A Safety and Tolerability Study of Arformoterol Tartrate Inhalation Solution in Pediatric Subjects - Tabular View

Tracking Information

First Received Date ^ICMJE

December 21, 2007

Last Updated Date

January 6, 2009

Start Date ^ICMJE

January 2008

Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00583947 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

A Safety and Tolerability Study of Arformoterol Tartrate Inhalation Solution in Pediatric Subjects

Official Title ^ICMJE

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

Brief Summary

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

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.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Asthma

Intervention ^ICMJE

Drug: arformoterol inhalation solution; levalbuterol hydrochloride inhalation solution

Study Arms / Comparison Groups

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

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

December 2008

Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Both

Ages

2 Years to 11 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00583947

Responsible Party

James M. Hinson Jr., MD, FCCP, CPI, Unicorn Pharma Consulting

Study ID Numbers ^ICMJE

091-029

Study Sponsor ^ICMJE

Sepracor, Inc.

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Pulmonary Medical Director

Unicorn Pharma Consulting

Information Provided By

Sepracor, Inc.

Verification Date

January 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP