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

• Status: Completed
• Trial end date: 2005-04-13
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Fluticasone; Fluticasone Propionate, Salmeterol Xinafoate Drug Combination; Salmeterol Xinafoate; Xhance

Criteria

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