Chronic-Dose Safety and Efficacy Study of a Bronchodilator Inhaler in Pediatric Asthmatics - Tabular View

Tracking Information
First Received Date ^ICMJE	March 28, 2006
Last Updated Date	December 15, 2006
Start Date ^ICMJE	April 2006
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00308685 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Chronic-Dose Safety and Efficacy Study of a Bronchodilator Inhaler in Pediatric Asthmatics
Official Title ^ICMJE
Brief Summary	This study is designed to evaluate the repeat-dose safety and effectiveness of a bronchodilator inhaler relative to placebo (inactive drug inhaler) in children aged 4-11 years with asthma. The dosing period lasts three weeks and starts following a three-week run-in period.
Detailed Description
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Asthma
Intervention ^ICMJE	Drug: Albuterol
Study Arms / Comparison Groups
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
Enrollment ^ICMJE
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	Inclusion Criteria: Persistent asthma of a minimum of six months duration that has been stable for at least four weeks prior to screening Male and female children aged 4-11 years, inclusive, with predicted forced expiratory volume in 1 second (FEV1) 60-90% Ability to perform spirometry Demonstrate 12% airways reversibility Exclusion Criteria: Require continuous treatment with beta-blockers, monoamine oxidase inhibitors, tricyclic antidepressants, anticholinergics, and/or systemic corticosteroids Presence of any non-asthmatic clinically-significant acute or uncontrolled chronic diseases
Gender	Both
Ages	4 Years to 11 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00308685
Responsible Party
Study ID Numbers ^ICMJE	IXR-303-25-167
Study Sponsor ^ICMJE	Teva Global Respiratory Research LLC
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Teva Global Respiratory Research LLC
Verification Date	December 2006
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP