At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 733 enrolled
Drug / intervention
CHF 5259 +2 moredrug
Likely dose
Tiotropium Bromide 18 µg Inhalation Capsulefrom 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.
A 6-week, Multicenter, Randomized, Double-blind, Placebo and Active-controlled, Parallel Group, Dose-ranging Study to Evaluate the Efficacy and Safety of 4 Doses of CHF 5259 pMDI (HFA Glycopyrronium Bromide Via Pressurized Metered Dose Inhaler) in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
In Brief
A Phase 2 clinical trial evaluating CHF 5259, Placebo, and 1 other intervention for COPD and Chronic Obstructive Pulmonary Disease. Completed, enrolled 733 participants across 112 sites.
Detailed Summary
The purpose of this study is to evaluate the dose-response of different doses of CHF 5259 pMDI on lung function and other clinical outcomes, to identify the optimal dose(s) in terms of benefit/ risk ratio for further development in the target subject population.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCOPD, Chronic Obstructive Pulmonary Disease
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedMar 2017
Enrollment StartJul 2017
Primary CompletionMay 2018
Study CompletionJun 2018
TodayJul 2026
First PostedMar 21, 2017
Enrollment StartJul 28, 2017
Primary CompletionMay 23, 2018
Study CompletionJun 6, 2018
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 9.3 years ago
Interventions
CHF 5259drug
Dose Response: Test one of four different doses of CHF 5259
Placebodrug
Placebo Control
Tiotropium Bromide 18 µg Inhalation Capsuledrug
Active Control