NCT00400998

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

A Randomised, Double Blind, Placebo Controlled, 2-way Crossover, 3 Phase Study, to Investigate the Trial Models, Vienna Challenge Chamber, in and Out of Season, and Park Study in Season and the Clinical Efficacy of Rpt Doses of Fluticasone Propionate in Subjects With Seasonal Allergic Rhinitis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Research Consult GmbH · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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. This will be a single-centre, randomised, double-blind, placebo-controlled, 3 phase study in 40 male or female subjects with seasonal allergic rhinitis. The subjects will be randomised to receive either fluticasone propionate aqueous nasal spray or matched placebo. The study consists of three phases with each phase consists of 2 treatment periods. A screening visit will be followed by Phase 1 (Vienna Chamber Challenge out of season), Phase 2 (Park Study, in season) and Phase 3 (Vienna Chamber Challenge in season). There will be a follow-up visit after Phase 1 and Phase 2 \& 3 will be separated by a 10 day wash-out period. A follow-up visit will be completed 7-14 days after the last received dose. Intranasal fluticasone propionate will be administered daily for 8 days in the VCC and up to 14 days in the Park Study. Primary assessment will consist of major symptoms complex (MSC) during a 5-hour pollen allergen challenge in the Vienna Challenge Chamber (VCC) following final dosing on Day 8 and following final dosing between Day 8 and Day 14 in the Park Study. In addition, nasal flow measured by anterior rhinomanometry, wet tissue weight (as a surrogate of nasal secretion) and categorical scores for ocular symptoms, cough, itchy throat and itchy ears will be measured on day 8 (VCC) or on a day between 8-14 (Park).

Conditions

• Allergic Rhinitis
• Rhinitis, Allergic, Seasonal

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2006-03-01
• Primary completion: 2006-11-01
• Completion: 2006-11-01
• First posted: 2006-11-17
• Last updated: 2018-01-10

Locations

1 site across 1 country: Austria