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

This Tabular View shows the required WHO registration data elements as marked by ^†

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

Descriptive Information
Brief Title ^†	Chronic-Dose Safety and Efficacy Study of a Bronchodilator Inhaler in Pediatric Asthmatics
Official Title ^†
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 ^†	Interventional
Study Design ^†	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Condition ^†	Asthma
Intervention ^†	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 ^†	Completed
Enrollment ^†
Completion Date
Primary Completion Date
Eligibility Criteria ^†	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 ^††
Location Countries ^†	United States
Expanded Access Status

Administrative Information
NCT ID ^†	NCT00308685
Responsible Party
Secondary IDs ^††
Study Sponsor ^†	Teva Global Respiratory Research LLC
Collaborators ^††
Investigators ^†
Information Provided By	Teva Global Respiratory Research LLC
Verification Date	December 2006
^† Required WHO trial registration data element. ^†† WHO trial registration data element that is required only if it exists.