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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00364442
• Other study ID #: SAS10019
• Status: Completed
• Phase: Phase 1
• First received: August 11, 2006
• Last updated: September 27, 2017
• Start date: January 28, 2005
• Est. completion date: April 13, 2005

Study information

• Verified date: September 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: April 13, 2005
• Est. primary completion date: April 13, 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• fluticasone propionate/salmeterol
investigational drug

Locations

Country	Name	City	State
Germany	GSK Investigational Site	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Germany, 

References & Publications (1)

This study has not been published in the scientific literature.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		Administration occurred over 14 days and tolerability
Secondary	Comparing changes in PD parameters & PK parameters between a low dose of fluticasone propionate/salmeterol compared to concurrent administration of fluticasone propionate and salmeterol		Administration occurred over 14 days and tolerability

External Links

•   Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
•   Results for study SAS10019 can be found on the GSK Clinical Study Register.