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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01001494
First received: October 22, 2009
Last updated: November 16, 2016
Last verified: October 2016
  Purpose
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 Intervention Phase
Chronic Obstructive Pulmonary Disease (COPD)
Drug: Aclidinium bromide 200 μg bid
Drug: Aclidinium bromide 400 μg bid
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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)

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ]
  • 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:
  • Change From Baseline in Peak Forced Expiratory Volume in the First Second (FEV1) at Week 24 on Treatment [ Time Frame: Baseline and Week 24 ]
  • 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

  • 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


Enrollment: 828
Study Start Date: October 2009
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   40 Years and older   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01001494

  Show 106 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: NCT01001494     History of Changes
Other Study ID Numbers: M/34273/34
ATTAIN
Study First Received: October 22, 2009
Results First Received: August 14, 2012
Last Updated: November 16, 2016

Keywords provided by AstraZeneca:
Chronic Obstructive Pulmonary Disease
antimuscarinic
COPD

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

ClinicalTrials.gov processed this record on April 21, 2017