Rhinitis, Allergic, Seasonal Clinical Trial
Official title:
A Double-Blind, Randomized, Placebo Controlled, Parallel Group, Multi-Site Study to Compare the Clinical Equivalence of Mometasone Nasal Spray (Lek Pharmaceuticals) With NASONEX® Nasal Spray (Schering Corporation) in the Relief of the Signs and Symptoms of Seasonal Allergic Rhinitis
This study compared the efficacy and safety of a generic mometasone 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 mometasone furoate monohydrate, 50 mcg/actuation nasal spray (Lek Pharmaceuticals d.d.) with the reference formulation Nasonex® nasal spray (Schering) 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 200 mcg was 4 actuations, each containing 50 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 |
NCT00537355 -
An Evaluation of the Efficacy and Safety of TOLAMBA™ for Ragweed-Allergic Rhinitis in an Environmental Exposure Chamber
|
Phase 2 | |
| Completed |
NCT00501527 -
Immunotherapy With Depigmented and Polymerized Allergen Extract of Phleum Pratense
|
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 |
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 |
NCT00932256 -
Clinical Trial of STAHIST in Seasonal Allergic Rhinitis Patients
|
Phase 1 | |
| 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 |
NCT00839189 -
Effect of a 10,000 EU Dose of Endotoxin in Allergic and Mildly Asthmatic Adults
|
Phase 1 | |
| Completed |
NCT00135629 -
Factors Predicting Efficacy of Allergen Injection Immunotherapy for Grass Pollen Hayfever
|
Phase 3 | |
| 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 |
NCT00127647 -
An Approved Drug to Study a New Indication for Allergic Rhinitis (0476-327)
|
Phase 3 | |
| 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 |