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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:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Almirall, S.A.
ClinicalTrials.gov Identifier:
NCT01001494
First received: October 22, 2009
Last updated: August 14, 2012
Last verified: August 2012
History of Changes
  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
 Drug: Aclidinium bromide 200 μg bid
Drug: Aclidinium bromide 400 μg bid
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

U.S. FDA Resources

Further study details as provided by Almirall, S.A.:

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: week 24 ] [ Designated as safety issue: No ]
  • Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in the First Second (FEV1) at Week 12 on Treatment [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change From Baseline in Peak Forced Expiratory Volume in the First Second (FEV1) at Week 24 on Treatment [ Time Frame: week 24 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    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 Achievd at Least a 4-unit Decrease From Baseline in the SGRQ Total Score at Week 24 on Treatment [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    Number of patients who achievd 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
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01001494

  Show 106 Study Locations
Sponsors and Collaborators
Almirall, S.A.
Forest Laboratories
Investigators
Study Director: Estrella Garcia, Ph.D. Almirall, S.A.
  More Information

Additional Information:
Almirall Corporate Website  This link exits the ClinicalTrials.gov site

No publications provided by Almirall, S.A.

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

Responsible Party: Almirall, S.A.
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: August 14, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Almirall, S.A.:
Chronic Obstructive Pulmonary Disease
antimuscarinic
COPD

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
 Bromides
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013