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NCT04606394 · ClinicalTrials.gov registry record · Phase 4
Peak Inspiratory Flow and Dry Powder Inhaler Performance in COPD
A Phase 4 study of COPD, sponsored by Pulmonary Research Institute of Southeast Michigan.
- Completed
- Registry status
- Phase 4
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT04606394: Completed Phase 4 study of COPD, sponsored by Pulmonary Research Institute of Southeast Michigan.
NCT04606394 is a Phase 4 study of COPD that has completed, run by Pulmonary Research Institute of Southeast Michigan. The registered enrollment target is 30 participants, below the 2,418-participant average among 85 other COPD trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04606394, a Phase 4 study of COPD, has completed, sponsored by Pulmonary Research Institute of Southeast Michigan.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of the study is to determine whether PIF is clinically important when using the Ellipta DPI device. In addition, the study will validate the best/most clinically appropriate way to perform a PIF maneuver, to determine the testing capabilities of the preferred PIF maneuver and to relate this PIF measurement to meaningful clinical outcomes in COPD patients
Primary Outcome
Outcome = the number of subject test days (2 test days per subject) meeting responder criteria defined as: DPI Responder - a positive (\>50 ml) peak FEV1 response 2 hours after Trelegy Ellipta® DPI with a negative (\<50mL) peak FEV1 response 30 minutes after Ventolin® pMDI (2.5 hours post Trelegy) DPI Partial Responder a positive (\>50 ml) peak FEV1 response 2 hours after Trelegy® Ellipta DPI with a positive (\>50 ml) peak FEV1 response 30 minutes after Ventolin® pMDI (2.5 hours post Trelegy) D
Conditions Studied
Interventions
- DRUG Trelegy Ellipta 100/62.5/25Mcg Inh 30D
- DRUG Ventolin 90Mcg/Actuation Inhalation Aerosol
Study Locations (1)
Michigan
- Pulmonary Research Institute of Southeast Michigan - Farmington Hills
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2020-12-02 |
| Est. Completion | 2021-12-15 |
| Phase | Phase 4 |
What the finished NCT04606394 record still lists
NCT04606394 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 2,418-participant average among 85 other COPD trials with a reported enrollment target (99% lower).
The record links to 1 condition, with COPD appearing as the primary indexed condition, and to 2 interventions - of which Trelegy Ellipta 100/62.5/25Mcg Inh 30D is the first listed.
NCT04606394 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT04606394 about?
NCT04606394 is a clinical study titled "Peak Inspiratory Flow and Dry Powder Inhaler Performance in COPD". The purpose of the study is to determine whether PIF is clinically important when using the Ellipta DPI device. In addition, the study will validate the best/most clinically appropriate way to perform a PIF maneuver, to determine the testing capabilities of the preferred PIF maneuver and to relate t...
What is the current status of trial NCT04606394?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 30 participants. The study started on 2020-12-02. Estimated completion is 2021-12-15.
What conditions does trial NCT04606394 study?
This clinical trial studies the following conditions: COPD.
What interventions are being tested in trial NCT04606394?
The interventions under investigation include: Trelegy Ellipta 100/62.5/25Mcg Inh 30D (DRUG), Ventolin 90Mcg/Actuation Inhalation Aerosol (DRUG).
Who is sponsoring clinical trial NCT04606394?
This trial is sponsored by Pulmonary Research Institute of Southeast Michigan, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04606394 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for COPD
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04606394's enrollment target sits among peer trials
30 64th of 85 higher than 16 of 85 other COPD trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other COPD 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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