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

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ClinicalTrials.gov Identifier: NCT01001494
Recruitment Status : Completed
First Posted : October 26, 2009
Results First Posted : September 17, 2012
Last Update Posted : January 4, 2017
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease (COPD) Drug: Aclidinium bromide 200 μg bid Drug: Aclidinium bromide 400 μg bid Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 828 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : October 2009
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Arms and Interventions
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Arm Intervention/treatment
Experimental: Aclidinium bromide 200 μg bid
Aclidinium bromide 200 μg twice-daily via inhalation
 Drug: Aclidinium bromide 200 μg bid
Aclidinium bromide 200 μg twice-daily via inhalation by the Eklira Genuair® inhaler: 1 puff in the morning and evening for 24 weeks
Experimental: Aclidininum bromide 400 μg bid
Aclidinium bromide 400 μg twice-daily via inhalation
 Drug: Aclidinium bromide 400 μg bid
Aclidinium bromide 400 μg twice-daily via inhalation by the Eklira Genuair® inhaler: 1 puff in the morning and evening for 24 weeks
Placebo Comparator: Placebo
Placebo
 Drug: Placebo
Placebo twice-daily by inhalation for 24 weeks


Outcome Measures
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Primary Outcome Measures :
  1. Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in the First Second (FEV1) at Week 24 on Treatment [ Time Frame: Baseline and Week 24 ]
  2. Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in the First Second (FEV1) at Week 12 on Treatment [ Time Frame: Baseline and Week 12 ]

Secondary Outcome Measures :
  1. Change From Baseline in Peak Forced Expiratory Volume in the First Second (FEV1) at Week 24 on Treatment [ Time Frame: Baseline and Week 24 ]
  2. Percentage of Patients Who Achieved at Least a 1-unit Decrease From Baseline in TDI Focal Score at Week 24 on Treatment [ Time Frame: Week 24 ]
    Number of patients achieving a clinically meaningful improvement (≥1-unit) in Transition Dyspnoea Index (TDI) focal score at Week 24 on Treatment

  3. Percentage of Patients Who Achieved at Least a 4-unit Decrease From Baseline in the SGRQ Total Score at Week 24 on Treatment [ Time Frame: Week 24 ]
    Number of patients who achieved a clinically meaningful improvement (≥4-units) in Saint George Respiratory Questionnaire (SGRQ) total score at week 24 on treatment


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:

  • 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.
Contacts and Locations
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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): NCT01001494


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: NCT01001494    
Other Study ID Numbers: M/34273/34
ATTAIN
First Posted: October 26, 2009    Key Record Dates
Results First Posted: September 17, 2012
Last Update Posted: January 4, 2017
Last Verified: October 2016
Keywords provided by AstraZeneca:
Chronic Obstructive Pulmonary Disease
antimuscarinic
COPD
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
 Respiratory Tract Diseases
Bromides
Anticonvulsants