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A Trial Assessing LAS34273 in Moderate to Severe Stable Chronic Obstructive Pulmonary Disease (COPD)

This study has been completed.

Sponsors and Collaborators: Laboratorios Almirall, S.A.
Forest Laboratories
Information provided by: Laboratorios Almirall, S.A.
ClinicalTrials.gov Identifier: NCT00363896
  Purpose

To evaluate the efficacy and safety of LAS 34273 compared to placebo in patients with moderate to severe COPD during one year of treatment.


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
Drug: Aclidinium bromide
Phase III

MedlinePlus related topics:   COPD (Chronic Obstructive Pulmonary Disease)   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Randomized, Double-Blind, Placebo Control, Parallel Assignment
Official Title:   Clinical Trial Assessing Efficacy and Safety of LAS34273 in Moderate to Severe Stable Chronic Obstructive Pulmonary Disease (COPD) Patients

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

Primary Outcome Measures:
  • Lung function

Secondary Outcome Measures:
  • Exacerbations and Quality of Life

Study Start Date:   August 2006

  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 with a clinical diagnosis of moderate to severe stable COPD

Exclusion Criteria:

  • History or current diagnosis of asthma, recent respiratory tract infection or acute COPD exacerbation, life expectancy of less than 1 year, known symptomatic prostatic hypertrophy, bladder neck obstruction or narrow-angle glaucoma
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00363896

Locations
Belgium
Onze Lieve Vrouw Ziekenhuis    
      Aalst, Belgium, 9300

Sponsors and Collaborators
Laboratorios Almirall, S.A.
Forest Laboratories

Investigators
Study Director:     Almirall R & D     Almirall Prodesfarma    
  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:   CT000740
First Received:   August 10, 2006
Last Updated:   July 10, 2008
ClinicalTrials.gov Identifier:   NCT00363896
Health Authority:   Belgium: Directorate general for the protection of Public health: Medicines

Keywords provided by Laboratorios Almirall, S.A.:
COPD  
Lung function  
Exacerbations  
Quality of Life  

Study placed in the following topic categories:
Lung Diseases, Obstructive
Respiratory Tract Diseases
Bromides
Lung Diseases
Quality of Life
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on October 10, 2008




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