CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 30 enrolled
Drug / intervention
Trelegy Ellipta 100/62.5/25Mcg Inh 30D +1 moredrug
Likely dose
Trelegy Ellipta 100/62.5/25Mcg Inh 30Dfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04606394
NCT04606394Phase 4Completed
CompareCT.gov

Peak Inspiratory Flow (PIF) and Dry Powder Inhaler (DPI) Performance in Chronic Obstructive Pulmonary Disease (COPD)

Pulmonary Research Institute of Southeast Michigan·interventional·Posted Oct 28, 2020·Updated May 8, 2023

In Brief

A Phase 4 clinical trial evaluating Trelegy Ellipta 100/62.5/25Mcg Inh 30D and Ventolin 90Mcg/Actuation Inhalation Aerosol for COPD. Completed, enrolled 30 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCOPD
CountriesUnited States
CollaboratorsGlaxoSmithKline

Timeline

Phase 4CompletedFinished
202120222023202420252026
First PostedOct 28, 2020
Enrollment StartDec 2, 2020
Primary CompletionDec 15, 2021
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 5.7 years ago

Interventions

Trelegy Ellipta 100/62.5/25Mcg Inh 30Ddrug

Administration of Trelegy in all patients

Ventolin 90Mcg/Actuation Inhalation Aerosoldrug

2 hours after the administration of Trelegy, administer Ventolin in all patients