). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.