Rhinitis, Allergic, Seasonal Clinical Trial
Official title:
A Double-Blind, Randomized, Placebo Controlled, Parallel Group, Multi-Site Study to Compare the Clinical Equivalence of Fluticasone Furoate Nasal Spray (Lek Pharmaceuticals) With Veramyst® Nasal Spray (GlaxoSmithKline) in the Relief of the Signs and Symptoms of Seasonal Allergic Rhinitis
This study compared the safety and efficacy of a generic fluticasone furoate (Lek Pharmaceuticals) nasal spray to the reference listed drug in the treatment of seasonal allergic rhinitis. Additionally both the test and the reference formulations were tested for superiority against a placebo nasal spray.
The study was designed as a double-blind, randomized, placebo-controlled, parallel group, multi-site to compare the clinical equivalence of the test formulation of fluticasone furoate, 27.5 mcg/actuation nasal spray (Lek Pharmaceuticals d.d.) with the reference formulation Veramyst® nasal spray (GlaxoSmithKline) in the relief of the signs and symptoms of seasonal allergic rhinitis. Participants who met the inclusion/exclusion criteria entered a 7-day placebo lead-in period. Following this placebo lead-in period, on Day 1 participants who continued to meet eligibility criteria were randomly assigned in a 2:2:1 ratio to one of three treatment groups (Test Product:Reference Product:Placebo) for 14 days of treatment. In all treatment groups, participants were instructed to administer the study drug once daily at approximately the same time each day. A single dose of 110 mcg was 4 actuations, each containing 27.5 mcg per actuation. Patients were instructed to administer the 4 actuations alternating between right and left nostril, such that 2 actuations were not administered back to back to the same nostril. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT01337323 -
Prospective Observational Study of Concomitant Allergic Rhinitis Treatment Patterns Among Patients Starting on Fluticasone Furoate Nasal Spray in a Retail Pharmacy Setting
|
N/A | |
| Completed |
NCT00851344 -
Allergen Challenge Chamber Study With Single Dose Oral GSK835726 Compared With Placebo
|
Phase 2 | |
| Completed |
NCT00501527 -
Immunotherapy With Depigmented and Polymerized Allergen Extract of Phleum Pratense
|
Phase 2 | |
| Completed |
NCT00537355 -
An Evaluation of the Efficacy and Safety of TOLAMBA™ for Ragweed-Allergic Rhinitis in an Environmental Exposure Chamber
|
Phase 2 | |
| Completed |
NCT00422149 -
Twin SUBLIVAC® Grasses Clinical Efficacy Study
|
Phase 3 | |
| Completed |
NCT00542607 -
Efficacy and Safety of Levocetirizine and Fexofenadine in Reducing Symptoms of Seasonal Allergic Rhinitis
|
Phase 4 | |
| Completed |
NCT00605852 -
Investigation Of a New Oral Anti-Histamine in Healthy Male Subjects
|
Phase 1 | |
| Active, not recruiting |
NCT05960266 -
Immunological Analysis of Lymph Node Tissue After Intralymphatic Immunotherapy: A Prospective Case Control Study
|
Early Phase 1 | |
| Completed |
NCT02256553 -
Safety Study of MK-3641 and MK-7243 Co-administered in Adult Participants With Ragweed and Grass Pollen Induced Allergic Rhinitis (P08607, MK-3641-006)
|
Phase 4 | |
| Completed |
NCT00932256 -
Clinical Trial of STAHIST in Seasonal Allergic Rhinitis Patients
|
Phase 1 | |
| Completed |
NCT01007721 -
Randomized, Placebo Controlled, Crossover Study in an Environmental Challenge Chamber to Assess Safety & Efficacy of Three Oral Doses of BI 671800 Versus Fluticasone Propionate and Montelukast in Sensitive Seasonal Allergic Rhinitis Patients Out of Season
|
Phase 2 | |
| Completed |
NCT00901914 -
Study of rBet v1 Tablets
|
Phase 2 | |
| Completed |
NCT00384475 -
A Study of Ciclesonide Nasal Spray in Patients 18 Years and Older With Seasonal Allergic Rhinitis (BY9010/M1-413)
|
Phase 3 | |
| Completed |
NCT00135629 -
Factors Predicting Efficacy of Allergen Injection Immunotherapy for Grass Pollen Hayfever
|
Phase 3 | |
| Completed |
NCT00839189 -
Effect of a 10,000 EU Dose of Endotoxin in Allergic and Mildly Asthmatic Adults
|
Phase 1 | |
| Completed |
NCT04687059 -
An Exploratory Study of PQ Grass 27600 SU
|
Phase 2/Phase 3 | |
| Completed |
NCT00889460 -
Safety and Tolerability Study of rBet v1 SLIT Tablets
|
Phase 1 | |
| Completed |
NCT00396149 -
Safety, Tolerability and Pharmacodynamic Effects of Sublingual Immunotherapy (Tablets) With Recombinant Bet v1
|
Phase 1 | |
| Completed |
NCT00659594 -
Study Using the Environmental Exposure Chamber (EEC) to Assess the Onset of Action of Ciclesonide, Applied as a Nasal Spray in Treatment of Seasonal Allergic Rhinitis (BY9010/M1-406)
|
Phase 3 | |
| Completed |
NCT00127647 -
An Approved Drug to Study a New Indication for Allergic Rhinitis (0476-327)
|
Phase 3 |