Repeat Dose Study of Fluticasone Propionate/Salmeterol Versus Fluticasone Propionate + Salmeterol In Asthmatics
Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on June 20, 2008
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
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.
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: Treatment, Randomized, Double-Blind, Active Control, Crossover Assignment, Pharmacokinetics/Dynamics Study
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
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
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
Locations and Contacts
GSK Clinical Trials Call Center, Berlin 14050, Germany
Additional Information
Starting date: January 2005
Last updated: September 24, 2007
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