Rhinitis, Allergic, Perennial and Seasonal Clinical Trial
Official title:
A Randomised, Double-blind, Placebo-controlled, 3 Way, Incomplete Block Cross Over Study in Subjects With Allergic Rhinitis to Assess the Effect of Once Daily Single and Repeat Doses of Intranasal Fluticasone Furoate/Levocabastine Fixed Dose Combination (FDC) Relative to Levocabastine and Fluticasone Furoate Alone on the Onset and Magnitude of Symptoms of Rhinitis in an Allergen Challenge Chamber
This study will be a randomised, double blind, placebo controlled, 3-way, incomplete block crossover study to evaluate the effect of single and repeat doses of levocabastine, FF, placebo and a FDC of FF/levocabastine administration in AR subjects. The total expected study duration for each individual participating in the study will be a maximum of up to 20 weeks (including the screening and follow-up). This will be a three period study and subjects will be assigned to a sequence of three treatments. There will be a wash-out period of 14-28 days between two treatment periods. The rational for this study is to demonstrate proof of concept with the FDC of FF and levocabastine compared with each of the components administered alone.
n/a
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02424539 -
A Study to Compare the Efficacy and Safety of Fluticasone Furoate Nasal Sprays (FFNS) 55 Microgram (mcg) and 110 mcg in Chinese Pediatric Subjects With Allergic Rhinitis (AR)
|
Phase 4 | |
Completed |
NCT01949051 -
A Study to Assess Intranasal Repeat Dose Effect of Levocabastine in the Subjects With Allergic Rhinitis
|
Phase 2 | |
Completed |
NCT01962467 -
A Relative Bioavailability Study of Fluticasone Furoate and Levocabastine
|
Phase 1 | |
Completed |
NCT01001130 -
Regulatory AVAMYS Nasal Spray PMS
|
N/A | |
Completed |
NCT01622283 -
Pharmacokinetic Study of Levocetirizine Oral Solution
|
Phase 1 | |
Completed |
NCT02397915 -
Patient Preference Study of Fluticasone Furoate and Mometasone Furoate Nasal Sprays
|
Phase 4 | |
Completed |
NCT01445262 -
Drug Use Investigation for XYZAL®
|
N/A | |
Completed |
NCT01916226 -
A Comparator Study of Fluticasone Propionate Nasal Spray Verses (vs) Cetirizine in the Treatment of Seasonal Allergic Rhinitis
|
Phase 4 | |
Completed |
NCT00109486 -
Safety Study To Assess Growth In Children With Seasonal Allergic And/Or Perennial Allergic Rhinitis Treated With GW685698X Aqueous Nasal Spray Or Placebo Nasal Spray
|
Phase 3 |