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Study of Arformoterol Tartrate Inhalation Solution and Racemic Formoterol in Subjects With Mild to Moderate Chronic Obstructive Pulmonary Disease (COPD) | Clinical Trials | Clareo Health

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Study of Arformoterol Tartrate Inhalation Solution and Racemic Formoterol in Subjects With Mild to Moderate Chronic Obstructive Pulmonary Disease (COPD)

An Open-Label, Randomized, Multiple Dose, 3-Way Crossover Study of Arformoterol Tartrate Inhalation Solution and Foradil® (Racemic Formoterol) in Subjects With Mild to Moderate Chronic Obstructive Pulmonary Disease (COPD)

NCT00685529•Sumitomo Pharma America, Inc.

View on ClinicalTrials.gov

Summary

The purpose of this study is to compare the blood levels of arformoterol tartrate inhalation solution to racemic formoterol in male and female subjects with mild to moderate Chronic Obstructive Pulmonary Disease (COPD).

Detailed Description

This is an open label, randomized, multiple dose, 3-way crossover, multicenter, inpatient and outpatient study to compare the pharmacokinetic (PK) profile of arformoterol tartrate inhalation solution and Foradil® in male and female subjects with mild to moderate COPD. Up to 36 subjects (with a minimum 40% of each gender) were to be randomized to ensure that at minimum 24 subjects completed the study. The study included 3 dose periods and 3 washout periods. Subjects received 3 different treatments in random order for 13 consecutive days and a single dose on the morning of the 14th day. Subjects will be randomly assigned to 1 of the 6 possible treatment sequences. During each dose period, subjects received medication via nebulization or DPI twice daily for 13 consecutive days and a single dose on the morning of the 14th day. There was be a 10 day washout period between each treatment. Subject participation was be approximately 13 weeks and included a screening visit and 7 study visits. 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

Age

35 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male and female subjects must be at least 35 years old at the time of consent.
•Female subjects less than or equal to 65 years old must have a negative serum pregnancy test at Visit 1 and a urine pregnancy test at Visit 2, confirmed negative prior to randomization. Subjects of childbearing potential must be using an acceptable method of birth control.
•Subjects must have a documented primary clinical diagnosis of non-asthmatic COPD
•Subjects must have a ≥ 15 pack-year smoking history
•Subjects must be in general good health.
•Subjects must have a minimum blood pressure of 105/60 mmHg and a minimum resting pulse of 50 bpm at Screening Visit 1.
•Subjects must have a body mass index (BMI) of at least 16 kg/m2 but no more than 30 kg/m2. (BMI is defined as the subject's weight in kilograms divided by the square of the subject's height in meters.)
•Subjects must be willing to remain in the residential facility for 3 separate 24 hour visits and 3 separate 36-hour visits.
•Subjects must agree to refrain from strenuous activities, as defined by the Principal Investigator, throughout the study, from the screening visit until after the end of study/early termination visit.

Exclusion Criteria

•Subject has had a febrile illness within 72 hours (3 days) before Screening.
•Subject has any clinically significant unstable medical abnormality, chronic disease, or a history of a clinically significant abnormality of the cardiovascular, respiratory, gastrointestinal, hepatic, or renal systems, which, in the opinion of the investigator, may affect the safety of the subject.
•Subject has a history of malignancy or currently has malignancy other than non melanomatous skin cancer. Subjects who have been cancer-free for 5 years or more may be enrolled.
•Subjects with a chest x-ray that suggests a diagnosis other than COPD (e.g., diagnostic of pneumonia, other infection, atelectasis, or pneumothorax or other active/ongoing pulmonary conditions) and taken within 6 months prior to study start. If there is no chest x-ray taken within 6 months prior to study start, or if recent results are unavailable for review, a chest x-ray must be performed.
•Subjects with a history of asthma, with the exception of asthma diagnosed in childhood.
•Subject tests positive at screening for hepatitis B surface antigen or hepatitis C antibody, or the subject has a history of a positive result.
•Subject is known to be seropositive for human immunodeficiency virus (HIV).
•Female subject is pregnant or lactating.
•Female subject who (a) is of childbearing potential and not using contraception or is using hormonal contraception, or (b) is post-menopausal and is taking any form of hormone replacement therapy.
•Subject has a disorder or history of a condition that may interfere with drug absorption, distribution, metabolism, or excretion (e.g., malabsorption, gastrointestinal surgery).
+9 more criteria

Locations (6)

Long Beach, California, United States

Fort Lauderdale, Florida, United States

Raleigh, North Carolina, United States

Simpsonville, South Carolina, United States

Spartanburg, South Carolina, United States

Spokane, Washington, United States

Key Dates

Start Date

April 1, 2005

Primary Completion Date

October 1, 2005

Completion Date

October 1, 2005

Last Updated

February 22, 2012

Enrollment

ACTUAL participants

Conditions

COPD

Interventions

Racemic formoterol

DRUG

Arformoterol tartrate inhalation solution

DRUG

Racemic formoterol

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 22, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Study of Arformoterol Tartrate Inhalation Solution and Racemic Formoterol in Subjects With Mild to Moderate Chronic Obstructive Pulmonary Disease (COPD)

Inclusion Criteria

Exclusion Criteria

cfMSC Stem Cell Therapy Targeting COPD

Effect of Telenursing on Oral Health

Emotional-distress-based Integrated Care Programme in Patients With an Acute Exacerbation of COPD

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