Clinical Trial to Assess Rate of Onset of Bronchodilator Action in Severe Stable Chronic Obstructive Pulmonary Disease (COPD) Patients

This study has been completed.

Sponsors and Collaborators:	Laboratorios Almirall, S.A. Forest Laboratories
Information provided by:	Laboratorios Almirall, S.A.
ClinicalTrials.gov Identifier:	NCT00435760

Purpose

This trial evaluates the rate of onset of bronchodilator action of aclidinium compared to placebo and tiotropium in patients with severe COPD after a single dose treatment.

Condition	Intervention	Phase
COPD	Drug: Aclidinium bromide	Phase III

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study

Further study details as provided by Laboratorios Almirall, S.A.:

Study Start Date:	February 2007
Primary Completion Date:	August 2007 (Final data collection date for primary outcome measure)

Detailed Description:

This is a single dose, randomised, double-blind, double-dummy, 3 period cross-over, placebo controlled, multinational, multicentre trial.

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Males and females aged ≥ 40 years
Current or ex-smokers of ≥ 10 pack-year
Clinical diagnosis of severe stable COPD

Exclusion Criteria:

History or current diagnosis of asthma, allergic rhinitis, or atopy
Respiratory tract infection or acute COPD exacerbation in the last 6 weeks
Hospitalised for an acute COPD exacerbation in the last 3 months
Evidence of contraindicated use of anticholinergic drugs

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00435760

Locations

United Kingdom
Respiratory Clinical Trials Ltd
London, United Kingdom, W1G 8HU

Sponsors and Collaborators

Laboratorios Almirall, S.A.

Forest Laboratories

Investigators

Study Director:

Almirall R&D

Laboratorios Almirall, S.A.

More Information

Sponsor web site This link exits the ClinicalTrials.gov site

Co-Sponsor web site This link exits the ClinicalTrials.gov site

Study ID Numbers:	CT000860
Study First Received:	February 14, 2007
Last Updated:	October 14, 2008
ClinicalTrials.gov Identifier:	NCT00435760
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Laboratorios Almirall, S.A.:

COPD

Study placed in the following topic categories:

Lung Diseases, Obstructive
Respiratory Tract Diseases
Bromides
Lung Diseases
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on January 13, 2009