At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 590 enrolled
Drug / intervention
Aclidinium Bromide/Formoterol Fumarate +1 moredrug
Likely dose
Aclidinium Bromide/Formoterol Fumarate 400 μgfrom 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 Long-Term, Randomized, Study of the Safety and Tolerability of a Fixed-Dose Combination of Aclidinium Bromide/Formoterol Fumarate Compared With Formoterol Fumarate in Patients With Moderate to Severe, Stable Chronic Obstructive Pulmonary Disease (COPD)
In Brief
A Phase 3 clinical trial evaluating Aclidinium Bromide/Formoterol Fumarate and Formoterol Fumarate for Chronic Obstructive Pulmonary Disease. Completed, enrolled 590 participants across 137 sites.
Detailed Summary
The purpose of this study is to assess the long-term safety and tolerability of inhaled aclidinium bromide/formoterol in patients with moderate to severe, stable chronic obstructive pulmonary disease (COPD).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Obstructive Pulmonary Disease
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartSep 2011
First PostedSep 2011
Primary CompletionMar 2013
Study CompletionApr 2013
TodayJul 2026
First PostedSep 21, 2011
Enrollment StartSep 19, 2011
Primary CompletionMar 31, 2013
Study CompletionApr 30, 2013
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 14.8 years ago
Interventions
Aclidinium Bromide/Formoterol Fumaratedrug
Inhaled aclidinium bromide 400 μg/formoterol fumarate 12 μg, high dose twice per day
Formoterol Fumaratedrug
Inhaled formoterol fumarate 12 μg, twice per day