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Efficacy and Safety of Aclidinium Bromide for Treatment of Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (LAS-MD-33)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00891462
First Posted: May 1, 2009
Last Update Posted: January 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AstraZeneca
  Purpose
The purpose of this study is to assess the efficacy (effectiveness) and safety of aclidinium bromide doses as compared to placebo in the treatment of moderate to severe chronic obstructive pulmonary disease. The study will be 16 weeks in duration; 2-week run-in period, 12-week double-blind treatment, and 2-week follow-up phone visit.

Condition Intervention Phase
Chronic Obstructive Pulmonary Disease Drug: Aclidinium bromide Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Aclidinium Bromide at Two Dose Levels (200 μg Twice Daily, 400 μg Twice Daily) vs. Placebo When Administered to Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Change From Baseline in Morning Pre-dose Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: Change from Baseline to 12 weeks ]
    Change from baseline in trough forced expiratory volume in 1 second before the morning dose of aclidinium bromide, Last Observation Carried Forward (LOCF)


Secondary Outcome Measures:
  • Change From Baseline in Peak Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: Change from Baseline to 12 weeks ]
    Change From Baseline in Peak FEV1 (L) at Week 12, Last Observation Carried Forward (LOCF)


Enrollment: 561
Study Start Date: April 2009
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Aclidinium bromide dose, inhaled, for 12 weeks of treatment
Drug: Aclidinium bromide
Aclidinium bromide 200 μg, oral inhalation twice per day for 12 weeks of treatment
Experimental: 2
Aclidinium bromide dose, inhaled, for 12 weeks of treatment
Drug: Aclidinium bromide
Aclidinium bromide 400 μg, oral inhalation twice per day for 12 weeks of treatment
Placebo Comparator: 3
Inhaled placebo for 12 weeks
Drug: Placebo
Dose-matched placebo, oral inhalation twice per day for 12 weeks of treatment

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A diagnosis of stable moderate to severe COPD as defined by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines, 2009; postbronchodilator FEV1/FVC < 70%, and postbronchodilator FEV1 ≥ 30% and < 80% predicted
  • Current or former cigarette smokers

Exclusion Criteria:

  • Patients who have been hospitalized for an acute COPD exacerbation within 3 months before the first visit
  • Respiratory tract infection or COPD exacerbation in the 6 weeks before Visit 1
  • Patient with any clinically significant respiratory conditions other than COPD, cardiovascular conditions or mental illness
  • History or presence of asthma verified from medical records
  • Chronic use of oxygen therapy greater than or equal to 15 hours per day
  • Patient with uncontrolled infection due to HIV and/or active hepatitis
  • Patients with a history of hypersensitivity reaction to inhaled anticholinergics
  • Patients with clinically significant cardiovascular conditions, including myocardial infarction during the previous 6 months, newly diagnosed arrhythmia within the previous 3 months, unstable angina, unstable arrhythmia that had required changes in pharmacological therapy or other intervention.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00891462


  Show 112 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Esther Garcia, MD AstraZeneca
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00891462     History of Changes
Other Study ID Numbers: LAS-MD-33
ACCORD COPD I
First Submitted: April 30, 2009
First Posted: May 1, 2009
Results First Submitted: August 14, 2012
Results First Posted: September 13, 2012
Last Update Posted: January 6, 2017
Last Verified: November 2016

Keywords provided by AstraZeneca:
COPD
Chronic Obstructive Pulmonary Disease
Chronic Bronchitis
Emphysema
Airflow Obstruction, Chronic
Chronic Airflow Obstruction
Chronic Obstructive Airway Disease
Chronic Obstructive Lung Disease

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Bromides
Anticonvulsants