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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00400998 |
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).
Condition | Intervention |
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Allergic Rhinitis |
Drug: Fluticasone Propionate |
Study Type: | Observational |
Study Design: | Retrospective |
Official Title: | See Detailed Description |
Enrollment: | 48 |
Study Start Date: | March 2006 |
Study Completion Date: | November 2006 |
A randomised, double blind, placebo controlled, two-way crossover, three 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 repeat doses of fluticasone propionate in subjects with seasonal allergic rhinitis (SAR).
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
They have demonstrated an ability to use the intranasal spray
Exclusion Criteria:
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | HH3104994 |
Study First Received: | November 15, 2006 |
Last Updated: | October 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00400998 History of Changes |
Health Authority: | Austria: Federal Office for Safety in Health Care |
Fluticasone Propionate Validation Seasonal Allergic Rhinitis Efficacy Quality of Life |
Anti-Inflammatory Agents Otorhinolaryngologic Diseases Respiratory Tract Infections Respiratory Tract Diseases Rhinitis, Allergic, Seasonal Anti-Asthmatic Agents |
Fluticasone Quality of Life Rhinitis Anti-Allergic Agents Peripheral Nervous System Agents Bronchodilator Agents |
Anti-Inflammatory Agents Respiratory System Agents Otorhinolaryngologic Diseases Physiological Effects of Drugs Anti-Asthmatic Agents Rhinitis Anti-Allergic Agents Nose Diseases Pharmacologic Actions |
Respiratory Tract Diseases Respiratory Tract Infections Autonomic Agents Therapeutic Uses Fluticasone Peripheral Nervous System Agents Dermatologic Agents Bronchodilator Agents |