CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 97 enrolled
Drug / intervention
Breezhaler® +2 moredevice
Likely dose
Not stated in 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/NCT02596009
NCT02596009Phase 4Completed

Multicenter Open-label Cross-over Study to Compare Inspiratory Flow Rates Achieved by the COPD Patients Through Breezhaler®, Ellipta® and Handihaler® Dry Powder Inhaler Devices

Novartis Pharmaceuticals·interventional·Posted Nov 4, 2015·Updated Jun 26, 2018

In Brief

A Phase 4 clinical trial evaluating Breezhaler®, Ellipta®, and 1 other intervention for Pulmonary Disease, Chronic Obstructive (COPD). Completed, enrolled 97 participants across 5 sites.

Detailed Summary

The purpose of this study was to compare dynamic inspiratory flow rates achieved by a population of Chronic Obstructive Pulmonary Disease (COPD) patients through the Breezhaler®, Ellipta® and Handihaler® dry powder inhaler (DPI) devices. No active drug or placebo were administered to patients in this study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesArgentina
Collaborators--

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedNov 4, 2015
Enrollment StartDec 16, 2015
Primary CompletionApr 29, 2016
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 10.7 years ago

Interventions

Breezhaler®device

No active drug or placebo were administered to patients during this study. Each patient were required to inhale via all three (03) study devices (Breezhaler®, Ellipta® and Handihaler®). Each patient was required to produce at least three (03) inhalational profiles via each inhalational device, following the training and demonstration for correct inhalational procedure, for each device.

Ellipta®device

No active drug or placebo were administered to patients during this study. Each patient were required to inhale via all three (03) study devices (Breezhaler®, Ellipta® and Handihaler®). Each patient was required to produce at least three (03) inhalational profiles via each inhalational device, following the training and demonstration for correct inhalational procedure, for each device.

Handihaler®device

No active drug or placebo were administered to patients during this study. Each patient were required to inhale via all three (03) study devices (Breezhaler®, Ellipta® and Handihaler®). Each patient was required to produce at least three (03) inhalational profiles via each inhalational device, following the training and demonstration for correct inhalational procedure, for each device.