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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
History of Changes
  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:

U.S. FDA Resources

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

  Show 137 Study Locations
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 May 22, 2013