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

This study has been completed.
Information provided by:
GlaxoSmithKline Identifier:
First received: August 11, 2006
Last updated: October 9, 2008
Last verified: October 2008
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.

Condition Intervention Phase
Drug: fluticasone propionate/salmeterol
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

Primary Outcome 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 ]

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 ]

Enrollment: 12
Study Start Date: January 2005

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00364442

GSK Investigational Site
Berlin, Germany, 14050
Sponsors and Collaborators
Study Director: GSK Clinical Trials, BA, BS, PhD GlaxoSmithKline
  More Information

Responsible Party: Study Director, GSK Identifier: NCT00364442     History of Changes
Other Study ID Numbers: SAS10019 
Study First Received: August 11, 2006
Last Updated: October 9, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by GlaxoSmithKline:

Additional relevant MeSH terms:
Fluticasone Propionate, Salmeterol Xinafoate Drug Combination
Salmeterol Xinafoate
Adrenergic Agents
Adrenergic Agonists
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Anti-Allergic Agents
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Autonomic Agents
Bronchodilator Agents
Dermatologic Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Respiratory System Agents
Sympathomimetics processed this record on May 25, 2016