Chronic-Dose Safety and Efficacy Study of Albuterol-HFA-MDI In Pediatric Asthmatics - Tabular View

Tracking Information

First Received Date ^ICMJE

December 18, 2007

Last Updated Date

August 4, 2008

Start Date ^ICMJE

August 2007

Primary Completion Date

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

Current Primary Outcome Measures ^ICMJE

The primary objective is to evaluate the chronic-dose safety and efficacy of Albuterol-HFA-MDI relative to placebo in pediatric asthmatics. [ Time Frame: 21 days of treatment ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00577655 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Baseline-adjusted area-under-the effect curve for percent of predicted FEV1 and PEF over six hours post-dose. [ Time Frame: 6-hours ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Baseline-adjusted area-under-the effect curve for percent-=prdicted FEV1 and PEF over six hours post-dose. [ Time Frame: 6-hours ] [ Designated as safety issue: Yes ]

Descriptive Information

Brief Title ^ICMJE

Chronic-Dose Safety and Efficacy Study of Albuterol-HFA-MDI In Pediatric Asthmatics

Official Title ^ICMJE

Phase 3 Study to Evaluate the Chronic-Dose Safety and Efficacy of Albuterol-HFA-MDI Relative to Placebo in Pediatric Asthmatics

Brief Summary

The primary objective of this study is to evaluate the chronic-dose and efficacy of Albuterol-HFA-MDI relative to placebo in pediatric asthmatics.

Detailed Description

Eligible patients will be randomized to receive one of the following two treatments four times a day for 21 days:

Placebo-HFA-MDI (Albuterol 0 mcg) Albuterol-HFA-MDI (Albuterol 180 mcg)

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Asthma

Intervention ^ICMJE

Drug: Albuterol-HFA-MDI and placebo
Drug: Albuterol-HFA-MDI

Study Arms / Comparison Groups

Active Comparator: Albuterol-HFA-MDI
Placebo Comparator: Placebo-HFA-MDI

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

104

Completion Date

July 2008

Primary Completion Date

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

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Male and female child aged 4-11 years, inclusive Asthma of a minimum of six months duration that has been stable for at least four weeks prior to screening.

Exclusion Criteria:

Hospitalization for acute asthma exacerbation greater than two years in 12 months prior to screening and/or received ER treatment or hospitalization for asthma exacerbation.

Gender

Both

Ages

4 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

NCT00577655

Responsible Party

Ivax Research, LLC, Ivax Research, LLC

Study ID Numbers ^ICMJE

IXR-302-25-105

Study Sponsor ^ICMJE

Teva Global Respiratory Research LLC

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Teva Study Physician MD

Teva R&D Initiative

Information Provided By

Teva Global Respiratory Research LLC

Verification Date

August 2008

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