A Repeat Dose, Randomised, Double Blind, 2-way Crossover Study to Assess the Safety and Systemic Exposure of an Investigational Formulation Compared to Concurrent Administration of Individual Fluticasone Propionate 50 and Salmeterol 50 DISKUS Inhalers in Subjects Aged 18 - 55 Years With Mild Asthma

GlaxoSmithKline1 site in 1 country12 target enrollmentJanuary 28, 2005

ConditionsAsthma

Interventionsfluticasone propionate/salmeterol

Drugsfluticasone propionate/salmeterol

Overview

Phase: Phase 1
Intervention: fluticasone propionate/salmeterol
Conditions: Asthma
Sponsor: GlaxoSmithKline
Enrollment: 12
Locations: 1
Primary Endpoint: The primary objective was to look at the safety and tolerability of a low dose of fluticasone propionate/salmeterol compared to concurrent administration of fluticasone propionate and salmeterol
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

A new formulation of Fluticasone propionate/Salmeterol comparing a lower dose of fluticasone propionate and salmeterol was compared with concurrent administration of fluticasone propionate and salmeterol. Administration occurred over 14 days and tolerability, PK (pharmacokinetic) and PD (pharmacodynamic) measurements were performed.

Registry

clinicaltrials.gov

Start Date

January 28, 2005

End Date

April 13, 2005

Last Updated

8 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

GlaxoSmithKline

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arms & Interventions

Arm 1

investigational drug

Intervention: fluticasone propionate/salmeterol

Outcomes

Primary Outcomes

The primary objective was to look at the safety and tolerability of a low dose of fluticasone propionate/salmeterol compared to concurrent administration of fluticasone propionate and salmeterol

Time Frame: Administration occurred over 14 days and tolerability

Secondary Outcomes

Comparing changes in PD parameters & PK parameters between a low dose of fluticasone propionate/salmeterol compared to concurrent administration of fluticasone propionate and salmeterol(Administration occurred over 14 days and tolerability)