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NCT04168775 · ClinicalTrials.gov registry record · NA
Peak Inspiratory Flow Rates in Patients With COPD
A NA study, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- NA
- Development phase
- 80
- Enrollment target
NCT04168775: Completed NA study, sponsored by University of North Carolina, Chapel Hill.
NCT04168775 is a NA study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 80 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04168775, a NA study, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- NA
- Development phase
- 80 participants
- Enrollment target
Study Summary
Recent studies have reported that some Chronic Obstructive Pulmonary Disease (COPD) patients may have a suboptimal ability to generate a sufficient inspiratory effort to achieve adequate lung delivery of inhaled medications through dry powder inhalers. Sparse data is available about the inspiratory capacity of these patients in the home setting, whether clinically stable or when experiencing worsened respiratory symptoms outside the acute care setting. This study is undertaken to better understand the proportion of patients with suboptimal peak inspiratory flow rate (sPIFR) measurements amongst COPD patients receiving dry powder inhaler(s) (DPI) in the ambulatory setting. Further, the study will characterize PIFR over time, the variability of PIFR measurements, and the associations with potential predictors (demographics, clinical, Patient-Reported Outcomes (PRO), body position, and device) as well as exacerbations frequency and change in PIFR around period of exacerbation.
Primary Outcome
The occurrence of suboptimal Peak Inspiratory Flow Rate (sPIFR) over 24 weeks. sPIFR will be defined as any two consecutive measurements on different days below the optimal threshold for any prescribed DPI (e.g.,\<30 L/min for Handihaler® (High resistance DPI), \<60 L/min for Ellipta® (Medium resistance DPI))
Interventions
- DEVICE Home PIFR monitoring with InCheck Dial
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2019-07-31 |
| Est. Completion | 2022-04-26 |
| Phase | NA |
What the finished NCT04168775 record still lists
NCT04168775 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 1 intervention - of which Home PIFR monitoring with InCheck Dial is the first listed.
NCT04168775 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04168775 about?
NCT04168775 is a clinical study titled "Peak Inspiratory Flow Rates in Patients With COPD". Recent studies have reported that some Chronic Obstructive Pulmonary Disease (COPD) patients may have a suboptimal ability to generate a sufficient inspiratory effort to achieve adequate lung delivery of inhaled medications through dry powder inhalers. Sparse data is available about the inspiratory ...
What is the current status of trial NCT04168775?
This trial is currently completed. It is a NA study. The enrollment target is 80 participants. The study started on 2019-07-31. Estimated completion is 2022-04-26.
What interventions are being tested in trial NCT04168775?
The interventions under investigation include: Home PIFR monitoring with InCheck Dial (DEVICE).
Who is sponsoring clinical trial NCT04168775?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04168775's enrollment target sits among peer trials
80 994th of 2000 higher than 941 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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