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

Allergic Rhinitis Clinical Trial

Official title:
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

Clinical Trial Summary

Clinical Trial 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). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00400998
Study type	Interventional
Source	Research Consult GmbH
Contact
Status	Completed
Phase	Phase 2
Start date	March 2006
Completion date	November 2006

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05080322` - Efficacy and Safety of On-demand and Continuous Administration of Nasal Spray in the Treatment of Allergic Rhinitis	Phase 4
Recruiting	`NCT06028490` - A Study of IL4Rα Monoclonal Antibody in Patients With Uncontrolled Seasonal Allergic Rhinitis.	Phase 2
Completed	`NCT04388358` - Traditional Chinese Medicine for the Treatment of Perennial Allergic Rhinitis on Gut Microbiota and Immune-modulation	N/A
Recruiting	`NCT04202263` - Assessment of Suppression of Cutaneous Allergic Responses and Pruritis by Topical Minocycline	Phase 2
Completed	`NCT04078009` - Standardising Nasal Allergen Challenge in Adult With Hay Fever	N/A
Completed	`NCT03644680` - Changes in Adaptive Immune Responses and Effector Cell Responses Upon Nasal Allergen Exposure - a Pilot Study	N/A
Completed	`NCT04541004` - Adolescent Mite Allergy Safety Evaluation	Phase 3
Recruiting	`NCT05378594` - HDM and Silver Birch NAC Standardisation	N/A
Not yet recruiting	`NCT05684380` - Efficacy and Safety of MAZ-101 in the Treatment of Persistent Allergic Rhinitis (PER)	Phase 3
Completed	`NCT02943720` - ATIBAR - Efficacy and Safety of Two Doses of AllerT in Patients Allergic to Birch Pollen	Phase 2
Completed	`NCT02910401` - Clinical Response to Rhinovirus Challenge	Phase 2
Not yet recruiting	`NCT01014325` - Safety and Efficacy Study With Allergen Extracts of House Dust Mites for Specific Sublingual Immunotherapy	Phase 3
Completed	`NCT02556801` - Efficacy and Safety of SUBLIVAC Phleum for Immunotherapy of Grass Pollen-Allergy	Phase 2
Not yet recruiting	`NCT02233426` - Effect of Hypertonic Solutions on Allergic Rhinitis Patients	N/A
Completed	`NCT02352168` - Airway Inflammation in Children With Allergic Rhinitis and Intervention	N/A
Completed	`NCT01946035` - Alpha-Blockers in Allergic Rhinitis (MAN 01)	Phase 4
Completed	`NCT01918956` - PURETHAL Birch RUSH Study	Phase 4
Completed	`NCT01682070` - SUBLIVAC FIX Phleum Pratense DT/DRF	Phase 2
Recruiting	`NCT01454492` - The Relationship Between Allergic Rhinitis and Geographic Tongue	N/A
Completed	`NCT01438463` - PURETHAL® Mites Dose Range Finding Study in Patients With Persistent Allergic Rhinitis/Rhinoconjunctivitis	Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.