Safety Study of Arformoterol Tartrate Inhalation Solution in Chronic Obstructive Pulmonary Disease (COPD) Subjects

Completed · Phase 3 · Has a placebo group

Conditions studied: Chronic Obstructive Pulmonary Disease

In brief

This is a multi-center study to evaluate the long-term safety of arformoterol 15 mcg twice daily (BID) in the treatment of subjects with moderate-to-severe COPD. Study participation will consist of a total of 6 visits over approximately 1 year.

Key facts

Study ID

NCT00909779

Run by

Sumitomo Pharma America, Inc.

People needed

841

Starts

2009-06-01

Expected to finish

2012-06-01

Last updated by the study team

2013-11-11

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject must give written informed consent, including privacy authorization as well as adherence to concomitant medication withholding periods, prior to participation.
• Females considered not of childbearing potential must be surgically sterile (total hysterectomy, bilateral salpingo oophorectomy, or tubal ligation) or post-menopausal, which is defined as a complete cessation of menstruation for at least 1 year.
• Male and female subjects must be at least 40 years old at the time of consent.
• Subjects must have a pre-established, documented primary clinical diagnosis of non-asthmatic COPD or are referred for diagnosis of non-asthmatic COPD.
• Subjects must have a baseline FEV1 of ≤50% predicted volume at Visits 1 and 2 (pre-dose).
• Subjects must have a FEV1 >0.50 L at either Visit 1 or 2 (pre-dose).
• Subject's respiratory status must be clinically stable.
• Subjects must have a FEV1/forced vital capacity (FVC) ratio of ≤70% at either Visit 1 or 2 (pre-dose).
• Subjects must have had at least 1 COPD exacerbation within the last year (defined as initiation or an increase in the dose of oral steroids or antibiotics for the treatment of COPD).
• Subjects must have a ≥15 pack-year smoking history and a baseline breathlessness severity grade of ≥2 (Modified Medical Research Council [MMRC] Dyspnea Scale Score) at Visit 2.
• Female subjects ≤65 years of age must have a negative serum pregnancy test conducted at Visit 1 prior to randomization. Females of childbearing potential must be using an acceptable method of birth control.
• Subjects' overall health must be sufficiently stable to complete the study requirements based on the screening physical examination (defined as the absence of any clinically relevant abnormalities), medical history, 12-lead ECG, and clinical laboratory values (hematology, serum chemistry and urinalysis), and vital signs (heart rate, respiratory rate, and blood pressure) that have been conducted within 30 days of Visit 2 (randomization). If any of the hematology, chemistry, or urinalysis results are not within the laboratory's reference range, then the subject can be included only if the investigator judges the deviations to be not clinically significant.
• Subjects must have a minimum blood pressure of 105/60 mmHg and a minimum resting pulse of 50 bpm at Screening Visit 1. Subjects who do not meet these criteria at Screening Visit 1 must meet the criteria on the first day of dosing (Day 1) in order to be eligible for the study. Subjects with a medical condition which causes low blood pressure or low heart rate, but, in the opinion of the Principal Investigator or designee the medical condition could resolve, may be rescreened when the condition is resolved.
• Subjects must be willing and able to complete all study questionnaires and logs reliably.
• Subjects must be willing and able to comply with study procedures and visit schedule.
• Subjects must have sufficient understanding of English to complete all questionnaires and logs.

You may not qualify if…

• Female subjects who are pregnant or lactating.
• Subjects with a history of asthma, with the exception of asthma diagnosed in childhood.
• Subjects with a blood eosinophil count >5% of total white blood cell count.
• Subjects with a febrile illness within 3 days before Screening.
• Subjects with a malignant neoplasm other than non melanomatous basal cell skin cancer. Subjects with a history of malignancy who have been cancer free for 5 years or more may be enrolled.
• Subjects who are currently using disallowed medications or will be unable to complete the medication washout periods. Subjects taking a prohibited concurrent medication which requires a washout of >30 days may be rescreened when the washout of the prohibited concurrent medication has been met.
• Subjects with life threatening/unstable respiratory status, including upper or lower respiratory tract infection, within the previous 30 days prior to screening.
• Subjects who have had a change in dose or type of any medications for COPD within 2 weeks prior to the screening visit. Subjects not on a stable dose of COPD medications may be rescreened after being on a stable dose for at least 14 days
• Subjects with a chest x ray taken ≤3 months prior to screening that suggests a diagnosis other than COPD (eg, diagnostic of pneumonia, other infection, atelectasis, or pneumothorax or other active/ongoing pulmonary conditions). If there is no chest x ray taken ≤3 months prior to screening, or if recent results are unavailable for review, a chest x ray must be performed prior to visit 2. Subjects with a medical condition that caused the abnormal finding, but, in the opinion of the Principal Investigator or designee the medical condition could resolve, may be rescreened when the condition is resolved
• Subjects with a positive urine drug test during screening.
• Subjects with a known history of alcohol abuse may be enrolled in the study if the subject's current alcohol use does not exceed more than 3 alcoholic beverages per day.
• Subjects whose schedule or travel prevents the completion of all required visits.
• Subjects who are scheduled for inpatient hospitalization or elective surgery (inpatient or outpatient) during the trial. Subjects may be rescreened when the condition is resolved.
• Subjects have participated in an investigational drug study and/or any COPD interventional trial within 30 days prior to screening or who are currently participating in another investigational drug study or COPD interventional trial.
• Subjects with a history of allergic reaction to the study medication or any components of the study medications.
• Subjects who are study site staff members or relatives of study site staff members directly involved in this study.
• Subjects with clinically significant cardiac, (Functional Class III and IV; Objective Class C and D by New York Heart Association [NYHA] Functional Classification),hepatic, renal, gastrointestinal, endocrine, metabolic, neurologic, or psychiatric disorder that may interfere with successful completion of this protocol.

Where it is running

• Alabama Clinical Therapeutic, LLC — Birmingham, Alabama, United States
• Achieve Clinical Research — Brimingham, Alabama, United States
• Jasper Summit Research, LLC — Jasper, Alabama, United States
• Chest Critical Care Consultants — Anaheim, California, United States
• California Research Medical Group — Fullerton, California, United States
• Integrated Research Group — Riverside, California, United States
• Quality Control Research Inc. — Roseville, California, United States
• Sockolov and Sockolov APC — Sacramento, California, United States
• Centers for Clinical Trials of Sacremento — Sacremento, California, United States
• Institute of HealthCare Assessment, Inc. — San Diego, California, United States
• National Jewish Health — Denver, Colorado, United States
• Southeast Clinical Research — Chiefland, Florida, United States
• Tampa Bay Medical Research Inc. — Clearwater, Florida, United States
• Clinical Research of West Florida, Inc. — Clearwater, Florida, United States
• Avail Clinical Research — DeLand, Florida, United States
• The Lung Clinic, P.A. — Kissimmee, Florida, United States
• DCT — Orlando, Florida, United States
• Clinical Research of West Florida — Tampa, Florida, United States
• Study site — Canton, Georgia, United States
• Southeast Regional Research Group — Columbus, Georgia, United States
• Atlanta Pharmaceutical Research — Decatur, Georgia, United States
• Wellstar Marietta Pulmonary Medicine — Marietta, Georgia, United States
• Southeast Regional Research Group — Rincon, Georgia, United States
• Medisphere Medical Research Center — Evansville, Indiana, United States
• Jefferson Clinic — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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