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

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: 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

Tracking Information
First Submitted Date  ICMJE October 22, 2009
First Posted Date  ICMJE October 26, 2009
Results First Submitted Date  ICMJE August 14, 2012
Results First Posted Date  ICMJE September 17, 2012
Last Update Posted Date January 4, 2017
Study Start Date  ICMJE October 2009
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 2, 2015)
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 23, 2009)
Change from baseline in morning pre-dose (through) Forced Expiratory Volume in the first second (FEV1) [ Time Frame: week 12 and 24 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 2, 2015)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: October 23, 2009)
  • Change from baseline in peak FEV1 [ Time Frame: week 12 and 24 ]
  • Number (%) of patients achieving a clinically meaningful improvement (≥1-unit) in Transition Dyspnoea Index (TDI) focal score [ Time Frame: week 24 ]
  • Number (%) of patients achieving a clinically meaningful improvement (≥4-units) in Saint George Respiratory Questionnaire (SGRQ) total score [ Time Frame: week 24 ]
  • Adverse Events, laboratory, Electrocardiogram and vital signs [ Time Frame: week 4, 12 and 24 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Aclidinium Bromide at Two Dose Levels Versus Placebo Administered in Chronic Obstructive Pulmonary Disease (COPD) Patients
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Chronic Obstructive Pulmonary Disease (COPD)
Intervention  ICMJE
  • 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
  • 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
  • Drug: Placebo
    Placebo twice-daily by inhalation for 24 weeks
Study Arms  ICMJE
  • Experimental: Aclidinium bromide 200 μg bid
    Aclidinium bromide 200 μg twice-daily via inhalation
    Intervention: Drug: Aclidinium bromide 200 μg bid
  • Experimental: Aclidininum bromide 400 μg bid
    Aclidinium bromide 400 μg twice-daily via inhalation
    Intervention: Drug: Aclidinium bromide 400 μg bid
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 29, 2012)
828
Original Estimated Enrollment  ICMJE
 (submitted: October 23, 2009)
810
Actual Study Completion Date  ICMJE November 2010
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Czech Republic,   France,   Germany,   Hungary,   Italy,   Peru,   Poland,   Russian Federation,   South Africa,   Spain,   Ukraine
Removed Location Countries Argentina,   Chile,   Mexico,   United Kingdom
 
Administrative Information
NCT Number  ICMJE NCT01001494
Other Study ID Numbers  ICMJE M/34273/34
ATTAIN
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party AstraZeneca
Original Responsible Party Estrella Garcia, Almirall S.A.
Current Study Sponsor  ICMJE AstraZeneca
Original Study Sponsor  ICMJE Almirall, S.A.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Esther Garcia, MD AstraZeneca
PRS Account AstraZeneca
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP