Official Title: “A Cumulative Dose Safety and Tolerability Crossover Study of Arformoterol Tartrate Inhalation Solution and Levalbuterol Hydrochloride Inhalation Solution in Pediatric Subjects (Aged 2 to 11 Years of Age) With Asthma”

To determine the safety and tolerability of Arformoterol Tartrate in children with asthma

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Crossover Assignment, Safety Study

Study Primary Completion Date: November 2008

A randomized, double-blind two-way crossover study of three cumulative doses of arformoterol (7.5 ug per nebulization) and levalbuterol (0.63 mg per nebulization) given over a one hour period, followed by a single open-label treatment day with three cumulative doses of arformoterol 15 ug in subjects 2-11 years of age with asthma.

Intervention(s) in this Clinical Trial

• Drug: arformoterol inhalation solution; levalbuterol hydrochloride inhalation solution
  • arformoterol (7.5 ug per nebulization) and levalbuterol hydrochloride(0.63 mg per nebulization) and arformoterol (15 ug per nebulization)

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • - Arformoterol, 7.5 ųg per nebulization
• Active Comparator: 2
  • - Levalbuterol Hydrochloride(0.63 mg per nebulization) & Arformoterol (15 ųg per nebulization)

Primary Measures

• To compare the safety and tolerability of cumulative dosing with arformoterol tartrate inhalation solution versus levalbuterol hydrochloride inhalation solution (3 cumulative nebulizations in one hour) in pediatric subjects with asthma.
  • Time Frame: 42 days
    Safety Issue?: Yes

Secondary Measures

• To investigate the FEV1 response (in children 6 and older and for children 5 or younger who can perform spirometry) to cumulative dosing with arformoterol tartrate inhalation solution versus levalbuterol hydrochloride inhalation solution.
  • Time Frame: 42 days
    Safety Issue?: Yes

Inclusion Criteria:

• Male and Female
• Between Age 2 and 11, inclusive, at the time of consent
• Weight equal to or greater than 15 Kg
• History of physician-diagnosed asthma of at least 2 years duration for children age 6 and older, and at least 1 year duration for children 5 and younger.

Exclusion Criteria:

• Female subject who is pregnant or lactating.
• Subject who has a history of hospitalization for asthma within one year, or who is scheduled for in-patient hospitalization, including elective surgery during the course of the trial.
• Subject with any history of life-threatening asthma defined as a history of asthma episodes requiring intubation, associated with hypercapnia, respiratory arrest, or hypoxic seizures.
• Subject with a history of cancer.
• Subject with hyperthyroidism, diabetes, hypertension, cardiac diseases or seizure disorders.
• Subject with a history of cigarette smoking or use of any tobacco products.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 2 Years

Maximum Age for this Clinical Trial: 11 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Sepracor, Inc.

Overall Clinical Trial Officials and Contacts

Pulmonary Medical Director Study Chair Unicorn Pharma Consulting  

Overall Contact: Sepracor Central Contact 1-866-503-6351 

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00583947

Study ID Number: 091-029

ClinicalTrials.gov Identifier: NCT00583947

Health Authority: United States: Food and Drug Administration

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