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To Evaluate the Long-term Safety of (R,R)-Formoterol in Subjects With COPD

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sunovion
ClinicalTrials.gov Identifier:
NCT00064415
First received: July 8, 2003
Last updated: February 21, 2012
Last verified: February 2012
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Sunovion:

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
Experimental: 1
Arformoterol tartrate 50 mcg QD
Drug: arformoterol
Arformoterol inhalation solution, 50 mcg QD
Other Names:
  • Brovana Inhalation Solution
  • (R,R)-Formoterol
Active Comparator: 2
Salmeterol 42 mcg BID
Drug: Salmeterol
Salmeterol MDI, 42 mcg BID
Other Names:
  • Serevent MDI
  • racemic formoterol

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. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.

  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
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: NCT00064415

  Show 90 Study Locations
Sponsors and Collaborators
Sunovion
  More Information

No publications provided

Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT00064415     History of Changes
Other Study ID Numbers: 091-060
Study First Received: July 8, 2003
Last Updated: February 21, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 20, 2014