Overview

Determine the Safety and Efficacy of (R,R)-Formoterol in the Treatment of Subjects With COPD

Status:
Completed
Trial end date:
2004-03-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to assess the bronchodilator effect and safety of multiple daily doses of arformoterol administered for 12 weeks as maintenance treatment in patients with COPD
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Sunovion
Treatments:
Formoterol Fumarate
Pharmaceutical Solutions
Salmeterol Xinafoate
Criteria
Inclusion Criteria:

- Be willing to comply with study procedures and visit schedule

- Are at least 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:
documented surgically sterile, OR postmenopausal.

- Have a primary diagnosis of COPD. 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).

- Have a chest x-ray that is consistent with the diagnosis of COPD and taken <3 months
prior to study start

- Able to complete all study questionnaires and logs reliably

Exclusion Criteria:

- Female subject who is pregnant or lactating

- Have participated in an investigational drug study within 30 days prior to study
start, or who is currently participating in another investigational drug study

- Subject whose schedule or travel prevents the completion of all required visits

- Are scheduled for in-patient hospitalization, including elective surgery during the
trial

- Have life-threatening/unstable respiratory status, including upper or lower
respiratory tract infection, within the previous 30 days

- History of asthma or any chronic respiratory disease other than COPD (chronic
bronchitis and/or emphysema)

- Have clinically significant cardiac, hepatic, renal, gastrointestinal, endocrine,
metabolic, neurologic, or psychiatric disorder that may interfere with successful
completion of this protocol

- Have a history of cancer except non-melanomatous skin cancer

- Have a history of lung resection of more than one full lobe

- Requires continuous supplemental oxygen therapy.

- Has 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 arformoterol, ipratropium, salmeterol or albuterol or any
of the excipients contained in any of these formulations

- Have a history of substance abuse or drug abuse within 12 months, or with a positive
urine drug screen

- Are using any prescription drug for which concomitant beta-agonist administration is
contraindicated (e.g., beta-blockers)