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

NCT00685529 | Completed Phase 2

• 1 other identifier: 091-019
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 6

Brief 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).

Conditions

COPD

Keywords

COPD; Arformoterol; formoterol

Outcome Measures

Primary Outcomes (1)

• The primary endpoint for this study is exposure to (R,R)-formoterol, measured by the PK parameters AUC(0-τ) and Cmax

  Treatment/Washout 1: Days 1, 12-18; T/W 2: 24, 35-40; T/W 3: 47, 58-64, EOT: 70

Secondary Outcomes (5)

• Additional PK parameters of (R,R)-formoterol include tmax, t ½, and AUC(0-∞)

  Treatment/Washout 1: Days 1, 12-18; T/W 2: 24, 35-40; T/W 3: 47, 58-64, EOT: 70

• Accumulation ratios for (R,R)-formoterol as measured by RCmax and RAUC(0-τ)

  Treatment/Washout 1: Days 1, 12-18; T/W 2: 24, 35-40; T/W 3: 47, 58-64, EOT: 70

• PK parameters for (S,S)-formoterol following racemic formoterol administration are AUC(0-τ), Cmax, tmax, t ½, and AUC(0-∞)

  Treatment/Washout 1: Days 1, 12-18; T/W 2: 24, 35-40; T/W 3: 47, 58-64, EOT: 70

• Accumulation ratios for (S,S)-formoterol as measured by RCmax and RAUC(0-τ)

  Days 1, 12, 13, 14, 15, 16, 17,18

• FEV1 and % predicted FEV1

  Treatment/Washout 1: Days 1, 14-15; TW2: 24, 37-38; TW3: 47, 60-61

Study Arms (3)

A

ACTIVE COMPARATOR

12 µg of racemic formoterol fumarate BID

Drug: Racemic formoterol

B

EXPERIMENTAL

15 µg of nebulized arformoterol tartrate inhalation solution BID

Drug: Arformoterol tartrate inhalation solution

C

ACTIVE COMPARATOR

24 µg of racemic formoterol fumarate BID

Drug: Racemic formoterol

Interventions

Racemic formoterol DRUG

12 µg of racemic formoterol fumarate BID

Also known as: Foradil®, Aerolizer

A

Arformoterol tartrate inhalation solution DRUG

15 µg of nebulized arformoterol tartrate inhalation solution BID

Also known as: Brovana, (R,R)-formoterol

B

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• Subject has participated in any investigational study within 30 days prior to screening or is currently participating in another clinical trial.
• Subject is a staff member or relative of a staff member.
• Subject has a positive urine alcohol test during screening. Subjects with a known history of alcohol use may be enrolled in the study if the subject's alcohol use is not indicative of abuse. Abuse is defined as current consumption of more than three alcoholic beverages per day.
• Subject has a history or suspected history of abuse of a barbiturate, amphetamine, or narcotic and/or has a positive screening result for any of these substances at study start.
• Subject has a history of allergic reaction to the study medication or any components of the study medications.

Sponsors & Collaborators

• Sumitomo Pharma America, Inc.: lead

Study Sites (6)

Unknown Facility

Long Beach, California, United States

Location

Unknown Facility

Fort Lauderdale, Florida, United States

Location

Unknown Facility

Raleigh, North Carolina, United States

Location

Unknown Facility

Simpsonville, South Carolina, United States

Location

Unknown Facility

Spartanburg, South Carolina, United States

Location

Unknown Facility

Spokane, Washington, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Formoterol Fumarate

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2008
• First Posted: May 28, 2008
• Study Start: April 1, 2005
• Primary Completion: October 1, 2005
• Study Completion: October 1, 2005
• Last Updated: February 22, 2012

Record last verified: 2012-02

Locations

US (6)