A Dose Ranging Study of Arformoterol Given Once Daily Compared to Arformoterol Given Twice Daily 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); Placebo (Drug); Arformoterol tartrate inhalation solution (Drug); Arformoterol tartrate inhalation solution (Drug); Arformoterol tartrate inhalation solution (Drug); Placebo (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Sunovion
Summary
A dose ranging study to evaluate the safety, tolerability and efficacy of arformoterol
(given once or twice a day) in subjects with COPD.
Clinical Details
Official title: A Double-blind, Randomized, Multicenter, Two-part Parallel-group, Dose-ranging Study of Twice-daily and Once-daily (R,R) Formoterol in the Treatment of Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Part A: The primary efficacy endpoint is the time-normalized area under the FEV1 percent change from pre-dose curve over 12 hours (nAUC0-12) after the first (AM) dose at the 24 hour clinic visit (Visit 4) following 14 days of double-blind treatment.Part B: The primary efficacy endpoint is the time-normalized area under the FEV1 percent change from pre-dose curve over 24 hours (nAUC0-24) at the 24 hour clinic visit (Visit 7) following 14 days of double-blind treatment.
Secondary outcome: Relationship between plasma concentrations of arformoterol and changes in ECG QTc intervals at steady state throughout the dosing interval.Part A only: Time-normalized area under the curve for FEV1 percent change from pre-dose over 24 hours (nAUC0-24) for each 24 hour clinic visit. Part B only: Time-normalized area under curve for the FEV1 percent change from pre-dose over 12 hours (nAUC0-12) for each 24 hour clinic visit. Time-normalized area under the curve for the percent change in FEV1 from pre-dose over 6 hours (nAUC0-6) for the 6 hour clinic visit (Visits 3 and 6). Percent change in FEV1 from pre-dose to each post dose time point Peak percent change in FEV1 post-dose Ipratropium bromide metered-dose inhaler (MDI) use and racemic albuterol MDI use Morning and evening peak expiratory flow rate (PEFR) Exacerbations of COPD COPD symptom ratings Effects of withdrawal from therapy Relationship between plasma concentrations of (R,R)-formoterol and selected pharmacodynamic parameters. FEV1 percent change from pre-dose (24-hour trough) following 14 days of double-blind treatment.
Detailed description:
This study is a double-blind, repeat-dose, randomized, multicenter, two-part,
parallel-group, dose-ranging study of arformoterol and placebo in the treatment of subjects
with COPD. Approximately 215 subjects will be randomized in this study. Study
participation will consist of a total of eight (8) study visits over approximately ten (10)
weeks 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.
Eligibility
Minimum age: 35 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Subject may be male or female and must be aged greater than or equal to 35 years on
the day the informed consent is signed.
- Female subject less than or equal to 65 years of age must have a serum pregnancy test
conducted at study start and confirmed negative. Subjects of childbearing potential
must be using an acceptable method of birth control and agree to continue its use
throughout the study.
- In order to be considered not of childbearing potential female subjects 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) and taken
less than or equal to 6 months before study start. If there is no chest x-ray taken
less than or equal to 6 months before study start, a chest x-ray will be performed at
Visit 1.
- Subject must be able to complete all study questionnaires and logs reliably.
Exclusion Criteria:
- A female 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's schedule or travel prevents the completion of all required visits.
- Subject is scheduled for in-patient hospitalization, including elective surgery (in
patient or out-patient) during the trial.
- Subject has had a life-threatening/unstable respiratory status, including upper or
lower respiratory tract infection, within the 30 days prior to study start.
- Subject has a known history of asthma (except childhood asthma) or any chronic
respiratory disease (including a current history of sleep apnea) other than COPD
(chronic bronchitis and/or emphysema).
- Subject has a known history of alpha 1 antitrypsin deficiency-related emphysema.
- Subject has a history of cancer except non-melanoma skin cancer. Subjects with a
history of cancer that is considered surgically cured and without a recurrence within
the past 5 years may participate in the study. History of hematologic/lymphatic
malignancy treated with chemotherapy or radiation is not allowed, under any
condition.
- Subject has a history of lung resection of more than one full lobe or being a
recipient of a lung or major organ transplant.
- Subject requires continuous supplemental oxygen therapy (unless subject resides at
elevation greater than or equal to 4,000 feet).
- Subject has had a change in dose or type of any medications for COPD within 14 days
before the screening visit.
- Subject has a known sensitivity to arformoterol, ipratropium or albuterol or any of
the excipients contained in any of these formulations.
- Subject has a history of substance abuse within 12 months of Visit 1, or with a
positive urine drug screen at study start.
- Subject is using any prescription drug for which concomitant beta-agonist
administration is contraindicated (e. g., beta-blockers).
- Subject has had significant blood loss (>500 cc) or donated blood within 60 days
preceding screening or plans to donate blood during or within 60 days after
completing the study.
Locations and Contacts
Encinitas, California, United States
Long Beach, California, United States
Brandon, Florida, United States
Cleawater, Florida, United States
Fort Lauderdale, Florida, United States
Jacksonville, Florida, United States
Port Orange, Florida, United States
West Palm Beach, Florida, United States
Austell, Georgia, United States
Topeka, Kansas, United States
Marrero, Louisiana, United States
New Orleans, Louisiana, United States
Opelousas, Louisiana, United States
McCook, Nebraska, United States
Princeton, New Jersey, United States
Hickory, North Carolina, United States
Statesville, North Carolina, United States
Winston-Salem, North Carolina, United States
Columbus, Ohio, United States
Eugene, Oregon, United States
Medford, Oregon, United States
Pittsburg, Pennsylvania, United States
Charleston, South Carolina, United States
Columbia, South Carolina, United States
Simpsonville, South Carolina, United States
Spartanburg, South Carolina, United States
Austin, Texas, United States
San Antonio, Texas, United States
Renton, Washington, United States
Spokane, Washington, United States
Tacoma, Washington, United States
Additional Information
Starting date: October 2003
Last updated: February 21, 2012
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