CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,595 enrolled
Drug / intervention
Aclidinium bromide 400 μg/Formoterol Fumarate 12 μg (AB/FF 400/12 μg) +5 moredrug
Likely dose
Aclidinium bromide 400 μg/Formoterol Fumarate 12 μg (AB/FF 400/12 μg)from 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/NCT02796677
NCT02796677Phase 3Completed
CompareCT.gov

A 24 Week Treatment, Multicenter, Randomized, Double Blinded, Double Dummy, Parallel-group, Clinical Trial Evaluating the Efficacy and Safety of Aclidinium Bromide 400 μg/Formoterol Fumarate 12 μg Fixed-dose Combination BID Compared With Each Monotherapy (Aclidinium Bromide 400 μg BID and Formoterol Fumarate 12 μg BID) and Tiotropium 18 μg QD When Administered to Patients With Stable Chronic Obstructive Pulmonary Disease.

AstraZeneca·interventional·Posted Jun 13, 2016·Updated Nov 9, 2018

In Brief

A Phase 3 clinical trial evaluating Aclidinium bromide 400 μg/Formoterol Fumarate 12 μg (AB/FF 400/12 μg), Aclidinium bromide 400 μg (AB 400 μg), and 4 other interventions for Chronic Obstructive Pulmonary Disease. Completed, enrolled 1,595 participants across 163 sites in 10 countries.

Detailed Summary

This is a multiple dose, randomized, parallel, double-blind, double-dummy, multicenter and multinational Phase III study to determine the efficacy and safety of Aclidinium bromide 400μg/Formoterol Fumarate (AB/FF) 12 μg compared to individual components and TIO (Tiotropium) 18 μg when administered to patients with stable chronic obstructive pulmonary disease (COPD).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Obstructive Pulmonary Disease
CountriesBulgaria, Czechia, Germany, Hungary, Israel, Poland, Spain, Ukraine, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedJun 13, 2016
Enrollment StartJul 5, 2016
Primary CompletionJun 8, 2017
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 10.1 years ago

Interventions

Aclidinium bromide 400 μg/Formoterol Fumarate 12 μg (AB/FF 400/12 μg)drug

Inhalation powder

Aclidinium bromide 400 μg (AB 400 μg)drug

Inhalation powder

Formoterol fumarate 12 μg (FF 12 μg)drug

Inhalation powder

Placebo to AB/FF 400/12 μg, AB 400 μg and FF 12 μgother

Inhalation powder

Tiotropium 18 μg (TIO 18 μg)drug

Powder in capsules for oral inhalation

Placebo to TIO 18 μgother

Powder in capsules for oral inhalation