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Efficacy and Safety of LAS 34273 in Patients With Moderate to Severe Stable Chronic Obstructive Pulmonary Disease(COPD)

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.
 
ClinicalTrials.gov Identifier: NCT00358436
Recruitment Status : Completed
First Posted : July 31, 2006
Results First Posted : November 1, 2012
Last Update Posted : January 4, 2017
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease (COPD) Drug: Aclidinium bromide Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 804 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : August 2006
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Aclidinium 200 μg once-daily
Aclidinium bromide 200 μg once-daily by inhalation
 Drug: Aclidinium bromide
Aclidinium bromide 200 μg once-daily via inhalation by the Eklira Genuair® inhaler: 1 puff in the morning for 52 weeks
Placebo Comparator: Placebo
Placebo by inhalation
 Drug: Placebo
Placebo once-daily via inhalation: 1 puff in the morning for 52 weeks


Outcome Measures
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Primary Outcome Measures :
  1. Trough FEV1 (L) at 28 Weeks on Treatment [ Time Frame: 28 weeks ]
    Trough FEV1 (mean FEV1 value of the two highest FEV1 readings measured at 23 and 24 hours after inhalation) at 28 weeks

  2. Trough FEV1 (L) at 12 Weeks on Treatment [ Time Frame: 12 weeks ]
    Trough FEV1 (mean FEV1 value of the two highest FEV1 readings measured at 23 and 24 hours after inhalation) at 12 weeks


Secondary Outcome Measures :
  1. Time to First Moderate or Severe COPD Exacerbation at 52 Weeks on Treatment [ Time Frame: 52 weeks ]
    Time to first moderate or severe exacerbation: Increase of COPD symptoms during at least 2 consecutive days, treated with antibiotics and/or systemic corticosteroids or an increase in dose of systemic corticosteroids, or leading to hospitalisation.

  2. Percentage of Patients Who Achieved at Least a 4-unit Decrease From Baseline in the SGRQ Total Score at 52 Weeks on Treatment [ Time Frame: 52 weeks ]
    Percentage of patients who achieved a clinically relevant improvement in health-related quality of life at 52 weeks, as measured by at least a 4-unit decrease from baseline in St George's Respiratory Questionnaire (SGRQ) total score


Eligibility Criteria
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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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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): NCT00358436


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00358436    
Other Study ID Numbers: M/34273/31
ACCLAIM II ( Other Identifier: Almirall,S.A. )
CT000742 ( Other Identifier: Almirall,S.A. )
First Posted: July 31, 2006    Key Record Dates
Results First Posted: November 1, 2012
Last Update Posted: January 4, 2017
Last Verified: November 2016
Keywords provided by AstraZeneca:
COPD
Lung function
Exacerbations
Quality of Life
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
 Respiratory Tract Diseases
Bromides
Anticonvulsants