CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 300 enrolled
Drug / intervention
Aclidinium Bromide +1 moredrug
Likely dose
Aclidinium Bromide 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.

Search/NCT02375724
NCT02375724Phase 4Completed
CompareCT.gov

A RANDOMISED, DOUBLE BLIND, PLACEBO CONTROLLED, PARALLEL STUDY TO ASSESS THE BENEFITS OF ACLIDINIUM BROMIDE IN THE RELIEF OF COPD SYMPTOMS INCLUDING COUGH WHEN ADMINISTERED TO PATIENTS WITH COPD

AstraZeneca·interventional·Posted Mar 3, 2015·Updated Apr 21, 2017

In Brief

A Phase 4 clinical trial evaluating Aclidinium Bromide and Placebo for Pulmonary Disease, Chronic Obstructive. Completed, enrolled 300 participants across 24 sites in 5 countries.

Detailed Summary

The aim of the present study is to evaluate the effect of aclidinium bromide 400 μg BID compared with placebo on COPD symptoms in a symptomatic patients population with moderate COPD and chronic bronchitis, and particularly assess the effects in cough by using specific tools to assess the occurrence and impact of this relevant COPD symptom.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Disease, Chronic Obstructive
CountriesGermany, Hungary, Italy, Spain, United Kingdom
CollaboratorsMenarini Group

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMar 3, 2015
Enrollment StartMar 1, 2015
Primary CompletionNov 1, 2015
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 11.3 years ago

Interventions

Aclidinium Bromidedrug

Inhaled Aclidinium 400 μg twice per day by Eklira Genuair Inhaler

Placebodrug

Inhaled dose-matched placebo, twice per day by Eklira Genuair Inhaler