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

• Status: Completed
• Trial end date: 2004-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sunovion
• Treatments: Formoterol Fumarate; Salmeterol Xinafoate

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