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

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Asthma

Intervention: fluticasone propionate/salmeterol (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, BA, BS, PhD, Study Director, Affiliation: GlaxoSmithKline


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.

Clinical Details

Official title: A Repeat Dose, Randomised, Double Blind, 2-Way Crossover Study to Assess the Safety and Systemic Exposure of SERETIDE/VIANI 50/50 COA Compared to Concurrent Administration of Individual Fluticasone Propionate 50 and Salmeterol 50 DISKUS Inhalers in Subjects Aged 18 - 55 Years With Mild Asthma

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome: 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

Secondary outcome: Comparing changes in PD parameters & PK parameters between a low dose of fluticasone propionate/salmeterol compared to concurrent administration of fluticasone propionate and salmeterol


Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.


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 and Contacts

GSK Investigational Site, Berlin 14050, Germany
Additional Information

Starting date: January 2005
Last updated: October 9, 2008

Page last updated: August 23, 2015

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