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Efficacy and Safety of Aclidinium Bromide at Two Dose Levels Versus Placebo Administered in Chronic Obstructive Pulmonary Disease (COPD) Patients

Efficacy and Safety of Aclidinium Bromide at Two Dose Levels vs Placebo When Administered to Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

NCT01001494•AstraZeneca

View on ClinicalTrials.gov

Summary

The main purpose of this study is to assess the long term bronchodilator efficacy, safety and tolerability of inhaled aclidinium bromide at two dose levels compared to placebo in COPD patients and the benefits of the product in disease-related health status, COPD symptoms and COPD exacerbations.

Eligibility

Age

40 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Adult male and female patients aged ≥40 with stable moderate to severe COPD (GOLD guidelines).
•Post-salbutamol (FEV1) \< 80% and ≥30% of predicted normal value and Post-salbutamol FEV1/FVC \< 70%.
•Current or ex-smokers of ≥10 pack-years.

Exclusion Criteria

•Patients with no history or current diagnosis of asthma.
•No evidence of an exacerbation within 6 weeks prior to the screening visit.
•No evidence of clinically significant respiratory and/or cardiovascular conditions or laboratory abnormalities.
•No contraindication to use of anticholinergic drugs such as known symptomatic prostatic hypertrophy, bladder neck obstruction or narrow-angle glaucoma.

Locations (106)

Almirall Investigational Sites#4

Benešov, Czechia

Almirall Investigational Sites#9

Jaroměř, Czechia

Almirall Investigational Sites#3

Liberec, Czechia

Almirall Investigational Sites#2

Lovosice, Czechia

Almirall Investigational Sites#1

Neratovice, Czechia

Almirall Investigational Sites#11

Prague, Czechia

Almirall Investigational Sites#6

Prague, Czechia

Almirall Investigational Sites#12

Prague, Czechia

Almirall Investigational Sites#7

Prague, Czechia

Almirall Investigational Sites#10

Strakonice, Czechia

Key Dates

Start Date

October 1, 2009

Primary Completion Date

November 1, 2010

Completion Date

November 1, 2010

Last Updated

January 4, 2017

Enrollment

828

ACTUAL participants

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Interventions

Aclidinium bromide 200 μg bid

DRUG

Aclidinium bromide 400 μg bid

DRUG

Placebo

DRUG

cfMSC Stem Cell Therapy Targeting COPD

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RECRUITINGNA

A Clinical Study of Inhaled Nitric Oxide in Patients With Chronic Obstructive Pulmonary Disease

NCT07382258

Chronic Obstructive Pulmonary Disease (COPD)

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RECRUITINGNA

Mindful-Breath for People With COPD

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 4, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Efficacy and Safety of Aclidinium Bromide at Two Dose Levels Versus Placebo Administered in Chronic Obstructive Pulmonary Disease (COPD) Patients

Inclusion Criteria

Exclusion Criteria

cfMSC Stem Cell Therapy Targeting COPD

A Clinical Study of Inhaled Nitric Oxide in Patients With Chronic Obstructive Pulmonary Disease

Mindful-Breath for People With COPD

The HELlenic Thoracic Society Initiative for CΟPD and CVD

Magnetic Stimulation of Diaphragm in Chronic Obstructive Pulmonary Disease

COPD Exacerbation Modelling Using Unobtrusive Sensors - the TOLIFE Clinical Study A