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...
Date First Received: August 11, 2006
Last Updated: October 9, 2008
Verified by: GlaxoSmithKline, October 2008
Clinical Trial Phase: Phase 1 | Start Date: January 2005
Overall Status: Completed
Estimated Enrollment: 12
Brief Summary
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”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Crossover Assignment, Pharmacokinetics/Dynamics Study
Intervention(s) in this Clinical Trial
- Drug: fluticasone propionate/salmeterol
Outcome Measures for this Clinical Trial
Primary Measures
- 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
- Time Frame: Administration occurred over 14 days and tolerability
Secondary 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
- Time Frame: Administration occurred over 14 days and tolerability
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 55 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: GlaxoSmithKline
Overall Clinical Trial Officials and Contacts
GSK Clinical Trials, BA, BS, PhD Study Director GlaxoSmithKline
Additional Information
Information obtained from ClinicalTrials.gov on February 04, 2010
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00364442
Study ID Number: SAS10019
ClinicalTrials.gov Identifier: NCT00364442
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Clinical Trials Authorship and Review
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