Repeat Dose Study of Fluticasone Propionate/Salmeterol Versus Fluticasone Propionate + Salmeterol In Asthmatics

GlaxoSmithKline12 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Asthma

Interventions

fluticasone propionate/salmeterolDRUG

investigational drug

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

Inclusion criteria: * Documented history of mild or intermittent asthma * Have PEF and FEV1\>80% predicted * Not a smoker * BMI of 19 - 29 Exclusion criteria: * Have had a life threatening episode of asthma * Have had a respiratory tract infection in the last four weeks * Have other respiratory disease * Have taken certain medications within restricted time periods

Locations (1)

GSK Investigational Site

Berlin, Germany

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

Time frame: Administration occurred over 14 days and tolerability

Data from ClinicalTrials.gov

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