Study In Airway Physiology In Children - Tabular View

Tracking Information

First Received Date ^ICMJE

September 9, 2005

Last Updated Date

October 15, 2008

Start Date ^ICMJE

January 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

sRAW (k.Pa.s) measured before the study medication dose at the end of treatment (week 6)

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00169546 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

sRAW measured pre-dose at Week 3. sRAW measured 48 hours after last study medication dose. % symptom-free days over Weeks 1-6. % symptom-free nights over Weeks 1-6. Type and frequency of adverse events.

Original Secondary Outcome Measures ^ICMJE

sRAW measured pre-dose at Week 3.
sRAW measured 48 hours after last study medication dose.
% symptom-free days over Weeks 1-6.
% symptom-free nights over Weeks 1-6.
Type and frequency of adverse events.

Descriptive Information

Brief Title ^ICMJE

Study In Airway Physiology In Children

Official Title ^ICMJE

Comparator Study to Demonstrate Superiority of Salmeterol/Fluticasone Propionate 50/100mcg bd Over Fluticasone Propionate 200mcg bd With Respect to Airway Physiology in Children Treated for 6 Weeks.

Brief Summary

Comparison of two asthma treatments by lung function measures.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Asthma

Intervention ^ICMJE

Drug: Salmeterol/fluticasone propionate
Drug: Fluticasone propionate

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:

Currently receiving 200-800mcg/day beclomethasone dipropionate.
sRAW value of 1.3 kPa's.

Exclusion Criteria:

3 or more courses of oral steroids in last 12 months.

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

New Zealand, United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00169546

Responsible Party

Study Director, GSK

Study ID Numbers ^ICMJE

SAM40100

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

October 2008

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