Repeat Dose Study of Fluticasone Propionate/Salmeterol Versus Fluticasone Propionate + Salmeterol In Asthmatics
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...
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”
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: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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 Investigator Information
Lead Investigator: GlaxoSmithKline Industry
Overall Clinical Trial Officials and Contacts
GSK Clinical Trials, BA, BS, PhD Study Director GlaxoSmithKline
Additional Information
Information obtained from ClinicalTrials.gov on February 08, 2012
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 content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00364442
