Safety and Tolerability of Aclidinium Bromide/Formoterol Fumarate Compared With Formoterol Fumarate in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (LAC)

This study has been completed.
Sponsor:
Collaborator:
Almirall, S.A.
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT01437540
First received: September 19, 2011
Last updated: April 5, 2013
Last verified: April 2013
  Purpose

The purpose of this study is to assess the long-term safety and tolerability of inhaled aclidinium bromide/formoterol in patients with moderate to severe, stable chronic obstructive pulmonary disease (COPD).


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
Drug: Aclidinium Bromide/Formoterol Fumarate
Drug: Formoterol Fumarate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Long-Term, Randomized, Study of the Safety and Tolerability of a Fixed-Dose Combination of Aclidinium Bromide/Formoterol Fumarate Compared With Formoterol Fumarate in Patients With Moderate to Severe, Stable Chronic Obstructive Pulmonary Disease (COPD)

Resource links provided by NLM:


Further study details as provided by Forest Laboratories:

Primary Outcome Measures:
  • Adverse event (AE) recording [ Time Frame: From Baseline (Week 0) to Week 52 ] [ Designated as safety issue: Yes ]
    Number of patients to experience a Treatment Emergent Adverse Event (TEAE)

  • Vital Signs [ Time Frame: From Baseline (Week 0) to Week 52 ] [ Designated as safety issue: Yes ]
    Number of patients to experience a potentially clinically significant (PCS) change in pulse rate, systolic and diastolic blood pressure, body temperature or body weight.

  • Electrocardiograms (ECGs) [ Time Frame: From Baseline (Week 0) to Week 52 ] [ Designated as safety issue: Yes ]
    Number of patients to experience potentially clinically significant changes in ECG from Baseline.

  • Clinical Laboratory Measures [ Time Frame: From Baseline (Week 0) to Week 52 ] [ Designated as safety issue: Yes ]
    Number of patients to experience a potentially clinically significant (PCS) change in clinical laboratory values for Hematology, Chemistry, Urinalysis or Theophylline.


Enrollment: 590
Study Start Date: September 2011
Study Completion Date: April 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Aclidinium/formoterol FDC, high dose twice per day
Drug: Aclidinium Bromide/Formoterol Fumarate
Inhaled Aclidinium/formoterol high dose twice per day
Active Comparator: 2
Formoterol 12 μg
Drug: Formoterol Fumarate
Inhaled Formoterol 12 μg, twice per day

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Current or former cigarette smokers with a cigarette smoking history of at least 10 pack-years
  • A diagnosis of stable moderate to severe COPD and stable airway obstruction as defined by the Global Initiative for Chronic Obstructive Lung Disease guidelines and stable airway obstruction.

Exclusion Criteria:

  • Patients who have been hospitalized for an acute COPD exacerbation within three months prior to Visit 1
  • Any respiratory tract infection (including the upper respiratory tract) or COPD exacerbation in the six weeks before Visit 1.
  • Patients with any clinically significant respiratory conditions other than COPD
  • Clinical history that suggests that the patient has asthma as opposed to COPD
  • Chronic use of oxygen therapy ≥ 15 hours/day
  • Patients with clinically significant cardiovascular conditions
  • Patients with uncontrolled infection that may place the patient at risk resulting from human immunodeficiency virus (HIV), active hepatitis and/or patients with diagnosed active tuberculosis
  • Patients with a history of hypersensitivity reaction to inhaled anticholinergics,
  • Patients with Stage II hypertension, defined as systolic pressure of 160 and above, and/or diastolic pressure of 100 and above
  • Current diagnosis of cancer other than basal or squamous cell skin cancer
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01437540

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Locations
United States, Alabama
Forest Investigative Site 1162
Birmingham, Alabama, United States, 35209
Forest Investigative Site 1493
Birmingham, Alabama, United States, 35209
Forest Investigative Site 1620
Birmingham, Alabama, United States, 35235
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Mobile, Alabama, United States, 36608
United States, Arizona
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Chandler, Arizona, United States, 85224
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Peoria, Arizona, United States, 85381
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Phoenix, Arizona, United States, 85020
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Phoenix, Arizona, United States, 85012
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United States, Arkansas
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Fort Smith, Arkansas, United States, 72901
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Encinitas, California, United States, 92024
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Lakewood, California, United States, 90712
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Los Angeles, California, United States, 90048
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Los Angeles, California, United States, 90025
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Torrance, California, United States, 90505
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Walnut Creek, California, United States, 94598
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Colorado Springs, Colorado, United States, 80907
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Fort Collins, Colorado, United States, 80528
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Wheat Ridge, Colorado, United States, 80033
United States, Connecticut
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Norwalk, Connecticut, United States, 06851
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Stamford, Connecticut, United States, 06902
United States, Florida
Forest Investigative Site 1154
Brandon, Florida, United States, 33511
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Debary, Florida, United States, 32713
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Atlanta, Georgia, United States, 30342
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Evansville, Indiana, United States, 47713
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Council Bluffs, Iowa, United States, 51503
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Bowling Green, Kentucky, United States, 42101
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Traverse City, Michigan, United States, 49684
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Forest Investigative Site 1609
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United States, Nevada
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Newburgh, New York, United States, 12550
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Syracuse, New York, United States, 13210
United States, North Carolina
Forest Investigative Site 1557
Raleigh, North Carolina, United States, 27612
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Shelby, North Carolina, United States, 28152
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Wilmington, North Carolina, United States, 28401
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Winston-Salem, North Carolina, United States, 27103
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Canton, Ohio, United States, 44718
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Cincinnati, Ohio, United States, 45242
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Zanesville, Ohio, United States, 43701
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Ashland, Oregon, United States, 97520
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Corvallis, Oregon, United States, 97330
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Portland, Oregon, United States, 97213
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Bethlehem, Pennsylvania, United States, 18020
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Uniontown, Pennsylvania, United States, 15401
United States, Rhode Island
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Johnston, Rhode Island, United States, 02919
United States, South Carolina
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Charleston, South Carolina, United States, 29406
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Easley, South Carolina, United States, 29640
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Greenville, South Carolina, United States, 29615
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Greer, South Carolina, United States, 29651
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Spartanburg, South Carolina, United States, 29303
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Union, South Carolina, United States, 29379
United States, South Dakota
Forest Investigative Site 1365
Rapid City, South Dakota, United States, 57702
United States, Texas
Forest Investigative Site 1440
Arlington, Texas, United States, 76012
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Austin, Texas, United States, 78731
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Dallas, Texas, United States, 75231
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Dallas, Texas, United States, 75231
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El Paso, Texas, United States, 79903
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Fort Worth, Texas, United States, 76104
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Killeen, Texas, United States, 76543
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San Antonio, Texas, United States, 78229
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San Antonio, Texas, United States, 78228
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San Antonio, Texas, United States, 78229
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San Antonio, Texas, United States, 78215
United States, Utah
Forest Investigative Site 1600
Magna, Utah, United States, 84044
United States, Virginia
Forest Investigative Site 1480
Abingdon, Virginia, United States, 24210
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Alexandria, Virginia, United States, 22304
United States, Washington
Forest Investigative Site 1142
Spokane, Washington, United States, 99204
Forest Investigative Site 1573
Spokane, Washington, United States, 99216
Sponsors and Collaborators
Forest Laboratories
Almirall, S.A.
Investigators
Study Director: Thomas Goodin, PhD Forest Laboratories
  More Information

No publications provided

Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT01437540     History of Changes
Other Study ID Numbers: LAC-MD-32
Study First Received: September 19, 2011
Last Updated: April 5, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Forest Laboratories:
COPD
Chronic Obstructive Pulmonary Disease
Chronic Bronchitis
Emphysema
Airflow Obstruction, Chronic
Chronic Airflow Obstruction
Chronic Obstructive Airway Disease
Chronic Obstructive Lung Disease

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Bromides
Formoterol
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on April 15, 2014