CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 30 enrolled
Drug / intervention
Aclidinium bromide 400 μg bid +2 moredrug
Likely dose
Aclidinium bromide 400 μg bidfrom 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/NCT00868231
NCT00868231Phase 2Completed
CompareCT.gov

Efficacy of Aclidinium Bromide Administered in Chronic Obstructive Pulmonary Disease (COPD) Patients

AstraZeneca·interventional·Posted Mar 24, 2009·Updated Jan 4, 2017

In Brief

A Phase 2 clinical trial evaluating Aclidinium bromide 400 μg bid, Tiotropium 18 μg once-daily, and 1 other intervention for Chronic Obstructive Pulmonary Disease (COPD). Completed, enrolled 30 participants across 2 sites.

Detailed Summary

The main purpose of this study is to evaluate the efficacy, safety and tolerability of multiple doses of inhaled aclidinium bromide in moderate to severe COPD patients.

Study Details

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

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 24, 2009
Enrollment StartMar 1, 2009
Primary CompletionJul 1, 2009
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 17.3 years ago

Interventions

Aclidinium bromide 400 μg biddrug

Aclidinium bromide 400 μg twice-daily via inhalation by the Eklira Genuair® inhaler: 1 puff in the morning and evening for 15 days.

Tiotropium 18 μg once-dailydrug

Tiotropium 18 μg once-daily via inhalation by Handihaler® dry powder inhaler: 1 puff in the morning for 15 days.

Placebodrug

Inhaled placebo: 1 puff in the morning (placebo to tiotropium) or in the morning and evening (placebo to aclidnium) for 15 days.