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

Phase 1

Completed

• Conditions: Asthma
• Interventions: Drug: fluticasone propionate/salmeterol

• Registration Number: NCT00364442
• Lead Sponsor: GlaxoSmithKline

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-01-28
• Primary Completion: 2005-04-13
• Study Completion: 2005-04-13
• Study First Submitted: 2006-08-11
• Study First Submitted QC: 2006-08-11
• Study First Posted: 2006-08-15
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-27
• Last Update Posted: 2017-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Arm 1	fluticasone propionate/salmeterol	investigational drug

Primary Outcome Measures

Name	Time	Method
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	Administration occurred over 14 days and tolerability

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

GSK Investigational Site; 🇩🇪 Berlin, Germany