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A Pivotal Study of the Safety and Effectiveness of Arformoterol in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

Information source: Sunovion
ClinicalTrials.gov processed this data on August 23, 2015
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

Status: Completed

Sponsored by: Sunovion


A 12 week study to investigate the safety and effectiveness of arformoterol given twice daily compared to placebo in subjects with COPD.

Clinical Details

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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

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)

Secondary outcome:

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

Detailed description: 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 subject. 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.


Minimum age: 35 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria

- 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

- postmenopausal

- 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 performed.

- Subject must be able to complete all study questionnaires and logs reliably.

Exclusion Criteria

- 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 emphysema).

- 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

Anniston, Alabama, United States

Birmingham, Alabama, United States

Jasper, Alabama, United States

Mobile, Alabama, United States

Oxford, Alabama, United States

Little Rock, Arkansas, United States

Los Angeles, California, United States

Mirage, California, United States

Mission Hills, California, United States

San Diego, California, United States

Santa Ana, California, United States

Signal Hill, California, United States

Colorado Springs, Colorado, United States

Denver, Colorado, United States

Wheat Ridge, Colorado, United States

Clearwater, Florida, United States

DeLand, Florida, United States

Miami, Florida, United States

Ocala, Florida, United States

Pensacola, Florida, United States

St. Petersburg, Florida, United States

Tampa, Florida, United States

Atlanta, Georgia, United States

Austell, Georgia, United States

Decatur, 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

Ithaca, New York, United States

New York, New York, United States

Charlotte, North Carolina, United States

Raleigh, North Carolina, United States

Spartanburg, North Carolina, United States

Wilmington, 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

Houston, Texas, United States

Irving, Texas, United States

San Antonio, Texas, United States

Chesapeake, Virginia, United States

Richmond, Virginia, United States

Tacoma, Washington, United States

Additional Information

Starting date: February 2002
Last updated: November 1, 2012

Page last updated: August 23, 2015

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