A Study In Pediatric Subjects With Asthma Using ADVAIR HFA, ADVAIR HFA With Spacer, And ADVAIR DISKUS - Tabular View

Tracking Information

First Received Date ^ICMJE

November 15, 2006

Last Updated Date

May 15, 2009

Start Date ^ICMJE

October 2006

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

PD of Fluticasone as measured by serum cortisol followed by doses of ADVAIR HFA and ADVAIR DISKUS [ Time Frame: 3 Weeks ]

Original Primary Outcome Measures ^ICMJE

PD of Fluticasone as measured by serum cortisol followed by doses of ADVAIR HFA and ADVAIR DISKUS

Change History

Complete list of historical versions of study NCT00400608 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To assess the exposure of FP and Salmeterol following the doses of ADVAIR HFA and ADVAIR DISKUS as well as assessing safety measurements based on adverse event reporting [ Time Frame: 3 Weeks ]

Original Secondary Outcome Measures ^ICMJE

To assess the exposure of FP and Salmeterol following the doses of ADVAIR HFA and ADVAIR DISKUS as well as assessing safety measurements based on adverse event reporting

Descriptive Information

Brief Title ^ICMJE

A Study In Pediatric Subjects With Asthma Using ADVAIR HFA, ADVAIR HFA With Spacer, And ADVAIR DISKUS

Official Title ^ICMJE

See Detailed Description

Brief Summary

Collect PK/PD data for this age group to compare ADVAIR DISKUS with ADVAIR HFA

Detailed Description

A repeat-dose open label randomized incomplete block design in pediatric subjects with asthma, ages 4-11 years, to compare systemic exposure and pharmacodynamics of fluticasone propionate and salmeterol following ADVAIR HFA 45/21mcg(2 inhalations), ADVAIR HFA 45/21mcg(2 inhalations) with Aerochamber Plus Spacer and ADVAIR DISKUS 100/50 twice daily

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Single Group Assignment, Pharmacokinetics/Dynamics Study

Condition ^ICMJE

Asthma

Intervention ^ICMJE

Drug: ADVAIR HFA
Drug: ADVAIR DISKUS

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

February 2007

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion criteria:

Subjects with mild asthma
No significant medical conditions at screen
Weigh at least 20 kg

Exclusion criteria:

No clinical abnormalities at screen visit
Asthma control at least 3 months prior with anti-steroidal medication only

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

NCT00400608

Responsible Party

Study Director, GSK

Study ID Numbers ^ICMJE

SAS105519

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

May 2009

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