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To Evaluate the Long-Term Safety of (R,R)-Formoterol in Subjects With COPD
This study has been completed.
Sponsored by: Sepracor, Inc.
Information provided by: Sepracor, Inc.
ClinicalTrials.gov Identifier: NCT00064415
  Purpose

The purpose of this study is to determine the long-term safety of arformoterol over a period of 12 months in subjects with COPD


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
Chronic Bronchitis
Emphysema
Drug: arformoterol
Drug: Salmeterol
Phase III

MedlinePlus related topics: Bronchitis COPD (Chronic Obstructive Pulmonary Disease) Emphysema
Drug Information available for: Formoterol Arformoterol Arformoterol Tartrate Formoterol fumarate Salmeterol Salmeterol xinafoate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study
Official Title: A Multicenter, Open-Label, Randomized, Active-Controlled, Parallel Group Chronic Safety Study of (R,R)-Formoterol in the Treatment of Subjects With Chronic Obstructive Pulmonary Disease

Further study details as provided by Sepracor, Inc.:

Primary Outcome Measures:
  • Overall occurrence of adverse events [ Time Frame: Weeks -1, 0, 3, 6, 9, 13, 26, 39, 52 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Laboratory parameters [ Time Frame: Weeks -1, 0, 3, 6, 9, 13, 26, 39, 52 ] [ Designated as safety issue: Yes ]
  • ECG parameters [ Time Frame: Weeks -1, 0, 3, 6, 9, 13, 26, 39, 52 ] [ Designated as safety issue: Yes ]
  • 24-hour holter monitoring parameters [ Time Frame: Weeks -1, 0, 13, 26, 39, 52 ] [ Designated as safety issue: Yes ]
  • Vital signs [ Time Frame: Weeks -1, 0, 3, 6, 9, 13, 26, 39, 52 ] [ Designated as safety issue: Yes ]
  • Plasma arformoterol concentrations [ Time Frame: Weeks -1, 0, 3, 6, 9, 13, 26, 39, 52 ] [ Designated as safety issue: No ]
  • Physical examination findings [ Time Frame: Weeks -1, 53 ] [ Designated as safety issue: No ]

Enrollment: 799
Study Start Date: June 2002
Study Completion Date: December 2004
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Arformoterol tartrate 50 mcg QD
Drug: arformoterol
Arformoterol inhalation solution, 50 mcg QD
2: Active Comparator
Salmeterol 42 mcg BID
Drug: Salmeterol
Salmeterol MDI, 42 mcg BID

Detailed Description:

This was a multicenter, open-label, randomized, active controlled, parallel group chronic safety study of arformoterol 50 mcg once daily over a period of 12 months in subjects with COPD

  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA: In order to qualify for participation, subjects must meet the following criteria:

  • Must give written informed consent prior to participation. Women of childbearing potential must also sign the Women of Childbearing Potential Addendum.
  • Must be willing to comply with study procedures and visit schedule
  • Male or female >35 years of age
  • Female subjects <65 years of age must have a serum pregnancy test conducted at Visit 1 and confirmed negative prior to randomization. Subjects of childbearing potential must be using an acceptable method of birth control.
  • Female subjects who are considered not of childbearing potential must be: (1) documented surgically sterile, OR (2) postmenopausal
  • Have a primary diagnosis of COPD, which may include components of chronic bronchitis and/or emphysema. Diagnosis can be made during the screening process.
  • Have a minimum smoking history of 15 pack-years (pack-years = the number of cigarette packs per day times the number of years)
  • Medical Research Council (MRC) Dyspnea Scale Score >2
  • Have a baseline FEV1 <65% of predicted normal value and >0.70 L documented prior to randomization
  • Have an FEV1/FVC ratio <70% documented prior to randomization.
  • Have a chest x-ray that is consistent with the diagnosis of COPD and taken <3 months prior to Visit 1. If there is no chest x-ray taken 3 months prior to Visit 1, a chest x-ray will be performed prior to Visit 2.
  • Be able to complete all study questionnaires and logs reliably

EXCLUSION CRITERIA: In order to qualify for participation, subjects must not meet any of the following criteria:

  • Currently using disallowed medications or will be unable to complete the medication washout periods
  • Female subject who is pregnant or lactating
  • Have participated in an investigational drug study within 30 days prior to Visit 1 or who is currently participating in another investigational drug study
  • Subject whose schedule or travel prevents the completion of all required visits
  • Subject who is scheduled for in-patient hospitalization, including elective surgery (in-patient or out-patient) during the trial.
  • Subject with life-threatening/unstable respiratory status, including upper or lower respiratory tract infection, within the previous 30 days prior to Visit 1
  • Known history of asthma or any chronic respiratory disease (including a current history of sleep apnea) other than COPD (chronic bronchitis and/or emphysema).
  • Subject with a blood eosinophil count >5%
  • Subject with clinically significant cardiac, hepatic, renal, gastrointestinal, endocrine, metabolic, neurologic, or psychiatric disorder that may interfere with successful completion of this protocol
  • History of cancer except non-melanomatous skin cancer
  • History of lung resection of more than one full lobe
  • Subject who requires continuous supplemental oxygen therapy. The use of supplemental oxygen, not to exceed 2 L/minute, at nighttime only and/or only during exercise is allowed.
  • Have had a change in dose or type of any medications for COPD within 14 days prior to the screening visit
  • Have a known sensitivity to (R,R)-formoterol, ipratropium, salmeterol or albuterol or any of the excipients contained in any of these formulations
  • Have clinically significant abnormalities that may interfere with the metabolism or excretion of the study drug
  • Have a history of substance abuse or drug abuse within 12 months of Visit 1 or with a positive urine drug screen at the screening visit
  • Subject with clinically significant abnormal laboratory values
  • Subject with clinically significant abnormal 12-lead ECG that may jeopardize the subject's ability to complete the study
  • Subject using any prescription drug for which concomitant beta-agonist administration is contraindicated
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00064415

  Show 90 Study Locations
Sponsors and Collaborators
Sepracor, Inc.
  More Information

Responsible Party: Sepracor ( Arformoterol Medical Director )
Study ID Numbers: 091-060
Study First Received: July 8, 2003
Last Updated: August 12, 2008
ClinicalTrials.gov Identifier: NCT00064415  
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Pulmonary Emphysema
Emphysema
Bronchitis, Chronic
Lung Diseases, Obstructive
Salmeterol
Respiratory Tract Infections
Respiratory Tract Diseases
Lung Diseases
Respiration Disorders
Formoterol
Bronchitis
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:
Respiratory System Agents
Neurotransmitter Agents
Bronchial Diseases
Adrenergic beta-Agonists
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Asthmatic Agents
Adrenergic Agonists
Pharmacologic Actions
Pathologic Processes
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on January 16, 2009