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

NCT00364442 | Completed Phase 1

• 1 other identifier: SAS10019
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Asthma

Keywords

asthma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (1)

Arm 1

EXPERIMENTAL

investigational drug

Drug: fluticasone propionate/salmeterol

Interventions

fluticasone propionate/salmeterol DRUG

investigational drug

Arm 1

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Documented history of mild or intermittent asthma
• Have PEF and FEV1\>80% predicted
• Not a smoker
• BMI of 19 - 29

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Berlin, 14050, Germany

Location

Related Publications (1)

• This study has not been published in the scientific literature.

  BACKGROUND

Related Links

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

MeSH Terms

Conditions

Asthma

Interventions

Fluticasone-Salmeterol Drug Combination

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Salmeterol Xinafoate; Albuterol; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Fluticasone; Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2006
• First Posted: August 15, 2006
• Study Start: January 28, 2005
• Primary Completion: April 13, 2005
• Study Completion: April 13, 2005
• Last Updated: September 29, 2017

Record last verified: 2017-09

Locations

DE (1)