Repeat Dose Study of Fluticasone Propionate/Salmeterol Versus Fluticasone Propionate + Salmeterol In Asthmatics
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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.
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
Actual Study Start Date
January 28, 2005
Primary Completion Date
April 13, 2005
Study Completion Date
April 13, 2005
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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 Outcome Measures
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 ]
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Ages Eligible for Study:
18 Years to 55 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Documented history of mild or intermittent asthma
Have PEF and FEV1>80% predicted
Not a smoker
BMI of 19 - 29
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