Investigate Two Trial Models; Vienna Challenge Chamber (in and Out of Season) and Park Study (in Season) Using a Drug for Seasonal Allergic Rhinitis
Condition: Allergic Rhinitis; Rhinitis, Allergic, Seasonal
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 2

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).
    

Intervention name(s): Fluticasone Propionate; Matched FPANS placebo
Intervention type(s): Drug; Other
Intervention description(s): 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.; 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.
Intervention MeSH terms: Fluticasone; Xhance
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Seasonal Allergic Rhinitis; Quality of Life; Efficacy; Validation; Fluticasone Propionate