Efficacy and Safety Study of Two Fixed-dose Combinations of Aclidinium Bromide With Formoterol Fumarate Compared With Aclidinium Bromide, Formoterol Fumarate and Placebo (LAC-MD-27)

This study has been completed.
Sponsor:
Collaborator:
Almirall, S.A.
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT01049360
First received: January 13, 2010
Last updated: September 30, 2011
Last verified: September 2011
  Purpose

The purpose of this study is to evaluate the efficacy of this multicenter, randomized, double-blind, placebo-controlled, 4-period, incomplete-block crossover, dose-ranging study comparing 2 fixed dose combinations (FDCs) of aclidinium bromide with formoterol fumarate or with placebo, aclidinium bromide and formoterol fumarate, all administered twice a day (BID) in patients with stable, moderate to severe chronic obstructive pulmonary disease (COPD) beginning with a 2-week run-in period and with a 7-10 day washout each between treatment period.


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
Drug: aclidinium bromide/formoterol fumarate combination
Drug: aclidinium bromide
Drug: formoterol fumarate
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety Study of Two Fixed-Dose Combinations of Aclidinium Bromide With Formoterol Fumarate Compared With Aclidinium Bromide, Formoterol Fumarate, and Placebo All Administered Twice Daily (BID) to Patients With Stable, Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

Resource links provided by NLM:


Further study details as provided by Forest Laboratories:

Primary Outcome Measures:
  • The primary efficacy assessment will be the change from baseline in normalized forced expiratory volume in 1 second (FEV1). [ Time Frame: 14 day time frame per treatment period ] [ Designated as safety issue: No ]
  • AUC0-12 measured over the 12 hours after morning dose of Investigational Product(IP) at Day 14 on treatment. [ Time Frame: 14 day time frame per treatment period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The secondary efficacy assessments will be the change from baseline in morning predose FEV1 and the change from baseline in morning peak FEV1, both at Day 14 on treatment. [ Time Frame: 14 day time frame per treatment period ] [ Designated as safety issue: No ]

Enrollment: 128
Study Start Date: December 2009
Study Completion Date: September 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
1) Aclidinium bromide with Formoterol fumarate
Drug: aclidinium bromide/formoterol fumarate combination
Aclidinium bromide with 2 dose levels of Formoterol fumarate compared with placebo, aclidinium bromide and formoterol fumarate delivered by inhalation twice daily for a 14 day period within four different treatment periods.
Experimental: 2
2) Aclidinium bromide with Formoterol fumarate
Drug: aclidinium bromide/formoterol fumarate combination
Aclidinium bromide with 2 dose levels of Formoterol fumarate compared with placebo, aclidinium bromide and formoterol fumarate delivered by inhalation wice daily for a 14 day period within four different treatment periods.
Experimental: 3
3) Aclidinium bromide
Drug: aclidinium bromide
Aclidinium bromide with 2 dose levels of Formoterol fumarate compared with placebo, aclidinium bromide and formoterol fumarate delivered by inhalation twice daily for a 14 day period within four different treatment periods.
Active Comparator: 4
4) Formoterol fumarate
Drug: formoterol fumarate
Aclidinium bromide with 2 dose levels of Formoterol fumarate compared with placebo, aclidinium bromide and formoterol fumarate delivered twice daily for a 14 day period within four different treatment periods.
Placebo Comparator: 5
5) Placebo
Drug: placebo
Aclidinium bromide with 2 dose levels of Formoterol fumarate compared with placebo, aclidinium bromide and formoterol fumarate delivered by inhalation twice daily for a 14 day period within four different treatment periods.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Understand the study procedures and be willing to participate in the study as indicated by signing the ICF and HIPAA form
  • Be male or female aged 40 to 80 years, inclusive
  • Have a diagnosis of stable, moderate to severe COPD (stages II and III) as defined by guidelines of the Global Initiative for Chronic Obstructive Lung Disease (2008)
  • Be a current or former cigarette smoker with a smoking history of at least 10 pack-years
  • Have post-albuterol/salbutamol FEV1 values ≥ 30% and < 80% of the predicted value. FEV1 will be measured at the Screening Visit (Visit 1) between 10 and 15 minutes after inhalation of albuterol/salbutamol.
  • Have post-albuterol/salbutamol FEV1/FVC values < 70% (ie, 100 × post- albuterol/salbutamol FEV1/FVC < 70%).
  • If female, be at least 1 year postmenopausal or surgically sterile (defined as having a hysterectomy or tubal ligation). Women of childbearing potential must have a negative serum β-human chorionic gonadotropin pregnancy test at screening
  • Be in good stable health (as judged by the Investigator) other than the COPD, based on medical history, physical examination, ECG, spirometry, and clinical laboratory data evaluations
  • Have COPD symptoms and FEV1 values at the time of randomization that are stable compared with those at Screening (Visit 1), according to the Investigator's medical judgment

Exclusion Criteria:

  • Have been hospitalized for an acute COPD exacerbation within 3 months before screening
  • Have any respiratory tract infection (including the upper respiratory tract) or signs of a COPD exacerbation or respiratory infection in the 6 weeks before Screening (Visit 1).
  • Have any clinically significant respiratory conditions other than COPD
  • Have a history or presence of asthma verified from medical records
  • Have used theophylline (including long-acting theophylline) within the previous 3 months before study entry
  • Have Stage II hypertension, defined as systolic pressure of 160 and above, and diastolic pressure of 100 and above
  • Chronic use of oxygen therapy ≥ 15 hours a day
  • Have a history, current diagnosis, or presence of exercise-induced bronchospasm
  • Have a body mass index ≥ 40 kg/m2
  • Have participated in an pulmonary rehabilitation program within the previous 3 months
  • Have clinically significant cardiovascular conditions
  • Have uncontrolled infection resulting from human immunodeficiency virus and/or active hepatitis
  • Have symptomatic prostatic hypertrophy and/or bladder neck obstruction.
  • Have narrow-angle glaucoma
  • Have a history of hypersensitivity reaction (including report of paradoxical bronchospasm) to inhaled anticholinergics (including aclidinium bromide), β2 adrenergic agonists, or any other inhaled medication or any component thereof
  • Have a QTcB, as indicated in the centralized reading report, above 470 msec in the resting ECGs performed at Screening (Visit 1) and/or patients who are using medications that may prolong the QT interval
  • Have clinically relevant abnormalities in the results of clinical laboratory tests, in ECG parameters other than QTc, in results of the physical examination,
  • Have any concurrent medical condition that, in the judgment of the Investigator, might interfere with the conduct of the study, confound the interpretation of the study results, or endanger the patient's well-being
  • Do not maintain regular day/night, waking/sleeping cycles (eg, patients with history of sleep apnea syndrome or any disease related with sleep disturbances such as restless legs syndrome or somnambulism)
  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: NCT01049360

Locations
United States, Arizona
Forest Investigative Site 0909
Glendale, Arizona, United States, 85306
Forest Investigative Site 2050
Pheonix, Arizona, United States, 85006
United States, California
Forest Investigative Site 2029
Rancho Mirage, California, United States, 92270
Forest Investigative Site 1084
Stockton, California, United States, 95207
United States, Colorado
Forest Investigative Site 2045
Wheat Ridge, Colorado, United States, 80033
United States, Florida
Forest Investigative Site 1152
Clearwater, Florida, United States, 33765
Forest Investigative Site 2047
Tampa, Florida, United States, 33613
Forest Investigative Site 2053
Tampa, Florida, United States, 33603
United States, Massachusetts
Forest Investigative Site 1431
N. Dartmouth, Massachusetts, United States, 02747
United States, New Jersey
Forest Investigative Site 2084
Summit, New Jersey, United States, 07901
United States, New York
Forest Investigative Site 1119
Elmira, New York, United States, 14901
United States, North Carolina
Forest Investigative Site 2035
Elizabeth city, North Carolina, United States, 27909
Forest Investigative Site 1153
Raleigh, North Carolina, United States, 27607
United States, Ohio
Forest Investigative Site 2028
Cincinnati, Ohio, United States, 45242
United States, Oregon
Forest Investigative Site 2043
Medford, Oregon, United States, 97504
Forest Investigative Site 1106
Portland, Oregon, United States, 97213
United States, Rhode Island
Forest Investigative Site 1089
E. Providence, Rhode Island, United States, 02914
United States, South Carolina
Forest Investigative Site 1121
Spartanburg, South Carolina, United States, 29303
United States, Texas
Forest Investigative Site 1498
San Antonio, Texas, United States, 78215
Forest Investigative Site 1129
Waco, Texas, United States, 76712
Sponsors and Collaborators
Forest Laboratories
Almirall, S.A.
Investigators
Study Director: Paul Rowe, MD Forest Laboratories
  More Information

No publications provided

Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT01049360     History of Changes
Other Study ID Numbers: LAC-MD-27
Study First Received: January 13, 2010
Last Updated: September 30, 2011
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on September 30, 2014