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Investigate Two Trial Models; Vienna Challenge Chamber (in and Out of Season) and Park Study (in Season) Using a Drug for Seasonal Allergic Rhinitis

NCT00400998 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2018-01-10

No results posted yet for this study

Summary

The aim of the study is to investigate the trial models, Vienna Challenge Chamber (VCC), in and out of season, and Park Study in season and the clinical efficacy of repeat doses of fluticasone propionate in subjects with seasonal allergic rhinitis.

Conditions

  • Allergic Rhinitis
  • Rhinitis, Allergic, Seasonal

Interventions

DRUG

Fluticasone Propionate

Subjects will receive the following treatment regimen over one of two dosing periods within each of the three study phases: \- Intranasal FPANS (Fluticasone Propionate aqueous nasal spray) 200 mcg once daily for 8 to 14 days i.e. 4 actuations (2 per nostril) daily, where each actuation delivers a volume of 100 mcL (microlitres) i.e. 50 mcg fluticasone propionate.

OTHER

Matched FPANS placebo

Subjects will receive the following placebo treatment regimen over one of two dosing periods within each of the three study phases: * Intranasal FPANS placebo once daily for 8 to 14 days (i.e. 4 actuations (2 per nostril) daily, where each actuation delivers a volume of 100 mcL.

Sponsors & Collaborators

  • Research Consult GmbH

    lead INDUSTRY

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-03-31
Primary Completion
2006-11-30
Completion
2006-11-30

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00400998 on ClinicalTrials.gov