A Safety and Tolerability Study of Arformoterol Tartrate Inhalation Solution in Pediatric Subjects
Information source: Sepracor, Inc.
Information obtained from ClinicalTrials.gov on August 08, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: arformoterol inhalation solution; levalbuterol hydrochloride inhalation solution (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Sepracor, Inc. Official(s) and/or principal investigator(s):
Pulmonary Medical Director, Study Chair, Affiliation: Unicorn Pharma Consulting
Overall contact:
Sepracor Central Contact, Phone: 1-866-503-6351
Summary
To determine the safety and tolerability of Arformoterol Tartrate in children with asthma
Clinical Details
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
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Crossover Assignment, Safety Study
Primary outcome: 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.
Secondary outcome: 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.
Detailed description:
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.
Eligibility
Minimum age: 2 Years.
Maximum age: 11 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Sepracor Central Contact, Phone: 1-866-503-6351
Oxford, Alabama 36203, United States; Recruiting
Little Rock, Arkansas 72204, United States; Withdrawn
Little Rock, Arkansas 72211, United States; Withdrawn
Beverly Hills, California 90211, United States; Recruiting
Orange, California 92868, United States; Recruiting
Stockton, California 95207, United States; Withdrawn
Long Beach, California 90808, United States; Withdrawn
Denver, Colorado 80230, United States; Withdrawn
Savannah, Georgia 31406, United States; Recruiting
Normal, Illinois 61761, United States; Recruiting
Kansas City, Missouri 64108, United States; Withdrawn
Oklahoma City, Oklahoma 73112, United States; Recruiting
Oklahoma City, Oklahoma 73120, United States; Recruiting
Medford, Oregon 97504, United States; Recruiting
Portland, Oregon 97213, United States; Recruiting
Upland, Pennsylvania 19013, United States; Recruiting
Spartanburg, South Carolina 29303, United States; Recruiting
Orangeburg, South Carolina 29118, United States; Recruiting
Charleston, South Carolina 29414, United States; Withdrawn
Orangeburg, South Carolina, United States; Withdrawn
Dallas, Texas 75230, United States; Recruiting
South Burlington, Vermont, United States; Withdrawn
Richmond, Virginia 23229, United States; Recruiting
Burke, Virginia 22015, United States; Recruiting
Additional Information
Xopenex HCI Patient Prescribing Information Brovana Patient Medication Guide
Starting date: January 2008
Ending date: November 2008
Last updated: May 19, 2008
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