A Pivotal Study of the Safety and Effectiveness of Arformoterol in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Information source: Sepracor, Inc.
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: COPD
Intervention: Arformoterol tartrate inhalation solution (Drug); Arformoterol tartrate inhalation solution (Drug); Arformoterol tartrate inhalation solution (Drug); Salmeterol MDI (Drug); Placebo (Drug)
Phase: Phase 3
Sponsored by: Sepracor, Inc.
A 12 week study to investigate the safety and effectiveness of arformoterol given twice daily
compared to placebo in subjects with COPD.
Official title: A Double-Blind, Double-Dummy, Randomized, Placebo- and Active-Controlled, Multicenter, Parallel-Group Study of (R,R)-Formoterol in the Treatment of Subjects With Chronic Obstructive Pulmonary Disease
Study design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
Primary outcome: Percent change from study baseline FEV1 to the end of the dosing interval (12 hours post-second dose for the BID treatment arms and 24 hours post-dose for the QD treatment arm)
Time-normalized area under the percent change from visit pre-dose curve for FEV1 over 12 hours (nAUC0-12)
Peak percent of predicted FEV1
Time-normalized area under the percent change from study baseline curve for FEV1 over 12 hours (nAUC0-12)
Time-normalized area under the percent change from study baseline curve for FEV1 over 24 hours (nAUC0-24)
Timepoint changes in FEV1
Time to onset of response
Time to peak change in FEV1
At-home and in-clinic peak expiratory flow rate (PEFR)
Ipratropium bromide MDI use
Racemic albuterol MDI use
Exacerbations of COPD
COPD symptom ratings (over 12 weeks of treatment)
Relationship between plasma concentrations of (R,R) formoterol and selected pharmacodynamic parameters
This study is a double-blind, double-dummy, randomized, placebo- and active-controlled,
multicenter, parallel-group study of adult subjects with a primary clinical diagnosis of
COPD. Approximately 800 subjects were to be randomized in this study. Study participation
consisted of a total of eight (8) study visits over approximately four (4) months for each
Minimum age: 35 Years.
Maximum age: N/A.
- Subject may be male or female and must be aged less than or equal to 35 years on the
day the informed consent is signed.
- Female subjects greater than or equal to 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 (defined as status post-hysterectomy or bilateral
tubal ligation) OR
- Subject must have a primary diagnosis of COPD, which may include components of chronic
bronchitis and/or emphysema. Diagnosis can be made during the screening process.
- Subject must have a minimum smoking history of 15 pack-years (pack-years = the number
of cigarette packs per day times the number of years).
- Subject must have a chest x-ray that is consistent with the diagnosis of COPD (e. g.,
not diagnostic of pneumonia, other infection, atelectasis, or pneumothorax or other
active/ongoing pulmonary conditions) and taken less than or equal to 3 months prior to
study start. If there is no chest x-ray taken less than or equal to 3 months prior to
study start, or if recent results are unavailable for review, a chest x-ray will be
- Subject must be able to complete all study questionnaires and logs reliably. Exclusion
- Female subject who is pregnant or lactating.
- Subject who has 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.
- 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 study start.
- Subject with a known history of asthma or any chronic respiratory disease (including a
current history of sleep apnea) other than COPD (chronic bronchitis and/or
- Subject with a history of cancer except non-melanomatous skin cancer. Subjects with a
history of cancer that is considered surgically cured and without a recurrence within
the past 10 years may participate in the study. History of hematologic/lymphatic
malignancy treated with chemotherapy or radiation is not allowed.
- Subject with a history of lung resection of more than one full lobe.
- Subject who requires continuous supplemental oxygen therapy (unless subject resides at
elevation greater than or equal to 4,000 feet).
- Subject who has had a change in dose or type of any medications for COPD within 14
days prior to the screening visit.
- Subject with a known sensitivity to (R,R)-formoterol, ipratropium, salmeterol or
albuterol or any of the excipients contained in any of these formulations.
- Subject with a history of substance abuse or drug abuse within 12 months of study
start, or with a positive urine drug screen at study start.
- Subject using any prescription drug for which concomitant beta-agonist administration
is contraindicated (e. g., beta-blockers).
Locations and Contacts
Mobile, Alabama, United States
Oxford, Alabama, United States
Birmingham, Alabama, United States
Anniston, Alabama, United States
Jasper, Alabama, United States
Little Rock, Arkansas, United States
San Diego, California, United States
Los Angeles, California, United States
Santa Ana, California, United States
Mission Hills, California, United States
Mirage, California, United States
Signal Hill, California, United States
Wheat Ridge, Colorado, United States
Colorado Springs, Colorado, United States
Denver, Colorado, United States
Pensacola, Florida, United States
Miami, Florida, United States
Tampa, Florida, United States
Clearwater, Florida, United States
DeLand, Florida, United States
St. Petersburg, Florida, United States
Ocala, Florida, United States
Atlanta, Georgia, United States
Decatur, Georgia, United States
Austell, Georgia, United States
Bloomington, Illinois, United States
Evansville, Indiana, United States
Shawnee Mission, Kansas, United States
Minneapolis, Minnesota, United States
Charles, Missouri, United States
Las Vegas, Nevada, United States
Margate, New Jersey, United States
South Bound Brook, New Jersey, United States
Alburquerque, New Mexico, United States
Endwell, New York, United States
New York, New York, United States
Ithaca, New York, United States
Spartanburg, North Carolina, United States
Wilmington, North Carolina, United States
Raleigh, North Carolina, United States
Charlotte, North Carolina, United States
Cincinnati, Ohio, United States
Tulsa, Oklahoma, United States
Medford, Oregon, United States
Pittsburg, Pennsylvania, United States
Charleston, South Carolina, United States
Irving, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Richmond, Virginia, United States
Chesapeake, Virginia, United States
Tacoma, Washington, United States
Starting date: February 2002
Ending date: June 2003
Last updated: June 5, 2008