CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 24 enrolled
Drug / intervention
Aclidinium/formoterol 400/12μg +1 moredrug
Likely dose
Aclidinium/formoterol 400/12μgfrom 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/NCT01551888
NCT01551888Phase 2Completed
CompareCT.gov

A Phase 2a, Randomized, Open-Label, 2-Way Crossover Study To Determine The Pharmacokinetics, Safety, And Tolerability Of Aclidinium/Formoterol 400/12 µg Fixed Dose Combination Via Almirall Inhaler And Formoterol 12 µg Via Foradil® Aerolizer® In Patients With Moderate To Severe Chronic Obstructive Pulmonary Disease

AstraZeneca·interventional·Posted Mar 13, 2012·Updated Feb 14, 2017

In Brief

A Phase 2 clinical trial evaluating Aclidinium/formoterol 400/12μg and Formoterol for Chronic Obstructive Pulmonary Disease (COPD). Completed, enrolled 24 participants across 1 site.

Detailed Summary

The purpose of this Phase II study is to evaluate the pharmacokinetics, safety, and tolerability of aclidinium/formoterol fixed dose combination (FDC 400/12 μg via the Almirall Inhaler and formoterol 12 μg via the Foradil® Aerolizer®, both administered twice daily for five days to patients with moderate to severe COPD.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Obstructive Pulmonary Disease (COPD)
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMar 13, 2012
Enrollment StartJan 1, 2012
Primary CompletionMar 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 14.3 years ago

Interventions

Aclidinium/formoterol 400/12μgdrug

Aclidinium/formoterol 400/12μg fixed dose combination (FDC), one inhalation twice daily (morning and evening) for 4 days, then one inhalation (morning) on Day 5 via the Almirall inhaler

Formoteroldrug

Formoterol 12 μg one inhalation twice daily (morning and evening) for 4 days, then one inhalation (morning) on Day 5 via the Foradil® Aerolizer®